Search results for " validation" in Articles / App Notes
Article
Manufacturers Struggle with Breakthrough Drug Development
The plan should consider how estimated market demand would relate to manufacturing facilities, lifecycle process, methods validation, and stability studies. Early submission of CMC information will al…
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Strategizing for Rapid Changeovers in Biologics Manufacturing
Stainless-steel equipment specifically presents a common challenge, as it requires cleaning and validation of product contact surfaces before the equipment can be used for a subsequent project, accord…
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Biopharmaceutical Process Development: 2018 Lessons and 2019 Predictions
Understanding the Regulatory Environment
Regulatory-focused articles were the most popular 2018 posts on the Process Development Forum, with validation and tech transfer being especially importa…
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Trends in Single-use Bioreactors
The same change in a conventional stainless steel operation may require an extensive re-work of facility infrastructure, and may require an additional investment or facility validation.
Sherman …
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Discovering the unknown: How does in silico process development change PD scientists’ work?
And using the generated process understanding to define robust process operating ranges to mitigate risk is a great tool to be applied in process characterization and validation studies, and can be us…
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Digitalization: The Route to Biopharma 4.0
Scientific knowledge comprises process development and validation, whereas technical know-how involves process definition and scale-up for commercial production. Multiple organizations need to collabo…
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Implementing Inline Conditioning to Advance Process Intensification
After we received the equipment on our site, we performed a feasibility study, followed by a validation study and finally, we ran an engineering batch.
We then moved to use the technology in GMP b…
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Reducing Cross-Contamination Risks in Process Chromatography
“With typical bioprocessing tools, a lot of effort and care goes into cleaning and cleaning validation of contact surfaces since any contamination in the purification process can be detrimental to the…
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Microbiological Testing: Time is of the Essence
“The prevailing concern is that these alternative methods require extensive validation studies to demonstrate equivalency to traditional microbiological methods. The need for such extensive method val…
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Selecting the Right Viral Clearance Technology
“An inadequate understanding of the clearance requirements can result in failure to hit the needed clearance targets and the need for additional validation studies or viral clearance steps. Alternativ…