Search results for "biologic"
Article
Challenges of Protein Aggregation During Purification
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Removal of protein aggregates from biologic APIs is crucial due to their potential to increase immunogenicity. While most aggregates are formed during upstream operations, and the risk for …
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Q&A with Industry Leaders: Rita Peters
… educational sessions and new product introductions revealed a recurring theme: a stronger focus on biologic drug research and development versus small-molecule development.
At Pittcon 2014, the …
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HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
Q6B, Specifications: test procedures and acceptance criteria for biotechnological/biological products. Geneva, Switzerland; 1999.
4. US Food and Drug Administration. Guidance for industry. Points …
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Advancing QbD in the EU
The biggest change in the GMP guide is a massive extension of Annex 2 on the manufacture of biological active substances, which has been extended from five to 32 pages and from 43 sub-items to 70.
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The Future of Biopharma
Some of the biopharmaceutical trends coming in 2013 support a future vision that includes:
• increasing number of global biopharma facilities
• more biological products, many with smaller nich…
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Addressing the Challenges in Downstream Processing Today and Tomorrow
Most commercial prophylactic vaccines are not well-characterized biologicals from a regulatory perspective because of their inherent complexity and/or poorly understood mechanism of action. In additio…
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Pushing the Barriers in Next-Gen Antibody Development
Continued development of new and next-generation antibodies is spurred by the increasing demand for more effective and custom-tailored biologic therapies. In particular, bispecific antibodi…
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Genetic Vaccine Platforms Demonstrate Their Potential
Genetic vaccines, while faster to develop than proteins, are still biologic products that require cell culture and sophisticated technology for development and manufacturing at both clinical and comme…
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Manage HCPs and Enhance Your Route to Market
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Host cell protein (HCP) management is critical to biologics development—and getting it wrong could delay your development cycle. Learn how the right HCP strategy can e…
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Biomanufacturing: Demand for Continuous Bioprocessing Increasing
Some of these technologies also support the increasing demand for biologics that may be called for in smaller quantities.
Figure 2 shows the economic commitment decision-makers are focusing on …