Search results for "validation"
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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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A Look into the Future of Biopharmaceutical Quality
A Look into the Future of Biopharmaceutical Quality
Quality experts share insights on what the future may hold regarding regulatory quality requirements for biopharmaceuticals.
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Optimizing Late-Stage and Commercial Cell-Culture Processes
• Modeling and leveraging platform knowledge; extensive platform knowledge is enabling more efficient process validation as one study can support multiple products. A platform culture process also ena…
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Fifteen Years of Progress: Biopharmaceutical Industry Survey Results
Bioprocessing lines/facilities need some downtime, including for switchovers, maintenance, new equipment installation and validation, staff training, and cleaning and sterilization of stainless steel …
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Modern Manufacturing Key to More Effective Vaccines
…exceptions to product characterization and testing procedures, and where certain aspects of process validation could be abbreviated. While FDA licenses only those vaccines supported by adequate and w…
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Single-Use Chromatography: Adapting to Manufacturing Scale
The capital investment is lower, and substantial time savings can be made when eliminating cleaning and cleaning validation procedures. While widely adopted in upstream production processes, what is r…
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Participants explored strategies for analytical method development, assay validation, product characterization, specification setting, and for establishing relevant manufacturing controls for these hi…
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Development and Future of Protein A Chromatography Technology: Q&A with Jonathan Royce, Business Leader Chromatography Resins, Cytiva
This week Process Development Forum talks about Protein A with Jonathan Royce, business leader for Cytiva chromatography resins.
mAb purification platforms are very well established, and …
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Avoiding Investigational Failures and Discrepancies
It should be noted that this investigational process demands the validation of action(s) to eliminate recurrence or proof that a plan of action will effectively address the resolution of an event. An …
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Contract Manufacturing Through the Years
Contract Manufacturing Through the YearsHow has the bio/pharmaceutical contract manufacturing industry evolved over the years and what does the future hoHow has the bio/pharmaceutical contract ma…