Newsletter | May 13, 2022

05.13.22 -- 5 Ways For Emerging Biotechs To Launch Smarter

 
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Meeting Oligo System Development Challenges Head-On

How a customer-driven equipment developer leverages a longstanding, trusted partnership with a supplier to redefine what is possible in oligonucleotide manufacturing.

End-To-End Thinking During Drug Product Development

In this article, Dr. Kashif Ghaffar, process validation pharmacist at Pfizer’s Freiburg facility, discusses what needs to be considered during product development in preparation for commercial manufacture.

Developing A Disposable Grade-A Aseptic Fill/Finish Isolation System

Flexible film isolation has been used in aseptic processing since the 1970s, but these systems tended to be a composite of stainless-steel chambers and airflow modules with a flexible film user interface. 

Characterization Of Oligos, Related Impurities To Support Development

This technical note describes the identification, relative quantification, and structural confirmation of oligonucleotides and related impurities using molecule profiler software.

Combination Device Regulatory Strategy: Success With The FDA

Breakthrough combination products frequently emerge that provide patients with therapeutics comprising two or more constituents. Read how having an adaptive regulatory strategy is key.

AAV Vector Manufacturing

Due to its therapeutic impact on a wide range of diseases and disorders, adeno-associated virus (AAV) gene therapy is one of the most promising advances in modern medicine.

Prepare For Future Viral Vector Manufacturing

Rethink how we transition from translational clinical centers at smaller scale — using flasks and open systems — toward commercial production and methodologies.

Analysis Of Clean-In-Place (CIP)

There are several challenges to effectively analyzing CIP operations. Seeq tools help create a process model that can be applied across cleaning circuits and amended with circuit-specific data.

Outsourcing Microbial Fermentation To A CMO: Key Considerations

Advances in synthetic biology and genetic engineering have fueled the potential of fermentation-based manufacturing. Here we examine key trends and challenges to the approach.

Development, Manufacture Of Biopharmaceuticals In Microbial Systems

We discuss the trends in new molecular formats, which is one of the current drivers of renewed interest in fermentation technologies, along with some of their challenges. 

CQV Strategies To Optimize Cell Therapy Manufacturing

In this webinar, learn tips from a panel of industry experts for delivering efficient, reliable, GMPcompliant facilities and processes specific to cell therapy.

Scale-Up Of Antibody Production: From Bench To Pilot/Production

Here, we detail techniques for the scale-up of an antibody production workflow using CHO cells and illustrate how novel scale-up assist software supports scale-up strategy design.

Evaluation, Application Of Amsphere A3 In Purification Processes

This webinar reviews the results of comparisons of the Amsphere A3 resin to other high-performance Protein A resins available.

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