Today, bioprocessing is best understood to be about the manufacture of biotherapeutics. That may sound as though bioprocessing deserves a pat on the...
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Regenerative medicine evolved from medical research rather than from drug-development companies, and technologies that worked in clinical settings...
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If you want to “clean up” in the recombinant protein business, you might want to start by sweeping away process-related impurities, specifically, host...
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Article examines the manufacturing challenges involved in the development of viral vector based gene therapies
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Thirty-five years on from the FDA’s approval of a first monoclonal antibody, these biologics account for nearly a fifth of the agency’s new drug...
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In January 2020, the United States Food and Drug Administration (FDA) released several new or updated guidance documents pertaining to human gene...
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Manufacturing Challenges
Despite validation of AAV-vectored gene therapy as an effective treatment modality across multiple disease indications,...
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New and improved platforms for producing viral vectors are emphasizing scalability, customizability, purity, and availability
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Significant advances in the specific targeting of delivery vectors and the increased therapeutic efficacy of such vectors for gene delivery have been...
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Antibody–drug conjugates (ADCs) are an emerging class of targeted therapeutics with the potential to improve the therapeutic index seen with...
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The CHO cell is at its height of technological prominence thanks to its adaptability to various culture conditions and plasticity in the context of...
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