---
title: "Manufacturing a Recombinant Retrovirus: Downstream Purification Process Development through GMP Implementation"
description: This webinar will detail the importance of resin screening, endonuclease treatment, process development, and the scale-up purification of a retrovirus-like particle intended for use in human subjects.
---

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# Manufacturing a Recombinant Retrovirus: Downstream Purification Process Development through GMP Implementation

Please join us for this free, live Ask the Expert webcast.

Just fill out the form below to register.

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## Presenters:

****![MarkFitchmun](https://bpi.bioprocessintl.com/hs-fs/hubfs/MarkFitchmun.png?width=150&name=MarkFitchmun.png)****

**Mark Fitchmun**  
President and CEO  
Somatek, Inc.

 

Since founding Somatek in 2002, Mr. Fitchmun has contributed to the development of over 45 biopharmaceuticals, including therapeutic antibodies, antibody-drug conjugates, fusion proteins, viruses, and clinical diagnostics. He has expertise in risk-based strategies for product development in the biologics space. His core strengths are in bioprocess development and analytical method development where he has published manuscripts and holds several patents. Mr. Fitchmun has served as Vice President at Accelagen; Vice President, CMC, at Cold Genesys; Vice President, Manufacturing, at AlphaEleven; and Manager of Process Development at GenStar.

 

## About this event:

#### Date: April 13, 2021

#### Time: 11 am EDT | 8 am PDT | 5 pm CEST

#### Duration: 15 minutes

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Purification of enveloped viruses and virus-like particles presents several challenges due to their large size and complexity. In this webinar, a case study will be presented and will detail the importance of resin screening, endonuclease treatment, process development, and the scale-up purification of a retrovirus-like particle intended for use in human subjects. The resulting current good manufacturing practice (CGMP) compatible process required approximately four hours to purify 240 L of nuclease-treated bioreactor harvest and resulted in a 99% reduction in process volume and up to 65% recovery of virus particles with a final purity consistent with requirements for clinical trials. This process is readily scalable, fast, low cost, simple, and CGMP compatible and can be used for the capture step in clinical-grade manufacture of retrovirus vectors.

Webcast Overview

- Introducing retrovirus vectors and associated analytical methods
- Discussing scale-down modeling
- Establishing chromatographic parameters
- Examining process scale-up execution and evaluation

 

This presentation is sponsored by Bio-Rad.

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