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Clarkston Experts Share Guest Column About Mitigation Strategies for mRNA Production

April 17, 2023  |  Clarkston Consulting’s Swati Patel and Michael Lanewala were recently featured as guest columnists with Bioprocess Online (as well as Pharmaceutical Online, Cell&Gene, Outsourced Pharma, and Biosimilar Development) for perspectives on mitigation strategies for mRNA production. Read a few excerpts from the piece below or the full article here.


4 Risk Mitigation Strategies For Procuring Custom Raw Materials For mRNA Production

Companies embarking on mRNA production will need to procure custom raw materials, which pose new challenges, such as long lead times, limited suppliers, small batch quantities, and ever-changing and developing expiration periods. Here are approaches to alleviate some of the challenges associated with using custom raw materials. While there is no silver bullet, implementing one or all of these strategies discussed here can help companies better plan and fulfill their manufacturing demands.

  1. Multi-sourcing: more than one vendor for procuring custom raw materials
  2. S&OP process: visibility into the forecast and strong communication between all parties
  3. Packaging size: optimizing material usage by linking packaging size to batch size
  4. Material expiry: determine your risk tolerance for expiring materials

Read the Full Article Here