Search results for " 2018"
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Biopharmaceutical Process Development: 2018 Lessons and 2019 Predictions
What might be in store for 2019, and what important lessons should process developers take from 2018? Here, we look back at some of the most popular Process Development Forum articles from 2018 for cl…
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Process Development: What May Lie Ahead in 2018?
… Process Development Forum articles from 2017 for insight about what may be heading down the pike in 2018.
Continued Growth
New drug approvals are on an upward trajectory. While onl…
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State of the Biopharmaceutical Industry: Lessons from 2018 Survey Data
What new areas did you explore in this year’s survey?
In 2018, and in recent years, we are seeing not just increased interest in and desires for adoption of continuous bioprocessing, but also expe…
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Fifteen Years of Progress: Biopharmaceutical Industry Survey Results
This article highlights some of the significant changes in biopharmaceutical manufacturing (bioprocessing) that have occurred from 2003 to 2018. Most all of the changes in bioprocessing that have occu…
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Biopharma Seeks Balance
To increase the potential for approval, companies need to provide better “packages” that describe how the drug works, said Scott Gottlieb, FDA commissioner, at the 2018 BIO convention in Boston on Jun…
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Industry Adoption of Single-Use Systems Remains Low
One example of how modular manufacturing is evolving to fit capacity needs is Cytiva’s deal in January 2018 to equip a cell therapy manufacturing facility with the FlexFactory platform, which the comp…
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Reimagining Affordable Biosimilars
Advances in preclinical development play a crucial role in reducing cost for developing biosimilars.
By Anurag S. Rathore, Narendra Chirmule, and Himanshu Malani
Drug development is …
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The Evolving Role of Starting Materials in Cell and Gene Therapy
In 2018, FDA’s Center for Drug Evaluation and Research (CDER) issued a record-breaking 59 new drug approvals (3). Of these new approvals, 32% were authorized as first-in-class, and 58% were approved t…
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Driving Improved Access to Biosimilars
In a formal statement in December 2018 (2), former FDA commissioner Scott Gottlieb referred to insulin prices, which have increased nearly 600% between 2001 and 2015, with the average US list price ri…
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Emerging Therapies Test Existing Bioanalytical Methods
The May 2018 FDA Bioanalytical Method Validation (BMV) Guidance for Industry (2) provides general guidelines for all bioanalytical assays but lacks any specifics on assays that use flow cytometry, PCR…