A biopharmaceutical , also known as a biological medical product , or biologic , is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, they include vaccines , whole blood , blood components, allergenics , somatic cells , gene therapies , tissues , recombinant therapeutic protein , and living medicines used in cell therapy . Biologics can be composed of sugars , proteins , nucleic acids , or complex combinations of these substances, or may be living cells or tissues. They (or their precursors or components) are isolated from living sources—human, animal, plant, fungal, or microbial. They can be used in both human and animal medicine.
102-523: Cephalon, Inc. was an American biopharmaceutical company co-founded in 1987 by pharmacologist Frank Baldino, Jr ., neuroscientist Michael Lewis, and organic chemist James C. Kauer—all three former scientists with the DuPont Company . Baldino served as Cephalon's chairman and chief executive officer, until his death in December 2010. The company's name comes from the adjective "cephalic" meaning "related to
204-508: A virus to include a desirable piece of genetic material. Viral gene therapies using engineered plant viruses have been proposed to enhance crop performance and promote sustainable production. With the expiration of many patents for blockbuster biologics between 2012 and 2019, the interest in biosimilar production, i.e., follow-on biologics, has increased. Compared to small molecules that consist of chemically identical active ingredients , biologics are vastly more complex and consist of
306-729: A 24-hour particle pollution rating of D in the American Lung Association 's 2017 State of the Air report, which analyzed data from 2013 to 2015. The city was ranked 22nd for ozone, 20th for short-term particle pollution, and 11th for year-round particle pollution. According to the same report, the city experienced a significant reduction in high ozone days since 2001—from nearly 50 days per year to fewer than 10—along with fewer days of high particle pollution since 2000—from about 19 days per year to about 3—and an approximate 30% reduction in annual levels of particle pollution since 2000. Five of
408-495: A bachelor's degree or higher. 23.9% spoke a language other than English at home, the most common of which was Spanish (10.8%). 15.0% of the populations foreign born, roughly half of whom are naturalized U.S. citizens. 3.7% of the population are veterans. The median household income was $ 52,889 and 22.8% of the population lived in poverty. 49.5% of the population drove alone to work, while 23.2% used public transit, 8.2% carpooled, 7.9% walked, and 7.0% worked from home. The average commute
510-403: A budget of $ 371 million. The Philadelphia Parking Authority is responsible for ensuring adequate parking for city residents, businesses, and visitors. Philadelphia's architectural history dates back to colonial times and includes a wide range of styles. The earliest structures were constructed with logs , but brick structures were common by 1700. During the 18th century, the cityscape
612-474: A candidate that was never approved. Thereafter, the company developed and commercialized products for the treatment of sleep disorders, pain, addiction and cancer, establishing the "wake franchise" on the basis of Provigil ( modafinil ) and later, Nuvigil , the R -enantiomer of modafinil. In addition to conducting research on kinase inhibitors and other small molecules, Cephalon licensed other compounds, purchased other products, and acquired entire companies, in
714-467: A city on the Delaware River to serve as a port and place for government. Hoping that Philadelphia would become more like an English rural town instead of a city, Penn laid out roads on a grid plan to keep houses and businesses spread far apart with areas for gardens and orchards . The city's inhabitants did not follow Penn's plans, however, and instead crowded the present-day Port of Philadelphia on
816-492: A grid pattern between the Delaware and Schuylkill rivers that is aligned with their courses. The original city plan was designed to allow for easy travel and to keep residences separated by open space that would help prevent the spread of fire. In keeping with the idea of a "Greene Countrie Towne", and inspired by the many types of trees that grew in the region, Penn named many of the east–west streets for local trees. Penn planned
918-706: A growth in its population in 2007, which continued with incremental annual increases through the present. A migration pattern has been established from New York City to Philadelphia by residents opting for a large city with relative proximity and a lower cost of living . Philadelphia's geographic center is about 40° 0′ 34″ north latitude and 75° 8′ 0″ west longitude. The 40th parallel north passes through neighborhoods in Northeast Philadelphia , North Philadelphia , and West Philadelphia including Fairmount Park . The city encompasses 142.71 square miles (369.62 km ), of which 134.18 square miles (347.52 km )
1020-622: A joint effort between former mayors John F. Street and Michael Nutter . The zoning changes were intended to rectify incorrect zoning maps to facilitate future community development, as the city forecasts an additional 100,000 residents and 40,000 jobs will be added by 2035. The Philadelphia Housing Authority (PHA) is the largest landlord in Pennsylvania. Established in 1937, the PHA is the nation's fourth-largest housing authority, serving about 81,000 people with affordable housing, while employing 1,400 on
1122-562: A lawsuit for $ 17 million in which it had faced claims that Baldino and other company executives had overstated the potential for a drug aimed at treating amyotrophic lateral sclerosis (Lou Gehrig's disease). In addition, the Federal Trade Commission filed suit against Cephalon, stating that it had made "illegal deals with generic drug companies to delay generic competition to Provigil", an accusation that Cephalon has reportedly disputed. In September 2008, Cephalon paid $ 425 million to
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#17328694632101224-550: A moderately sunny climate with an average of 2,498 hours of sunshine annually. The percentage of sunshine ranges from 47% in December to 61% in June, July, and August. The January daily average temperature is 33.7 °F (0.9 °C). The temperature frequently rises to 50 °F (10 °C) during thaws. July averages 78.7 °F (25.9 °C). Heat waves accompanied by high humidity and heat indices are frequent, with highs reaching or exceeding 90 °F (32 °C) on 30 days of
1326-472: A multitude of subspecies. Due to their heterogeneity and the high process sensitivity, originators and follow-on biosimilars will exhibit variability in specific variants over time. The safety and clinical performance of both originator and biosimilar biopharmaceuticals must remain equivalent throughout their lifecycle. Process variations are monitored by modern analytical tools (e.g., liquid chromatography , immunoassays , mass spectrometry , etc.) and describe
1428-1124: A supply shortage for these products. Institutions housing these biologics, designated as 'banks', often cannot distribute their product to customers effectively. Conversely, banks for reproductive cells are much more widespread and available due to the ease with which spermatozoa and egg cells can be used for fertility treatment. Biopharmaceuticals may be produced from microbial cells (e.g., recombinant E. coli or yeast cultures), mammalian cell lines (see Cell culture ) and plant cell cultures (see Plant tissue culture ) and moss plants in bioreactors of various configurations, including photo-bioreactors . Important issues of concern are cost of production (low-volume, high-purity products are desirable) and microbial contamination (by bacteria , viruses , mycoplasma ). Alternative platforms of production which are being tested include whole plants ( plant-made pharmaceuticals ). A potentially controversial method of producing biopharmaceuticals involves transgenic organisms, particularly plants and animals that have been genetically modified to produce drugs. This production
1530-600: A therapeutic agent for a drug-resistant leukemia , in the oncology therapeutic area. Longtime chief financial officer J. Kevin Buchi succeeded Baldino as CEO in 2011. Members of the board included: venture capitalist William Egan, former COR Therapeutics CEO Vaughan Kailian, prominent healthcare economist Dr. Gail Wilensky , former SmithKline Beecham executive Dr. Martyn Greenacre, former Harvard physician and Glaxo USA head Dr. Charles Sanders and former Ambassador Kevin Moley. The company
1632-850: A time, row houses built elsewhere in the United States were known as "Philadelphia rows". A variety of row houses are found throughout the city, from Federal-style continuous blocks in Old City and Society Hill to Victorian-style homes in North Philadelphia to twin row houses in West Philadelphia . While newer homes have been built recently, much of the housing dates to the 18th, 19th, and early 20th centuries, which has created problems such as urban decay and vacant lots. Some neighborhoods, including Northern Liberties and Society Hill, have been rehabilitated through gentrification . As of 2014 ,
1734-636: A town in Finland with a Swedish majority. In 1655, a Dutch military campaign led by New Netherland Director-General Peter Stuyvesant took control of the Swedish colony, ending its claim to independence. The Swedish and Finnish people settlers continued to have their own militia , religion, and court, and to enjoy substantial autonomy under the Dutch. An English fleet captured the New Netherland colony in 1664, though
1836-404: A unique design space for each biologic. Biosimilars require a different regulatory framework compared to small-molecule generics. Legislation in the 21st century has addressed this by recognizing an intermediate ground of testing for biosimilars. The filing pathway requires more testing than for small-molecule generics, but less testing than for registering completely new therapeutics. In 2003,
1938-785: A wide range of biological products in medicine. However, in most cases, the term is used more restrictively for a class of therapeutics (either approved or in development) that are produced using biological processes involving recombinant DNA technology. These medications are usually one of three types: Biologics as a class of medications in this narrower sense have had a profound impact on many medical fields, primarily rheumatology and oncology , but also cardiology , dermatology , gastroenterology , neurology , and others. In most of these disciplines, biologics have added major therapeutic options for treating many diseases, including some for which no effective therapies were available, and others where previously existing therapies were inadequate. However,
2040-616: Is pharmaceutics that works with biopharmaceuticals. Biopharmacology is the branch of pharmacology that studies biopharmaceuticals. Specialty drugs , a recent classification of pharmaceuticals, are high-cost drugs that are often biologics. The European Medicines Agency uses the term advanced therapy medicinal products (ATMPs) for medicines for human use that are "based on genes, cells, or tissue engineering", including gene therapy medicines, somatic-cell therapy medicines, tissue-engineered medicines, and combinations thereof. Within EMA contexts,
2142-453: Is a significant risk for its investor due to production failure or scrutiny from regulatory bodies based on perceived risks and ethical issues. Biopharmaceutical crops also represent a risk of cross-contamination with non-engineered crops, or crops engineered for non-medical purposes. One potential approach to this technology is the creation of a transgenic mammal that can produce the biopharmaceutical in its milk, blood, or urine. Once an animal
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#17328694632102244-469: Is consistent with our strategy to diversify into biologics and provides us with an important phase three asset for further development." At the time of Baldino's death in 2010, the company he had co-founded in 1987 was best known for the alertness drug Provigil , the painkiller Actiq , and the seizure disorder medication Gabitril . In 2011, Cephalon agreed to acquire ChemGenex Pharmaceuticals, which would provided Cephalon with marketing rights to Omapro ,
2346-461: Is highly variable. Some winters have only light snow while others include major snowstorms. The normal seasonal snowfall averages 22.4 in (57 cm), with rare snowfalls in November or April, and rarely any sustained snow cover. Seasonal snowfall accumulation has ranged from trace amounts in 1972–73, to 78.7 inches (200 cm) in the winter of 2009–10. The city's heaviest single-storm snowfall
2448-487: Is home to five Fortune 500 corporate headquarters. Metropolitan Philadelphia ranks as one of the Big Five U.S. venture capital hubs, facilitated by its geographic proximity to both the entrepreneurial and financial ecosystems of New York City and to the federal regulatory environment of Washington, D.C. Greater Philadelphia is also a biotechnology hub. The Philadelphia Stock Exchange , owned by Nasdaq since 2008,
2550-639: Is land and 8.53 square miles (22.09 km ), or 6%, is water. Natural bodies of water include the Delaware and Schuylkill rivers, lakes in Franklin Delano Roosevelt Park , and Cobbs , Wissahickon , and Pennypack creeks. The largest artificial body of water is East Park Reservoir in Fairmount Park . The lowest point is sea level and the highest point is in Chestnut Hill , about 446 feet (136 m) above sea level on Summit Street near
2652-495: Is often ranked as the nation's best city for professional sports fans. The city has a culturally and philanthropically active LGBTQ+ community . Philadelphia also has played an immensely influential historic and ongoing role in the development and evolution of American music, especially R&B , soul , and rock . As of 2022 , the Philadelphia metropolitan area had a gross metropolitan product of US$ 518.5 billion and
2754-578: Is one of the largest contiguous urban park areas in the U.S. The two parks, along with the Colonial Revival , Georgian and Federal -style mansions in them, have been listed as one entity on the National Register of Historic Places since 1972. Within the Köppen climate classification , Philadelphia falls under the northern periphery of the humid subtropical climate zone (Köppen Cfa ). Within
2856-546: Is produced, typically using the pronuclear microinjection method, it becomes efficacious to use cloning technology to create additional offspring that carry the favorable modified genome. The first such drug manufactured from the milk of a genetically modified goat was ATryn , but marketing permission was blocked by the European Medicines Agency in February 2006. This decision was reversed in June 2006 and approval
2958-433: Is the nation's oldest stock exchange and a global leader in options trading. 30th Street Station , the city's primary rail station, is the third-busiest Amtrak hub in the nation, and the city's multimodal transportation and logistics infrastructure also includes Philadelphia International Airport , a major transatlantic gateway and transcontinental hub; the rapidly-growing PhilaPort seaport ; and Interstate 95 ,
3060-456: The 2020 U.S. Census , there were 1,603,797 people residing in Philadelphia, representing a 1.2% increase from the 2019 census estimate. The racial composition of the city was 39.3% Black alone (42.0% Black alone or in combination), 36.3% White alone (41.9% White alone or in combination), 8.7% Asian alone, 0.4% American Indian and Alaska Native alone, 8.7% some other race, and 6.9% multiracial. 14.9% of residents were Hispanic or Latino. 34.8% had
3162-813: The Battle of Brandywine in Chadds Ford Township , on September 11, 1777, during the Philadelphia campaign , the revolutionary capital of Philadelphia was defenseless and the city prepared for what was perceived to be an inevitable British attack. Because bells could easily be recast into munitions, the Liberty Bell , then known as the Pennsylvania State Bell, and bells from two Philadelphia churches, Christ Church and St. Peter's Church , were hastily taken down and transported by heavily guarded wagon train out of
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3264-612: The British Army , which was then the world's most powerful military force. Since the Declaration's July 4, 1776, adoption, its signing has been cited globally and repeatedly by various peoples of the world seeking independence and liberty. It also has been, since its adoption, the basis for annual celebration by Americans; in 1938, this celebration of the Declaration was formalized as Independence Day , one of only eleven designated U.S. federal holidays . After George Washington 's defeat at
3366-594: The Delaware River watershed , western Long Island , and the Lower Hudson Valley . Most Lenape were pushed out of the region during the 18th century by expanding European colonies, exacerbated by losses from intertribal conflicts. Lenape communities were weakened by newly introduced diseases, mainly smallpox , and conflict with Europeans. The Iroquois occasionally fought the Lenape. Surviving Lenape moved west into
3468-667: The Eastern Mediterranean during the Greek and Roman periods, including modern Alaşehir , mentioned as the site of an early Christian congregation in the Book of Revelation . As a Quaker , Penn had experienced religious persecution and wanted his colony to be a place where anyone could worship freely. This tolerance, which exceeded that of other colonies, led to better relations with the local native tribes and fostered Philadelphia's rapid growth into America's most important city. Penn planned
3570-581: The European Medicines Agency introduced an adapted pathway for biosimilars, termed similar biological medicinal products . This pathway is based on a thorough demonstration of comparability of the product to an existing approved product. Within the United States, the Patient Protection and Affordable Care Act of 2010 created an abbreviated approval pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed reference biological product. Researchers are optimistic that
3672-566: The Great Migration from the South . By the 20th century, Philadelphia had an entrenched Republican political machine and a complacent population. In 1910, a general strike shut down the entire city. In 1917, following outrage over the election-year murder of a Philadelphia police officer, led to the shrinking of the City Council from two houses to just one. In July 1919, Philadelphia
3774-666: The Second Continental Congress , which adopted the Declaration of Independence in what was then called the Pennsylvania State House and was later renamed Independence Hall. Historian Joseph Ellis , in 2007, described the Declaration of Independence, written predominantly by Thomas Jefferson , as "the most potent and consequential words in American history," and its adoption represented a declaration of war against
3876-475: The Trewartha climate classification , Philadelphia has a temperate maritime climate ( Do ) limited to the north by the continental climate ( Dc ). Summers are typically hot and muggy. Fall and spring are generally mild, and winter is moderately cold. The plant life hardiness zones are 7a and 7b, reflecting an average annual extreme minimum temperature between 0 and 10 °F (−18 and −12 °C). Snowfall
3978-448: The world's 54th-largest urban park . Philadelphia is known for its arts, culture , cuisine , and colonial and Revolutionary-era history; in 2016, it attracted 42 million domestic tourists who spent $ 6.8 billion, representing $ 11 billion in economic impact to the city and its surrounding Pennsylvania counties. With five professional sports teams and one of the nation's most loyal and passionate fan bases, Philadelphia
4080-490: The 1980s. Historic areas such as Old City and Society Hill were renovated during the reformist mayoral era of the 1950s through the 1980s, making both areas among the most desirable Center City neighborhoods. Immigrants from around the world began to enter the U.S. through Philadelphia as their gateway, leading to a reversal of the city's population decline between 1950 and 2000, during which it lost about 25 percent of its residents. Philadelphia eventually began experiencing
4182-649: The 2 square miles (5.2 km ) of Center City to the roughly 134 square miles (350 km ) of Philadelphia County . In the latter half of the 19th century and leading into the 20th century, immigrants from Russia, Eastern Europe, and Italy, and African Americans from the southern U.S. settled in the city. Philadelphia was represented by the Washington Grays in the American Civil War . The African-American population of Philadelphia increased from 31,699 to 219,559 between 1880 and 1930, largely stemming from
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4284-549: The Australian biotechnology firm, Arana Therapeutics, which brought Cephalon its lead biologic candidate, ART621, a candidate for inflammatory diseases, and biologics for the treatment of cancers. Then, as infogrok.com noted in February 2010, "Cephalon... exercised its option to acquire Ception Therapeutics, following receipt of positive data from a clinical study in adults with eosinophilic asthma." Commenting on this, Frank Baldino Jr., CEO of Cephalon, said, "The acquisition of Ception
4386-511: The Biologics and Genetic Therapies Directorate within Health Canada . Philadelphia Philadelphia , colloquially referred to as Philly , is the most populous city in the U.S. state of Pennsylvania and the sixth-most populous city in the United States , with a population of 1,603,797 in the 2020 census . The city is the urban core of the larger Delaware Valley , also known as
4488-501: The Delaware River and subdivided and resold their lots. Before Penn left Philadelphia for the final time, he issued the Charter of 1701 establishing it as a city. Though poor at first, Philadelphia became an important trading center with tolerable living conditions by the 1750s. Benjamin Franklin , a leading citizen, helped improve city services and founded new ones that were among the first in
4590-456: The Philadelphia metropolitan area, the nation's eighth-largest metropolitan area and seventh-largest combined statistical area with 6.245 million residents and 7.366 million residents, respectively. Philadelphia has played an extensive role in United States history . The city was founded in 1682 by William Penn , an English Quaker and advocate of religious freedom , and served as
4692-753: The Second Continental Congress adopted the Articles of Confederation on November 15, 1777, and the city later served as the meeting place for the Constitutional Convention , which ratified the Constitution in Independence Hall in Philadelphia on September 17, 1787. Philadelphia served as capital of the United States for much of the colonial and early post-colonial periods, including for a decade, from 1790 to 1800, while Washington, D.C. ,
4794-578: The United States after Midtown Manhattan in New York City. Philadelphia's neighborhoods are divided into six large sections that surround Center City: North Philadelphia , Northeast Philadelphia , South Philadelphia , Southwest Philadelphia , West Philadelphia , and Northwest Philadelphia . The city's geographic boundaries have been largely unchanged since these neighborhoods were consolidated in 1854. However, each of these large areas contains numerous neighborhoods, some of whose boundaries derive from
4896-436: The advent of biologic therapeutics has also raised complex regulatory issues (see below), and significant pharmacoeconomic concerns because the cost for biologic therapies has been dramatically higher than for conventional (pharmacological) medications. This factor has been particularly relevant since many biological medications are used to treat chronic diseases , such as rheumatoid arthritis or inflammatory bowel disease, or for
4998-560: The biopharmaceutical industry, generating 37 percent of the total number of granted patents worldwide; however, there is still a large margin for growth and innovation within the industry. Revisions to the current IP system to ensure greater reliability for R&D (research and development) investments is a prominent topic of debate in the US as well. Blood products and other human-derived biologics such as breast milk have highly regulated or very hard-to-access markets; therefore, customers generally face
5100-464: The boroughs, townships, and other communities that constituted Pennsylvania County before their inclusion within the city. The City Planning Commission , tasked with guiding growth and development of the city, has divided the city into 18 planning districts as part of the Philadelphia2035 physical development plan. Much of the city's 1980 zoning code was overhauled from 2007 to 2012 as part of
5202-639: The capital of the Pennsylvania Colony during the British colonial era . The city went on to play a historic and vital role during the American Revolution and Revolutionary War , serving as the central meeting place for the nation's founding fathers , hosting the First Continental Congress in 1774, preserving the Liberty Bell , and hosting the Second Continental Congress during which
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#17328694632105304-575: The city for its outlying railroad commuting towns and newer housing. The resulting reduction in Philadelphia's tax base and the resources of local government caused the city to struggle through a long period of adjustment, and it approached bankruptcy by the late 1980s. In 1985, the MOVE Bombing of the Cobbs Creek neighborhood by city helicopters occurred, killing 11 and destroying 61 homes. Revitalization and gentrification of neighborhoods began in
5406-517: The city's 17th century founding through the present, Philadelphia has been the birthplace or home to an extensive number of prominent and influential Americans . Prior to the arrival of Europeans in the early 17th century, the Philadelphia area was home to the Lenape Indians in the village of Shackamaxon . They were also called the Delaware Indians, and their historical territory was along
5508-456: The city's director of public safety, but political pressure still prevented long-term success in fighting crime and corruption. In 1940, non-Hispanic whites constituted 86.8% of the city's population. In 1950, the population peaked at more than two million residents, then began to decline with the restructuring of industry that led to the loss of many middle-class union jobs. In addition, suburbanization enticed many affluent residents to depart
5610-399: The city's tallest building. The Comcast Technology Center was completed in 2018, reaching a height of 1,121 ft (342 m), as the tallest building in the United States outside of Manhattan and Chicago. For much of Philadelphia's history, the typical home has been the row house . The row house was introduced to the United States via Philadelphia in the early 19th century and, for
5712-511: The city's total park space, including municipal, state, and federal parks in the city, amounts to 11,211 acres (17.5 sq mi). Philadelphia's largest park is Fairmount Park , which includes the Philadelphia Zoo and encompasses 2,052 acres (3.2 sq mi) of the total parkland. Fairmount Park's adjacent Wissahickon Valley Park contains 2,042 acres (3.2 sq mi). Fairmount Park, when combined with Wissahickon Valley Park,
5814-403: The city, Philadelphia is one of the nation's leading centers for higher education and academic research . The city is a national cultural center, hosting more outdoor sculptures and murals than any other city in the nation. Fairmount Park , when combined with adjacent Wissahickon Valley Park in the same watershed , is 2,052 acres (830 ha), representing one of the nation's largest and
5916-676: The city. The Liberty Bell was taken to Zion German Reformed Church in Northampton Town, which is present-day Allentown , where it was hidden under the church's floor boards for nine months from September 1777 until the British Army's departure from Philadelphia in June 1778. Two Revolutionary War battles, the Siege of Fort Mifflin , fought between September 26 and November 16, 1777, and the Battle of Germantown , fought on October 4, 1777, took place within Philadelphia's city limits. In Philadelphia,
6018-522: The colonies made it a natural center for America's revolutionaries . By the 1750s, Philadelphia surpassed Boston as the largest city and busiest port in British America , and the second-largest city in the entire British Empire after London . In 1774, as resentment of British colonial practices and support for independence was burgeoning in the colonies, Philadelphia hosted the First Continental Congress . From 1775 to 1781, Philadelphia hosted
6120-466: The colony. Penn made a treaty of friendship with Lenape chief Tammany under an elm tree at Shackamaxon , in what is now the city's Fishtown neighborhood. Penn named the city Philadelphia, which is Greek for "brotherly love", derived from the Ancient Greek terms φίλος phílos (beloved, dear) and ἀδελφός adelphós (brother, brotherly). There were a number of cities named Philadelphia in
6222-402: The country, and the first Black Episcopal Church . The free Black community also established many schools for its children with the help of Quakers . Large-scale construction projects for new roads, canals , and railroads made Philadelphia the first major industrial city in the United States. Throughout the 19th century, Philadelphia hosted a variety of industries and businesses; the largest
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#17328694632106324-486: The creation of five public parks in the city which were renamed in 1824. Centre Square was renamed Penn Square ; Northeast Square was renamed Franklin Square ; Southeast Square was renamed Washington Square ; Southwest Square was renamed Rittenhouse Square ; and Northwest Square was renamed Logan Circle/Square . Center City had an estimated 183,240 residents as of 2015 , making it the second-most populated downtown area in
6426-472: The drug is released, it will still be monitored for performance and safety risks. The manufacture process must satisfy the FDA's "Good Manufacturing Practices", which are typically manufactured in a cleanroom environment with strict limits on the amount of airborne particles and other microbial contaminants that may alter the efficacy of the drug. In Canada , biologics (and radiopharmaceuticals) are reviewed through
6528-429: The federal government to settle four whistleblower lawsuits and a criminal charge alleging Cephalon had marketed Actiq, Gabitril and Provigil for “off-label” (unapproved) uses. Select products that Cephalon manufactured and marketed included: Biopharmaceutical Terminology surrounding biopharmaceuticals varies between groups and entities, with different terms referring to different subsets of therapeutics within
6630-600: The first modern International Style skyscraper in the United States, the PSFS Building , designed by George Howe and William Lescaze . The 548 ft (167 m) City Hall remained the tallest building in the city until 1987 when One Liberty Place was completed. Numerous glass and granite skyscrapers were built in Center City beginning in the late 1980s. In 2007, the Comcast Center surpassed One Liberty Place to become
6732-530: The first official World's fair in the U.S. Immigrants, mostly from Ireland and Germany, settled in Philadelphia and the surrounding districts. These immigrants were largely responsible for the first general strike in North America in 1835, in which workers in the city won the ten-hour workday. The city was a destination for thousands of Irish immigrants fleeing the Great Famine in the 1840s; housing for them
6834-419: The general biopharmaceutical category. Some regulatory agencies use the terms biological medicinal products or therapeutic biological product to refer specifically to engineered macromolecular products like protein- and nucleic acid -based drugs , distinguishing them from products like blood, blood components, or vaccines, which are usually extracted directly from a biological source. Biopharmaceutics
6936-461: The head or brain", as it was established primarily to pursue treatments for neurodegenerative diseases . As noted by fundinguniverse.com : Cephalon initially avoided involving itself in activities that would require maintaining a sales staff, managing clinical trials, and shepherding new drugs through the Food and Drug Administration (FDA) approval process. With no product to sell, Cephalon's only asset
7038-604: The intersection of Germantown Avenue and Bethlehem Pike at: 40.07815 N, 75.20747 W. Philadelphia is located on the Atlantic Seaboard Fall Line that separates the Atlantic Plain from the Piedmont . The Schuylkill River's rapids at East Falls were inundated by completion of the dam at Fairmount Water Works . The city is the seat of its own county . The city is bordered by six adjacent counties: Montgomery to
7140-447: The introduction of biosimilars will reduce medical expenses to patients and the healthcare system. When a new biopharmaceutical is developed, the company will typically apply for a patent , which is a grant to exclusive manufacturing rights. This is the primary means by which the drug developer can recover the investment cost for development of the biopharmaceutical. The patent laws in the United States and Europe differ somewhat on
7242-551: The last occurrence of such a temperature being July 21, 2019. The lowest officially recorded temperature was −11 °F (−24 °C) on February 9, 1934. Temperatures at or below 0 °F (−18 °C) are rare, with the last such occurrence being January 19, 1994 . The record low maximum is 5 °F (−15 °C) on February 10, 1899, and December 30, 1880. The record high minimum is 83 °F (28 °C) on July 23, 2011, and July 24, 2010. See or edit raw graph data . Philadelphia County received an ozone grade of F and
7344-540: The late 1970s and continues into the 21st century with much of the development occurring in the Center City and University City neighborhoods. But this expanded a shortage of affordable housing in the city. After many manufacturers and businesses left Philadelphia or shut down, the city started attracting service businesses and began to market itself more aggressively as a tourist destination. Contemporary glass-and-granite skyscrapers were built in Center City beginning in
7446-415: The latter case, including CIMA Labs, Anesta, and Laboratoire Lafon. It was from Lafon that Cephalon obtained the rights to modafinil , which it marketed under the trade name Provigil , for the treatment of excessive daytime sleepiness associated with narcolepsy , sleep apnea , and shift work sleep disorder . Sales of Provigil reached nearly one billion dollars in 2008. In February 2009, Cephalon acquired
7548-563: The nation's 56 founders formed the Continental Army and elected George Washington as its commander in 1775, and unanimously adopted the Declaration of Independence on July 4, 1776. For nine months, from September 1777 to June 1778, the city fell under British occupation during the war's Philadelphia campaign . In 1787, the U.S. Constitution was ratified in Philadelphia at the Philadelphia Convention . Philadelphia remained
7650-479: The nation's largest city until 1790, and it served as the nation's first capital from May 10, 1775, until December 12, 1776, and on four subsequent occasions until 1800, when construction of the new national capital in Washington, D.C. was completed. Philadelphia maintains extensive contemporary influence in business and industry , culture , sports , and music . With 17 four-year universities and colleges in
7752-927: The nation, including a fire company , library , and hospital . A number of philosophical societies were formed, which were centers of the city's intellectual life, including the Philadelphia Society for Promoting Agriculture (1785), the Pennsylvania Society for the Encouragement of Manufactures and the Useful Arts (1787), the Academy of Natural Sciences (1812), and the Franklin Institute (1824). These societies developed and financed new industries that attracted skilled and knowledgeable immigrants from Europe. Philadelphia's importance and central location in
7854-449: The northwest; Bucks to the north and northeast; Burlington County, New Jersey to the east; Camden County, New Jersey to the southeast; Gloucester County, New Jersey to the south; and Delaware County to the southwest. Philadelphia was created in the 17th century, following the plan by William Penn 's surveyor Thomas Holme . Center City is structured with long, straight streets running nearly due east–west and north–south, forming
7956-483: The production process and its control. For example: In the United States , biologics are licensed through the biologics license application (BLA), then submitted to and regulated by the FDA's Center for Biologics Evaluation and Research (CBER) whereas drugs are regulated by the Center for Drug Evaluation and Research . Approval may require several years of clinical trials , including trials with human volunteers. Even after
8058-458: The requirements for a patent, with the European requirements perceived as more difficult to satisfy. The total number of patents granted for biopharmaceuticals has risen significantly since the 1970s. In 1978 the total patents granted was 30. This had climbed to 15,600 in 1995, and by 2001 there were 34,527 patent applications. In 2012 the US had the highest IP (Intellectual Property) generation within
8160-745: The second half of the 19th century. His contemporaries included John McArthur Jr. , Addison Hutton , Wilson Eyre , the Wilson Brothers , and Horace Trumbauer . In 1871, construction began on the Second Empire -style Philadelphia City Hall . The Philadelphia Historical Commission was created in 1955 to preserve the cultural and architectural history of the city. The commission maintains the Philadelphia Register of Historic Places , adding historic buildings, structures, sites, objects and districts as it sees fit. In 1932, Philadelphia became home to
8262-592: The situation did not change substantially until 1682, when the area was included in William Penn 's charter for Pennsylvania. In 1681, in partial repayment of a debt, Charles II of England granted Penn a charter for what would become the Pennsylvania colony . Despite the royal charter, Penn bought the land from the local Lenape in an effort to establish good terms with the Native Americans and ensure peace for
8364-467: The spine of the north–south highway system along the U.S. East Coast . Philadelphia is a city of many firsts, including the nation's first library (1731), hospital (1751), medical school (1765), national capital (1774), university (by some accounts) (1779), central bank (1781), stock exchange (1790), zoo (1874), and business school (1881). Philadelphia contains 67 National Historic Landmarks , including Independence Hall . From
8466-493: The surrounding Delaware Valley in the early 17th century. The first settlements were founded by Dutch colonists , who built Fort Nassau on the Delaware River in 1623 in what is now Brooklawn, New Jersey . The Dutch considered the entire Delaware River valley to be part of their New Netherland colony. In 1638, Swedish settlers led by renegade Dutch established the colony of New Sweden at Fort Christina , located in present-day Wilmington, Delaware , and quickly spread out in
8568-522: The ten largest combined statistical areas (CSAs) were ranked higher for ozone: Los Angeles (1st), New York City (9th), Houston (12th), Dallas (13th), and San Jose, California (18th). Many smaller CSAs were also ranked higher for ozone, including Sacramento (8th), Las Vegas (10th), Denver (11th), El Paso (16th), and Salt Lake City (20th). Only two of those same ten CSAs, San Jose and Los Angeles, were ranked higher than Philadelphia for both year-round and short-term particle pollution. As of
8670-474: The term advanced therapies refers specifically to ATMPs, although that term is rather nonspecific outside those contexts. Gene-based and cellular biologics, for example, often are at the forefront of biomedicine and biomedical research , and may be used to treat a variety of medical conditions for which no other treatments are available. Building on the market approvals and sales of recombinant virus-based biopharmaceuticals for veterinary and human medicine,
8772-541: The treatment of otherwise untreatable cancer during the remainder of life. The cost of treatment with a typical monoclonal antibody therapy for relatively common indications is generally in the range of €7,000–14,000 per patient per year. Older patients who receive biologic therapy for diseases such as rheumatoid arthritis , psoriatic arthritis , or ankylosing spondylitis are at increased risk for life-threatening infection, adverse cardiovascular events, and malignancy . The first such substance approved for therapeutic use
8874-606: The upper Ohio River basin. Following the American Revolutionary War and subsequent formation of an independent United States, the Lenape began moving further west. In the 1860s, the United States government sent most remaining Lenape in the eastern United States to the Indian Territory in present-day Oklahoma and surrounding territories as part of the Indian removal policy. Europeans first entered Philadelphia and
8976-546: The use of engineered plant viruses has been proposed to enhance crop performance and promote sustainable production. In some jurisdictions, biologics are regulated via different pathways from other small molecule drugs and medical devices . Some of the oldest forms of biologics are extracted from the bodies of animals, and other humans especially. Important biologics include: Some biologics that were previously extracted from animals, such as insulin, are now more commonly produced by recombinant DNA . Biologics can refer to
9078-567: The valley. In 1644, New Sweden supported the Susquehannocks in their war against Maryland colonists. In 1648, the Dutch built Fort Beversreede on the west bank of the Delaware, south of the Schuylkill River near the present-day Eastwick section of Philadelphia, to reassert their dominion over the area. The Swedes responded by building Fort Nya Korsholm , or New Korsholm , named after
9180-414: The world at that time. On May 2, 2011, Teva Pharmaceutical Industries announced it would acquire Cephalon. The deal was completed on October 11, 2011. The company's early research efforts were focused on the development of IGF-1 , an insulin-like growth factor , in collaboration with Chiron Corporation , toward the development of a treatment for amyotrophic lateral sclerosis (Lou Gehrig's Disease),
9282-491: The year. The average window for freezing temperatures is November 6 to April 2, allowing a growing season of 217 days. Early fall and late winter are generally dry, with February having the lowest average precipitation at 2.75 inches (70 mm). The dewpoint in the summer averages between 59.1 and 64.5 °F (15 and 18 °C). The highest recorded temperature was 106 °F (41 °C) on August 7, 1918. Temperatures at or above 100 °F (38 °C) are not common, with
9384-536: Was 30.7 in (78 cm), which occurred in January 1996. Precipitation is generally spread throughout the year, with eight to eleven wet days per month, at an average annual rate of 44.1 inches (1,120 mm), but historically ranging from 29.31 in (744 mm) in 1922 to 64.33 in (1,634 mm) in 2011. The most rain recorded in one day occurred on July 28, 2013, when 8.02 in (204 mm) fell at Philadelphia International Airport . Philadelphia has
9486-466: Was being constructed and prepared to serve as the new national capital. In 1793, the largest yellow fever epidemic in U.S. history killed approximately 4,000 to 5,000 people in Philadelphia, or about ten percent of the city's population at the time. The capital of the United States was moved to Washington, D.C. in 1800 upon completion of the White House and U.S. Capitol buildings. The state capital
9588-595: Was biosynthetic "human" insulin made via recombinant DNA . Sometimes referred to as rHI, under the trade name Humulin , was developed by Genentech , but licensed to Eli Lilly and Company , who manufactured and marketed it starting in 1982. Major kinds of biopharmaceuticals include: Research and development investment in new medicines by the biopharmaceutical industry stood at $ 65.2 billion in 2008. A few examples of biologics made with recombinant DNA technology include: Many vaccines are grown in tissue cultures. Viral gene therapy involves artificially manipulating
9690-506: Was developed south of South Street and later occupied by succeeding immigrants. They established a network of Catholic churches and schools and dominated the Catholic clergy for decades. Anti- Irish , anti-Catholic nativist riots erupted in Philadelphia in 1844. The rise in population of the surrounding districts helped lead to the Act of Consolidation of 1854 , which extended the city limits from
9792-477: Was dominated by Georgian architecture , including Independence Hall and Christ Church . In the first decades of the 19th century, Federal and Greek Revival architecture were the dominant styles produced by Philadelphia architects such as Benjamin Latrobe , William Strickland , John Haviland , John Notman , Thomas Walter , and Samuel Sloan . Frank Furness is considered Philadelphia's greatest architect of
9894-484: Was given August 2006. In the European Union , a biological medicinal product is one of the active substance(s) produced from or extracted from a biological (living) system, and requires, in addition to physicochemical testing, biological testing for full characterisation. The characterisation of a biological medicinal product is a combination of testing the active substance and the final medicinal product together with
9996-500: Was headquartered west of Philadelphia , in Frazer, Pennsylvania , and had research operations in nearby West Chester and manufacturing and other operations in suburban Minneapolis, Minnesota and Salt Lake City, Utah . European operations were based near Paris, France. After the acquisition of Arana, Research and Development operations continued in Sydney, Australia. In 1999 Cephalon settled
10098-473: Was its scientific expertise. That expertise proved sufficient to attract investors, and the company managed to fund its operations through research grants and contracts with larger pharmaceutical firms. Cephalon was first included in the Fortune 1000 list of U.S. companies based upon annual revenues for 2006. Sales revenues reached $ 2.8 billion in 2010, ranking Cephalon among the leading biopharmaceutical companies in
10200-515: Was moved from Philadelphia to Lancaster in 1799, then ultimately to Harrisburg in 1812. Philadelphia remained the nation's largest city until the late 18th century. It also was the nation's financial and cultural center until ultimately being eclipsed in total population by New York City in 1790. In 1816, the city's free Black community founded the African Methodist Episcopal Church , the first independent Black denomination in
10302-406: Was one of more than 36 industrial cities nationally to suffer a race riot during Red Summer in post- World War I unrest as recent immigrants competed with Blacks for jobs. In the 1920s, the public flouting of Prohibition laws, organized crime , mob violence, and corrupt police involvement in illegal activities led to the appointment of Brig. Gen. Smedley Butler of the U.S. Marine Corps as
10404-674: Was the textile industry . Major corporations in the 19th and early 20th centuries included the Baldwin Locomotive Works , William Cramp & Sons Shipbuilding Company , and the Pennsylvania Railroad . Established in 1870, the Philadelphia Conveyancers' Association was chartered by the state in 1871. Along with the U.S. Centennial in 1876, the city's industry was celebrated in the Centennial Exposition ,
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