Cell therapy weekly: commercial agreement to manufacture CASGEVY
This week: SK pharmteco (CA, USA) and Cryoport Inc. (TN, USA) have entered into an agreement to offer fully integrated logistics and manufacturing services to further support biopharmaceutical companies and the CRISPR/Cas9 gene-edited therapy, CASGEVY®, will be manufactured at Lonza‘s (Basel, Switzerland) current Good Manufacturing Practice (cGMP) state-of-the-art facilities. Plus, Terumo Blood and Cell Technologies (Terumo BCT; CO, USA) and Nova Biomedical (MA, USA) have partnered to automate cell culture analyses.
The news highlights:
- A partnership to fully integrate services to further support life science companies
- Commercial agreement to manufacture CASGEVY®
- A partnership to automate cell culture analyses
A partnership to fully integrate services to further support life science companies
SK pharmteco and Cryoport have announced a partnership to provide combined logistics and manufacturing solutions to biopharmaceutical companies. The companies aim to strengthen SK pharmteco’s manufacturing capabilities, which include small molecules and cell and gene therapy products, by leveraging Cryoport’s supply chain services and equipment.
Dana Cipriano, Vice President of Analytical Services for SK pharmteco stated: “The cell and gene therapy industry continues to see substantial growth, and ensuring the safety and integrity of the supply chain is essential for these products. We are dedicated to our clients, and partnering with Cryoport reflects our commitment to providing the highest-quality services that are specifically tailored to meet the needs of our customers and the patients they serve.”
Commercial agreement to manufacture CASGEVY®
Lonza has entered into an agreement with Vertex Pharmaceuticals (MA, USA) to manufacture CASGEVY®, the first CRISPR/Cas9 gene-edited therapy for sickle cell disease and beta thalassemia. The long-term commercial agreement will allow Vertex access to Lonza’s expertise and commercial manufacturing capabilities.
CASGEVY® will be manufactured at Lonza’s state-of-the-art cGMP cell therapy manufacturing facilities in Geleen, Netherlands, which recently received a GMP license from the US Food and Drug Administration (FDA; MD, USA), the European Medicines Agency (Amsterdam, Netherlands) and the Medicine and Healthcare Products Regulatory Authority (UK).
“It is a privilege to work with Vertex on bringing its innovative and cutting-edge medicines to patients suffering from life-threatening diseases,” said Daniel Palmacci, President of Cell and Gene at Lonza. “We are also pleased to reach a significant milestone towards supporting the commercial manufacture of CASGEVY® by receiving the regulatory approval at our state-of-the-art cell therapy manufacturing site in Geleen.”
The companies plan to expand the manufacturing of the therapy to Portsmouth (NH, USA) under GMP conditions in 2025.
Partnership to automate cell culture analyses
Terumo BCT and Nova Biomedical have partnered to automate cell culture sensing by integrating Nova’s BioProfile FLEX2 Automated Cell Culture Analyzer into Terumo BCT’s Quantum Flex™ Cell Expansion System. The FLEX2 encompasses a range of analytical capabilities that will enhance process development through the Quantum Flex™ platform, providing near-real-time data for sampling and analyzing a comprehensive range of therapeutics, including cell-based therapies.
“Our cell therapy customers have stressed the importance of adding automated cell culture monitoring features to Quantum Flex™,” commented Veerle d’Haenens, General Manager of Global Therapy Innovations at Terumo BCT. “Nova Biomedical is a strong partner to help us integrate these features for better process development and characterization. It will also improve monitoring and control during production, given the FLEX2’s comprehensive analyte set and demonstrated performance in the cell therapy space.”
