Newsletter | March 2, 2023

03.02.23 -- 6 Strategies To Protect Your Biologics Supply Chain In 2023
 
Featured Editorial
6 Strategies To Protect Your Biologics Supply Chain In 2023
 
By Alexander K. Aust, M.S., MBA, Aust Business Solutions

Instead of automating everything — which costs a lot and doesn't solve every problem — drugmakers should focus on building scalable, need-specific supply chain operations. This article discusses supply chain resilience strategies biotech companies can reasonably control.
Considerations For Microbial Enumeration Methods When Working With CDMOs
 
By Miriam Guest, principal microbiologist, AstraZeneca

In microbial enumeration testing, the product-specific interferences are addressed during method development. The execution can vary between laboratories. This article examines general considerations, membrane filtration, and the pour plate method.
Industry Insights
Alternatives To In Vivo Assays For Biosafety Testing Of Biologics
White Paper | MilliporeSigma

Even as alternative methods such as PCR and NGS have emerged, in vivo tests have stubbornly remained a central part of testing. Here we examine current in vivo methods and explore modern alternatives.
Better Biotherapeutic Characterization For Improved Quality Control
Poster | Cytiva
Critical quality attributes (CQAs) are fundamental to regulatory compliance and typically include data on how the candidate interacts with target proteins, size, and purity. In addition, information on process-related CQAs such as protein integrity, homogeneity, presence of host cell proteins, and DNA are required. This poster booklet provides a snapshot on how different analytical technologies have been used to investigate aspects related to the efficacy, stability, and safety of therapeutic candidates.
News Headlines
Solutions
BD Libertas Wearable Injector
BD Medical - Pharmaceutical Systems
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