Search results for " validation" in Articles / App Notes
Article
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 …
Article
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 …
Article
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…
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Unifying Continuous Biomanufacturing Operations
The success of a truly integrated continuous processing platform relies on the collaborative efforts of upstream and downstream specialists.
By Randi Hernandez
When human cells travel throug…
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Improvements in Protein A Chromatography
In addition, it would likely lead to the development and validation of a Protein A resin storage procedure for use during plant shutdown. This effort is often justifiable only after mAb licensure and …
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Defining Risk Assessment of Aseptic Processes
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.
By Susan J. Schniepp
Q: I work in …
Article
Real Time Continuous Microbiological Monitoring
Therefore, both CFU-based plate count monitoring and bio counts monitoring should run in parallel for microbial monitoring (at least through validation and implementation).
Any change in env…