Search results for "validation"

Article Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
To be successful, however, the lead partner will need an understanding of biomanufacturing facility design, engineering, qualification, and validation, as well as the operational aspects of combining …

Article Viral Clearance Challenges in Bioprocessing
Process representation Another challenge for viral clearance validation is accurate process representation. “In order to perform high-quality viral clearance studies and avoid unreliable, inaccurat…

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…

Article 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…

Article 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…

Article 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 …

Article 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…

Article 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…

Article 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…

Article 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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