Search results for " facility" in Articles / App Notes
Article
Ensuring Viral Safety of Viral Vaccines and Vectors
Ensuring Viral Safety of Viral Vaccines and Vectors
Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.
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Optimizing Late-Stage and Commercial Cell-Culture Processes
… increasing titers, maintaining consistent product quality, reduced cost of goods, and a decrease in facility footprints, Laird says.
Cell-culture hurdles
The ability to maintain a reliable s…
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Biopharma Seeks Balance
Biopharma Seeks Balance
Biopharma companies can balance competing demands from patients, investors, and regulators by keeping a focus on science.
By Rita C. Peters
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Article
Understanding Validation and Technical Transfer, Part 2
Understanding Validation and Technical Transfer, Part 2
A validation plan developed to support a process unrelated to bio-pharmaceutical manufacture is applied to biopharmaceutical processes and sys…
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CDMOs Driving Emerging Bio/Pharma Success
CDMOs Driving Emerging Bio/Pharma Success
CDMOs can claim credit for the robust growth of emerging bio/pharma financings.
By Jim Miller
Emerging bio/pharmaceutical companie…
Article
Putting Viral Clearance Capabilities to the Test
“The impact on the validity of the viral clearance data by changes to the process, such as facility, procedural, process, and raw materials must be assessed,” says Smith. “A detailed risk assessment c…
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Going Viral
… therapies allows manufacturers to quickly build a ready-to-run, prefabricated modular manufacturing facility for these therapies, and then rapidly add production capacity to meet demand.
Learn …
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Modern Manufacturing Key to More Effective Vaccines
Modern Manufacturing Key to More Effective Vaccines
Accelerated development of new preventives raises challenges for efficient CMC evaluation and production.
By Jill Wechsler
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Single-Use Chromatography: Adapting to Manufacturing Scale
Single-use technologies offer the flexibility needed to meet the demands of multiproduct facilities. The capital investment is lower, and substantial time savings can be made when eliminating cleani…
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Applying GMPs in Stages of Development
…methods, level of detail needed in batch records, level of control needed on incoming materials, and facility and equipment controls. An example is qualifying raw materials. In Phase I/II of the deve…