Search results for " meeting" in Articles / App Notes
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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…
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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 …
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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…
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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…
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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.
LEARN MORE >>
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Pandemic Alters Policies and Practices for Drug Development and Regulation
Regulatory flexibility
In addition to remote field inspections, FDA review staff organized virtual meetings with medical product sponsors to assess and devise appropriate, yet more flexible R&D …
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Maximum Output Starts with Optimized Upstream Processing
By Cynthia A. Challener
Biopharmaceutical companies and contract manufacturers respond to changing demand dynamics for upstream bioprocessing capacity.
Significant growth in the develo…
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Assessing Manufacturing Process Robustness
A structured assessment process can determine compliance to lifecycle process-validation requirements for biopharmaceuticals.
By: Ajay Pazhayattil, Sanjay Sharma, Amol Galande, Marzen…