Search results for " CDMO"
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A Plastic Pipeline for Commercial Bioprocessing?
“For a CDMO whose goal is to fill the plant with products, gaining this type of changeover time is critical for them. They can sell this to their customers because they can fill their plant in an effi…
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Good Manufacturing Practices: Challenges with Compliance
…quality, Catalent; Judy Cohen, vice-president of Quality and Regulatory at Lubrizol Life Science’s CDMO Division; and Dino Muzzin, senior vice-president of manufacturing operations at Emergent BioSol…
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Gene Therapies Push Viral Vector Production
Vicaire states that a combination of structural evolution on the CDMO side and development of new technical solutions on equipment suppliers’ side can solve production challenges. “We must bring robus…
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Taking a “Development-by-Design” Approach to Cell Therapies
More CDMOs are entering cell therapy market niche
Demand for specialized cell therapy manufacturing and development services is also growing, and has attracted Lonza Bioservices, Cognate BioServic…
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Q&A with Eric Langer, about the evolution of the role of CMO’s in Bioprocessing
But more and more are taking on development tasks, so they can provide a broader scope of services; they’re moving into the CDMO’s model. An upside to this model is that many breakthrough biologics an…
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Regulatory Requirements for Safe and Efficient Biologic Drug Development
Especially if you're going to a CDMO, make sure you have all the requisite information that the company needs to actually start manufacturing that product.
With that said, sometimes all the inf…
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Updating Viral Clearance for New Biologic Modalities
In the end, the greatest challenge for manufacturers, CDMOs, and vendors alike is the sheer diversity of biopharmaceuticals being developed throughout the world today. It’s “awe-inspiring,” Berrie say…
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Technology Innovations Improve Process Chromatography Performance
As technology matures, inefficiencies and process limitations in downstream process chromatography are improved.
By Feliza Mirasol
Selecting an appropriate separation technology fo…
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Mapping a Route for Cell and Gene Therapy Process Development
“Many CDMOs are now integrating sufficiently flexible production workflows by utilizing automated systems. This approach can potentially enhance process and product standardization, provide effective …
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Industry Adoption of Single-Use Systems Remains Low
Abzena, a CDMO, conducts development and GMP manufacture of antibody drug conjugates at its Bristol facility and conducts development and GMP manufacture of monoclonal antibodies and other recombinant…