Search results for "FDA"
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Science Focus Fuels Successful Process Development for Startups
… a stem-cell therapy that it took from preclinical development to two Phase II trials in Europe and FDA approval for an investigational new drug (IND). “What we learned while carrying out tech transf…
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Modeling the Degradation of mAb Therapeutics
FDA has approved a number of these antibody drug molecules, which are in various stages of clinical and pre-clinical development. But since the major constituent of the final drug product is protein, …
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The Outlook for CMO Outsourcing in 2019
FDA approved approximately 25 new biopharmaceuticals in 2018 (1), and the number of annual approvals is expected to increase in coming years, as new classes of products receive approvals, particularly…
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A Look into the Future of Biopharmaceutical Quality
A Look into the Future of Biopharmaceutical Quality
Quality experts share insights on what the future may hold regarding regulatory quality requirements for biopharmaceuticals.
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Fifteen Years of Progress: Biopharmaceutical Industry Survey Results
Also, during this period, the number of FDA-approved recombinant therapeutics has increased by approximately 400% (6,7). In 2017, FDA set a record for the number (31 approvals) and percent (93%) of ap…
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Leveraging Data for Better Biopharmaceutical Process Control
IFPAC 2018 already showed this year several talks on MS-based multiple attribute methods (MAM), a new acronym being used by FDA’s Emerging Technology Team (ETT) to name the PAT use of these methods.
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Bioburden Entry Points in Downstream Processing
Anastasia Lolas, former FDA Biologics License Application (BLA) reviewer and inspector focusing on microbiology, shares her expert tips in this blog.
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Roadmap Leads to Innovative Biomanufacturing Strategies
In fact, a ‘regulatory’ sub-team has already been formed, and some informal communication with FDA has begun.
The intention is to keep the agencies informed of the Biomanufacturing Technology Ro…
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Being Thorough When Transferring Technology
Communication and taking the time to develop the process are key to successful transfer and scale up of biologics.
By Susan Haigney
Editor's note: The following is an extended version of the…
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Witnessing Major Growth in Next-Generation Antibodies
In January 2017, FDA granted orphan drug status to the company’s candidate MGD006 (also known as S80880), a DART molecule for the investigational treatment of acute myeloid leukemia.
The company i…