NeoStem, Inc. (Nasdaq:NBS), a leader in the development and manufacturing of cell therapy products and regenerative medicine, and Invetech Pty Ltd, a global leader in instrument development, custom automation and contract manufacturing, today announced an agreement for the development of a new closed processing system for cell therapy manufacturing. Under the agreement, Invetech will provide system design and engineering development and NeoStem will develop applications for performing closed cell processing manipulations such as separation. The agreement envisions NeoStem as the commercial supplier of the system which would constitute its first branded entry into the cell therapy tools market.
The system will be applicable to a range of cell therapy processes in development and commercialization stages, and will consist of an instrumentation platform, disposable flow path, and operating and application software for automated execution of user-selected protocols. The system will provide a flexible small-scale process suitable for GMP manufacturing of autologous and other patient-specific products where small scale is full scale, while also supporting efficient development of processes at lower cost prior to transitioning to scaled volumes.
“We are pleased to be partnering with Invetech on the development of a new technology specifically designed to meet the needs of our clients as their cell therapy products progress through clinical trials on a path towards commercialization,” said Robert A. Preti, Ph.D., President of PCT and Chief Scientific Officer of NeoStem. PCT will carry out the work and is a wholly-owned subsidiary of NeoStem. “By combining PCT’s more than 15 years of process development and manufacturing experience with Invetech’s industry leading automated processing device expertise, we hope to produce and potentially market a system that would deliver significant cost of goods, quality, and scaling benefits over existing manual, cleanroom-based processing strategies.”
“Working with NeoStem to create equipment that will deliver services to companies in the emerging cell therapy industry is exciting and satisfying,” said Richard Grant, Global Vice President, Cell Therapy Division of Invetech. “Our team shares a common passion with NeoStem to grow the cell therapy industry by developing new technology to support successful product development and commercialization.”
“NeoStem’s Engineering and Innovation Center (EIC) is one of the first dedicated centers responding directly to the major challenges that are facing the manufacturers of cell based therapeutics,” said Brian Hampson, vice president, manufacturing development and engineering. “If ultimately commercialized, the sale of disposables associated with the System, especially for patient-specific therapies where one disposable set is used per patient, could potentially become a meaningful revenue area for NeoStem.”