Selkirk Pharma is a U.S. based contract manufacturing organization specializing in the sterile fill and finish of injectable drugs, including vaccines and biological therapies. Their state-of-the-art facility in Spokane, Washington boasts cutting-edge technology and recently completed the implementation of 3P^® ENTERPRISE.

Lauren Coyle, Commissioning Editor, Cell & Gene Therapy Insights, speaks with Dhruv Sareen, Executive Director at Cedars-Sinai Biomanufacturing Center, and Jonathan Rodriguez, Quality Control Manager at Cedars-Sinai Biomanufacturing Center, about the roles of in-process controls, method validation, risk management, and automation in biomanufacturing.

bioMérieux sat down with experts from NecstGen to discuss the value of this partnership, the impact of rapid quality control, and the future of CGT.

“We show our partners that they can trust us to use all our means possible to achieve the goals that we have agreed on.” - Catherine Bach, Pharma QC Strategic Accounts Director

With a complete portfolio of Quality Control solutions, bioMérieux ensures the safety of patients undergoing cell and gene therapies. - Felix A. Montero Julian, PhD Scientific Director Pharma Quality Control 

Our 3P® ENTERPRISE solution can really make a difference by helping a faster drug release to address the patients’ needs.” - Laurent Leblanc, R&D Manager

bioMérieux had the opportunity to sit down with Ashley Trueheart, former Director of Product Design and Development at Eagle Analytical (Eagle) to discuss how they provide customers the fastest time-to-results using SCANRDI®, a safe and proven method for sterile product release.

We anticipate reaching our breakeven point after approximately 11 months of final product testing — representing approximately $200,000 in savings over the next 5 years 

What’s new in the cell and gene therapy landscape? What is the role of quality control in efforts to scale up manufacturing of CGT products and alleviate talent constraints?

Is the future of cell and gene therapy autologous or allogeneic? Which solid tumour may receive the first cell therapy treatment? How will the use of ATMPs in cancer care change our healthcare structures in years to come? Discover all this and more in this podcast with bioMérieux.

In this ‘Experts Interview’ feature published on CELL & GENE THERAPY INSIGHTS, Felix Montero Julian (Healthcare Scientific Director, bioMérieux) and Rey Mali (Vice President Sales and Marketing, Accellix) share their perspectives on current Quality Control challenges and special needs in cell and gene therapy production.