Newsletter | June 5, 2024

06.05.24 -- Can ICH Q14 Ease Regulatory Risks Around Impurity And Potency Testing?

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Evaluation of Lentiviral Vector Stability and Development

For process-scale purification, achieving purity while maintaining the stability of lentiviral vectors (LVVs) is a challenge. Ion exchange chromatography (IEX) is effective for LVV purification, and a strong anion exchange resin offers high flow rates, easy scale-up, and high binding capacity, ensuring efficient purification even at large scales. Discover key findings that highlight the importance of evaluating LVV stability to develop a robust purification process in this app note.

FOCUS ON DOWNSTREAM MANUFACTURING

Can ICH Q14 Ease Regulatory Risks Around Impurity And Potency Testing?

By Laura I. Salazar-Fontana, Ph.D., and Daniela Drago, Ph.D., RAC, NDA Partners

Variability is inherent to biologics manufacturing. The trick is to catch it quickly and prevent product quality drift. That’s where the new ICH Q14 comes in.

5 Types Of Formulation Excipients And How They Impact Biologics Stability

Article | By Stefanie Kall, NanoTemper Technologies, Inc.

Review how different excipient classes stabilize biologics in unique ways and why they are important to consider even in the early preformulation stage of buffer optimization.

Key Considerations To Optimize Downstream Process Development For mAbs

Article | EirGenix Inc.

Optimizing downstream process development for mAbs requires scientific expertise, careful planning, and rigorous testing. Delve into the essential steps and learn how to deliver high-quality mAbs.

Bridging Anti-E. coli HCP Antibodies And E. coli Antigens

Application Note | By Jared Isaac, Bryan Lanning, et al., Cygnus Technologies Inc.

Read this expert comparative coverage analysis study performed to assess the reactivity of anti-E. coli HCP antibodies that support ELISA kits.

How To Develop An Efficient Downstream Purification Process For bsAbs

Webinar | Cytiva

Bispecific antibodies (bsAbs) have gained increasing interest in recent years. Learn how to develop an efficient downstream purification process for a cancer immunotherapy bsAb.

Achieve Downstream Process Improvements Through Buffer Management

White Paper | By Pranav Vengsarkar, Avantor

Understanding the alternative buffer management and preparation strategies available can ensure you have the tools and resources to remain competitive in today’s growing bioprocessing industry.

Why You Need Monoliths To Purify Your Biomolecules

Webinar | Sartorius

What makes monoliths the ideal solution to the challenges of purifying large biomolecules and how do they remove critical bottlenecks for the downstream purification of new modalities?

Reduce The Environmental Footprint Of Oligonucleotides

Q&A | Ajinomoto Bio-Pharma Services

Yuki Shinohara from Ajinomoto Bio-Pharma Services answers attendee questions from a recent webinar about sustainability concerns surrounding oligonucleotide manufacturing.

Achieving Optimal Purity And Recovery Of Monoclonal Antibodies

Article | Bio-Rad Laboratories, Inc.

Learn about two resins that can be used in chromatography and purification processes to optimize your mAb yields.

DOWNSTREAM MANUFACTURING SOLUTIONS

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A Bench-Top Chromatography System To Simplify Everyday Operations - Cytiva

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Immediate Availability On All Protein A Resins - Purolite, An Ecolab Company

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