Search results for " quality"
Article
A Q&A With Parrish Galliher About Adopting Single-Use Systems
Agencies are giving the go-ahead and recognize the benefits for a manufacturing quality control perspective. In addition to Shire HGT in the U.S., there are commercial plants now licensed or going com…
Article
Biopharma Moves to Integrated, Single-Use, Downstream Processing
On the smaller scale, Masser also notes that scrutiny by FDA and internal quality control becomes more intense the closer a process step is to the final therapeutic, and as a result there have histori…
Article
Gowning Practices Provide Clues to cGMP Compliance
The foundation of any successful quality-assurance system is strict adherence to good manufacturing practices (GMPs). Quality must be built into the design of a facility to ensure that drugs are manuf…
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Q&As with Industry Leaders
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Cell Culture Media Considerations and Optimization for Improved Titers and Protein Quality
Peggy Lio, Senior Director of Global Cell Culture Services at Cytiva
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Q&A with Industry Leader Konstantin Konstantinov, Genzyme Vice-President
Furthermore, continuous processing facilitates quality control. For instance, many therapeutic proteins are insufficiently stable for batch processing. But with continuous processing, once the protein…
Article
Monoclonal Antibodies Key to Unlocking the Biosimilars Market
It is the job of the biosimilar sponsor to demonstrate that the differences result in no clinically meaningful effect on quality, safety, or efficacy compared to that of the innovator drug.
A clea…
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FDA and EMA Extend QbD Parallel-Assessment Pilot Program
…onal guidelines related to QbD and promote the availability of pharmaceutical products of consistent quality throughout the European Union and the United States.
The extension follows what FDA and…
Article
Comparing Protein A Resins for Monoclonal Antibody Purification
The lifetime study with mAb-containing feedstock demonstrates that the product quality, DBC, and yield with Resin 3 were stable for more than 100 purification cycles. No increase in pressure was obser…
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Evolution of the Monoclonal Antibody Purification Platform
Table I summarizes some of the process development challenges with mAb quality from the various expression systems and the tools and unit operations options for addressing these challenges.
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Article
Trends in Downstream Bioprocessing
…cost-effective biosimilar manufacturing, as well as reduced overall bioprocessing costs at GMP level quality.
References
1. BioPlan Associates, “2013 Biotechnology Industry Council Trends Ana…