Search results for " approval"
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FDA Framework Spurs Advanced Therapies
According to the International Society for Cellular Therapy (ISCT), the approval of the first CAR T-cell therapies is “direct evidence of the commercializing potential of CAR-T therapies” and indicate…
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
An FDA advisory committee voted unanimously to recommend approval of Novartis’ new CAR-T, despite concerns about the firm’s ability to process patient T-cells consistently and safely (1). Similar issu…
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Contract Manufacturing Through the Years
In the United States, drug product is contract manufactured for nearly 50% of all new drug application (NDA) approvals, and drug substance is contract manufactured for more than 50% of all small-molec…
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Biopharma in 2016: Higher Quality Drugs, Less Expensive Manufacturing
This new approval was for manufacturing Janssen Products, LP’s, medication for the treatment of HIV-1 infection, Prezista (darunavir). The company’s efforts in manufacturing advancement were facilitat…
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Biosimilars: Making the Switch Comes with Challenges
… analytical data at the production and preclinical stages when assessing applications for biosimilar approvals. At the start of EMA’s regulating of biosimilars, there were doubts about whether the ex…
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Quality by Design—Bridging the Gap between Concept and Implementation
A relatively small number of marketing approval applications made in Europe have supporting QbD data, with EMA conceding that application dossiers with QbD information are far from becoming a standard…
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Addressing the Challenges in Downstream Processing Today and Tomorrow
A broad range of alternative BioTx modalities have obtained regulatory approval and are currently in clinical trials (17–21) including antibody fragments, single-domain mAbs, Fc-fusions, vaccines, ant…
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Top Process Development Trends for 2022 and a Look into 2023
More than half of these approvals were for patients with rare diseases such as acid sphingomyelinase deficiency (an inherited disease that affects the body’s ability to metabolize fat) or generalized …
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Chromatography for the Diversified Antibody Pipeline
CytivaVideo
In this video, Eva Heldin, Section Manager of Antibody Application in R&D at Cytiva is interviewed by BioPharm International and shares what antibody therapies are in the pipelin…
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Maximum Output Starts with Optimized Upstream Processing
…ies to reduce the reliance on end-product testing, exploration of accelerated regulatory pathways to approval for emerging technologies, application of the use of digital twins to increase operationa…