Search results for " meeting"
Article
Viral Clearance Challenges in Bioprocessing
“Comprehensive test design resulting from thorough process understanding and communication between the biologics manufacturer and the virus clearance testing lab is essential to meeting these goals.”
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Article
Continued Process Verification for Biopharma Manufacturing
From presentation at 10th APIC/CEFIC meeting, “FDA’s Quality Initiatives—An Update” by Moheb M. Nasr
About the Authors
Jeff Fleming is an independent writer with over 30 years of experience in…
Article
Manufacturers Struggle with Breakthrough Drug Development
Accelerated testing and production create challenges in documenting product quality.
Biopharmaceutical companies are eager for FDA to designate potential test therapies as “breakthrough drugs…
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Determining Criticality, Part Two: DoE and Data-Driven Criticality
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle.
T…
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Best Practices in Adopting Single-Use Systems
Key considerations for implementing single-use components or platforms when moving from research to process development.
The adoption of single-use systems in biopharmaceutical production or…
Article
Operational Excellence: More Than Just Process Improvement
Due to the importance of the manufacturer’s vaccines to public health, the agency required biweekly meetings with the company for progress reports. Just three months into the program, the company was …
Article
Essentials in Establishing and Using Design Space
Chatterjee, “Design Space Considerations,” FDA, AAPS Annual Meeting, October 14, 2012, Chicago, ONDQA/CDER/FDA.
4. ICH, Q9 Quality Risk Management (2006).
About the author
Thomas A. Little…
Article
Sterilization Trends for Single-Use Consumables
Typically, meeting a minimum 10-6 sterility assurance level with a dose that does not exceed an established value so as not to adversely impact or meaningfully degrade the materials is involved.
T…
Webcast
Establishing a CHO-K1 cell line and cell line development process for biotherapeutics markets
…nd regulatory scrutiny?
Join Cytiva’s webinar on February 1 to explore key strategies for meeting current industry standards in the shortest amount of time feasible.
Article
Webinar: Establishing a CHO-K1 cell line and cell line development process for biotherapeutics markets
… and regulatory scrutiny?
Join Cytiva’s webinar on February 1 to explore key strategies for meeting current industry standards in the shortest amount of time feasible.
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