Newsletter | January 25, 2023

01.25.23 -- FDA Adopts ICH Final Guidance On Bioanalytical Method Validation

New Podcast Episode
Featured Editorial
Industry Insights
Gamma Irradiation: Risk-Based Approach To Sterility In Single-Use Systems

Understand the difference between a validated sterile claim and a low or zero bioburden microbial control claim on single-use systems and where each fits into biopharmaceutical manufacturing processes.

Transitioning From Vial To Prefilled Syringe

Understand how formulation development for a prefilled syringe affects manufacturing, driving the industry toward optimizing delivery of injectable products and, ultimately, improving patient care.

Manufacturing Of Sterile Aqueous Suspensions: A Primer

Sterile suspensions are particularly difficult to manufacture. This technical article covers factors for success, including particle size, vehicle formulation, and considerations for high-shear mixing. 

N-Linked Glycan Analysis For Complex Glycoproteins

An established cell line and a bench-scale manufacturing process for a complex glycoprotein produced high-quality material but had a low yield and was not scalable.

A Guide To Finding The Right Cell Culture Media For Your Bioprocesses

We discuss the challenges and opportunities when developing a media approach and explore the benefits of partnering with a provider with expertise throughout the media pipeline.

The Path To Confidence At Every Point Of Connection

Practical information on key issues including extractable/leachable testing in components, freeze/thaw in single-use assemblies, efficiencies driven by SUT advances such as genderless connectors, and more.

Resin Sourcing

Learn about regulatory pathways for introducing biopharmaceutical process improvements and/or alternate sources of chromatography resins.

Optimizing Lipid Formulations For Targeted RNA-LNP Applications

Learn about the considerations and challenges of using ionizable lipids, including the five types of lipids used for RNA delivery.

High-Throughput mAb Purification With Fibro Chromatography

Rapid cycling, using Fibro PrismA units together with an ÄKTA pure™ system and an autosampler, offers new opportunities in high-throughput purification for screening of lead candidates and process conditions.

Exosome Research Products Version 2 Guidebook

Exosomes have recently been attracting research interest. This guidebook is a useful resource for exosome researchers seeking high-purity isolation.

Embrace Molecule Complexity With Optimized Expression Technologies

Explore the needs of more complex candidates through case studies that demonstrate the range of expression capabilities across mammalian and microbial-derived molecules.

Components Of An Effective Disinfectant Prequalification Strategy

Cleaning procedures designed specifically to destroy microbial contaminants that may be present are an important component of any microbial control strategy.

Systems For Shop Floor Automation And Digitization

We review an automation system that is based on a standard technology platform, with standardized hardware, networking, and software elements and designed to securely connect to end-user networks.

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