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May 19, 2021
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  Recent Advances of Chemical Definition of Cell Culture Media and Excipients for Virus and Viral Vector Manufacturing

Virus production is a critical step in cell and gene therapies and vaccine manufacture. Due to supply chain constraints, poor reproducibility, and safety concerns attributed to potential adventitious agents present in serum and serum-derived proteins, regulatory agencies have encouraged replacement of these components. Recombinant albumin and transferrin can successfully replace serum-derived proteins these applications. Furthermore, recent successes have demonstrated that recombinant human serum albumin can serve as an effective excipient in final formulations for the stabilization of virus in vaccines.

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» Industry News
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  US Supreme Court Denies Sandoz Petition to Review Biosimilar Erelzi® Case
Sandoz has announced that the US Supreme Court has denied its petition to review the Federal Circuit... read more »
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  MilliporeSigma Announces VectorY as Winner of its Advance Biotech Grant
MilliporeSigma announced that VectorY has been selected as the European winner of its 2021 Advance ... read more »
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  Agenus and BMS Announce License for Anti-TIGIT Bispecific Antibody Program
Bristol-Myers Squibb Company and Agenus Inc. have entered into a definitive agreement under which ... read more »

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» Infographic
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  Top 5 Things to Know About the USP <643> Changes
The United States Pharmacopeia (USP) specifies regulations for pharmaceutical manufacturing to ensure safe and effective drug products. USP <643> Total ... read more »
» Featured Articles
Validation of Bacterial Endotoxins Testing Platforms
Validation. This one word can invoke a series of feelings in any lab. It might invoke a feeling of fear or uneasiness because the process can be time-... read more »
Continuous Manufacturing Process Development from Lab to Market, Role of Digital Tools
The continuous manufacturing of pharmaceutical compounds and fine chemicals is in high interest for the industry due to significant technical, quality... read more »
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» Featured Video
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  On-Demand Webinar: Development and Validation of a Robust Commercial Solution for Measuring Residual Kanamycin-Resistant Plasmid DNA
In this webinar you’ll learn: overview of current regulatory requirements for residual DNA clearance for biological products including residual ... watch »
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  On-Demand Webinar: High-Purity Albumin Improves Biopharmaceutical Formulations and Performance
In this webinar you’ll learn: optimizing final formulation of drug products with albumin; how to avoid the variable nature of albumin’s structure, how... watch »

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» Featured Whitepaper
eBook: Focus On Drug Development: Solutions to Product Formulation and Development Challenges
eBook covers a wide variety of topics that focus on some of the most difficult product formulation and development challenges. Articles present solutions to working with many of the most ... read more »

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