American Pharmaceutical News In Review

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November 03, 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.

	Industry News

Oncopeptides Withdraws Pepaxto® in US, Scale Down Organization and Focus on R&D
Oncopeptides AB, a global biotech company focused on the development of therapies for difficult-to-... read more »

CDC Unanimously Recommends Johnson & Johnson COVID-19 Vaccine as a Booster for All Eligible Individuals Who Receive Authorized COVID-19 Vaccines
Johnson & Johnson announced that the U.S. Centers for Disease Control and Prevention (CDC) Advisory ... read more »

Pfizer and BioNTech Announce Phase 3 Trial Data Showing High Efficacy of a Booster Dose of Their COVID-19 Vaccine
Pfizer and BioNTech announced topline results from a Phase 3 randomized, controlled trial evaluating... read more »

FDA Selects Aetion Evidence Platform® to Advance Regulatory Science and Innovation
Aetion announced the expanding its relationship with the FDA to use real-world evidence (RWE) to ... read more »

	Infographic

The Top 4 Considerations in Lyophilized Product Development
To eliminate the concern of parenteral pharmaceuticals becoming unstable over time, lyophilization, or freeze-drying, is used to remove the water from... read more »

	Featured Articles

Identification of Recovered Environmental Microbial Isolates Besides detecting and enumerating the number of microorganisms in an environmental test sample (i.e., air, compressed air, purified water and ... read more »

Pharmaceutical P.I.N. Points Patent Innovation News The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Office in June-July ... read more »

	Featured Video

On-Demand Webinar: Unified Particle Analysis by Raman and Infrared Microscopy
In this webinar you’ll learn: Identification of unknown particles in a wide variety of manufacturing processes. Reverse engineering and failure ... watch »

	Featured Products

Nano DSC Complete Autosampler System v2
read more »

	Featured Whitepaper

App Note: Study of Protein Conformation with FT-IR
The principle and application range of this technique in the field of protein biochemistry will be examined. Infrared light excites molecules to vibrate. Those molecules absorb only light of certain... read more »

	Events

Ophthalmic Drugs Conference
London, UK – 11/22/2021
The global ophthalmic drug market is forecast to surpass $60 billion USD by 2025 with increasing focus from the industry on alternative delivery ... event details »

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