Search results for " clinical trials"
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Vaccine Development and Production Challenges Manufacturers
To ensure supplies for clinical trials and anticipated commercialization, the Biomedical Advanced Research and Development Authority (BARDA) in HHS is working with vaccine makers to validate and optim…
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Making the Move to Continuous Chromatography
…sing should be balanced with the risk of delayed regulatory process applications and thereby time to clinical trials and market introduction. “Even though regulatory agencies are very supportive and …
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Patenting Prospects for Cell-Based Therapies
Many groups worldwide are developing cell-based therapies for a variety of diseases; most of those (87%) in clinical trials are being conducted in Phase I or II. Half of such trials are in the US with…
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Vaccine Development Faces Urgency and Challenges
Merck announced advanced clinical trials for its vaccine developed with NewLink Genetics in January 2016, plus a deal with GAVI, the Vaccine Alliance, for coverage and distribution by the end of 2017 …
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What is process development?
Ultimately, you will need a process that translates to a manufacturing environment, one that is easy to scale up throughout clinical trials and to the market. By the time you reach Phase III in the dr…
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Late stage failures of monoclonal antibodies
In this article, the authors showcase some of the monoclonal antibody (mAb) candidates that reached Phase III clinical trials but were discontinued at later stages.
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Scaling Up Novel Therapies
The company received “breakthrough therapy” status for retinal dystrophy and hemophilia treatments, and is collaborating with Pfizer on hemophilia therapies, now in Stage III clinical trials.
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FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
More consistent and reliable production processes are critical for advancing innovative treatments.
By Jill Wechsler
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Understanding Validation and Technical Transfer, Part I
Formulations to be used in clinical trials must be developed. The clinical formulations must be scalable to commercial production, retaining their effectiveness and safety attributes. Commercial produ…
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Modern Manufacturing Key to More Effective Vaccines
Test vaccines also may be used prior to obtaining real-time stability data, especially for early clinical trials.
An accelerated pathway for vaccine testing, however, “puts the squeeze on the …