Search results for " approval"
Poster
Opportunities, Challenges, and Economic Drivers for Start-to-Finish Continuous Biomanufacturing
Continuous unit operations have been used successfully in manufacturing of several approved products with a collective revenue of $25 billion annually. Many large biopharmaceutical organizations are…
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Scalable Viral Vector Manufacturing
The interest for robust and scalable viral vector manufacturing is rapidly increasing, with the recent developments of both cell and gene therapy and oncolytic virus-based therapies. As cost pressur…
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Scaling Up Novel Therapies
Scaling Up Novel Therapies
Platform processes have improved monoclonal antibody scale-up. Can they do the same for personalized therapies?
By Agnes S…
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The Challenge of Disruptive Technologies in Bioprocessing
The move is meant to meet market demand for gene therapies, which are progressing in the clinic toward approval and commercialization.
The increase in more challenging molecules under developme…
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Understanding Validation and Technical Transfer, Part 2
Understanding Validation and Technical Transfer, Part 2
A validation plan developed to support a process unrelated to bio-pharmaceutical manufacture is applied to biopharmaceutical processes and sys…
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Putting Viral Clearance Capabilities to the Test
When applying for regulatory approval, a drug license holder must demonstrate that its proposed manufacturing process can remove or inactivate potential viral contaminants.
Viral clearance studies…
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Get Acquainted with How SPR Technology is Used for Better Protein Characterization
Surface plasmon resonance (SPR) has become a go-to tool for biotherapeutic characterization, and most approved antibody therapeutics have passed through a Biacore SPR system.
Stay up-to-date wit…
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Making the Move to Continuous Chromatography
Making the Move to Continuous Chromatography
Early adopters are benefiting from lower costs and increased productivity.
By Cynthia A. Challener
Tashatuvango/Shu…
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Tools and Solutions for Separation of Charged mAb Variants
To attain regulatory approval, a comparable quality to the reference product in terms of efficacy, purity, and safety should be demonstrated. Biomolecules, however, exhibit high structural complexity …
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3rd BioProcessing Asia Preview: Q&A with John Curling
Given approvals of gene and cell therapy treatments in 2016-2017 and recent reports of positive clinical trial outcomes for the AAV-FVIII gene therapy treatment of Hemophilia A, I believe that develop…