Search results for " cell"
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CDMOs Driving Emerging Bio/Pharma Success
… antibodies being augmented by highly potent small molecules, antibody drug conjugates, and gene and cell therapies
• A favorable regulatory environment that offers faster routes to new drug a…
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Optimization of Adenovirus Midstream Purification Steps
Adenovirus (AdV)-based vectors are widely evaluated as vaccine delivery system in preclinical and clinical studies for various infectious diseases. In this application note, studies of midstream pur…
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Achieving Efficient Adenovirus Upstream Production
This application note describes the production of adenovirus in HEK293 suspension cells in a bioreactor system. Triplicate cultures demonstrate a reproducible and robust batch production of adenovirus…
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Biopharma Says It Has an Evolution in New Technologies and Processes
Q: How are equipment and materials suppliers meeting the demand for emerging drug therapies?
A: FDA’s approval in 2017 of cell- and gene-therapies created a great deal of excitement in the industr…
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Making the Move to Continuous Chromatography
“With the ability to operate at higher titers or cell densities, there is a drive to reduce bioreactor volume. If a manufacturer can reduce its process to a 2000-L bioreactor, or multiple 2000-L biore…
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Understanding Validation and Technical Transfer, Part I
Process validation is documented process understanding and control that begins when it is determined that a cell, molecule, or compound may have clinical significance and ends when the product is no l…
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Modern Manufacturing Key to More Effective Vaccines
This coincides with efforts to shift from egg-based to cell-based and recombinant DNA production technologies. In commenting on the effectiveness of this year’s flu vaccine, Gottlieb noted that produc…
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Exotoxin Clearance from mAb Samples in a Two-Step Chromatography Process
A heat-stable exotoxin can remain as a contaminant of a drug substance throughout the whole manufacturing process, with the risk of adversely affecting patients’ health. One such toxin is cereulide …
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Process Development: What May Lie Ahead in 2018?
In addition to the 46 new drugs approved by FDA’s Center for Drug Evaluation and Research, the agency’s Center for Biologics Evaluation and Research approved two cell-based chimeric antigen receptor (…
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Transformative Medicines Challenge FDA and Manufacturers
… is monitoring more than 600 active investigational new drug applications (INDs) related to gene and cellular therapies.
Biopharma researchers also are achieving success in developing oligonuc…