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Alleviating viral safety challenges in biologic manufacturing

Join us On-Demand for this webinar sponsored by Avantor reviewing the results of an extensive VC study with different model viruses, demonstrating the DVI’s capabilities. Learn more now!

Now Available On-Demand
Originally Broadcasted: October 4, 2023

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Summary

To ensure product and patient safety, global regulatory guidance requires adequate viral clearance (VC) in the biologics manufacturing process, especially for biotherapeutics derived from mammalian cell culture or animal origin. An orthogonal approach for VC is the detergent-mediated viral inactivation (DVI) for various drug modalities, such as mAbs, plasma-derived products and AAV. Though Triton X-100 has been a preferred detergent for the DVI technique, recently the European Chemicals Agency under REACH regulations has placed Triton X-100 on its list of substances of very high concern. Therefore, a paradigm shift in the industry is to explore biodegradable alternatives that comply with regulatory requirements. In this presentation, we will discuss the importance and application of a DVI approach for viral safety using a regulatory compliant, biodegradable, non-ionic detergent.  

This presentation covers the results of an extensive VC study with different model viruses, demonstrating the DVI’s capability to:

·      achieve >6.5 LRV and high virus killing kinetics, independent of temperatures (4⁰C to RT)

·       have no impact on the stability of structurally diverse antibodies and process performance

·       easily be cleared by subsequent purification steps and detected using a simple analytical technique

 In parallel, a thorough VC study has also been performed for a novel high-capacity protein A resin. The highly efficient protein A resin was able to provide 4.65 LRV for retrovirus. In this webinar, we will show how the effective combination of a biodegradable detergent treatment and an efficient protein A chromatography resulted in >11.0 log of viral clearance.

Sponsored by:

Speaker

Tuhidul Islam, PhD
Senior Manager, R&D Engineering, Bioprocess Applications

Tuhidul Islam joined to Avantor in September 2021 and is Sr. Manager - Bioprocess Application at Avantor Technology & Innovation (T&I). He is focused on applications of new product and processes to overcome challenges in biologics manufacturing for multiple therapeutic areas. Prior to joining Avantor, Tuhidul worked as a process development manager at Thermo Fisher Scientific, in designing and developing of downstream processes for different biologics drug modalities, scaling-up and technology transfer to cGMP. He also worked at AGC Biologics for late-stage process development. Tuhidul holds a PhD degree in Biochemical Engineering from Jacobs University, Germany, with a particular focus on protein purification method development, and spent several years as a postdoctoral researcher at BTEC, NC State University, USA. These experiences afforded him to learn various aspects of process development and manufacturing sciences of monoclonal antibodies, fusion proteins, Adeno-associated virus and Lentivirus.

Moderator

Andrea Corona | Senior Editor | Pharma Manufacturing