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Go CMO: guidelines for choosing a stem cell therapy manufacturing partner
As the stem cell therapy industry continues to grow, so does the need for trusted contract manufacturing organization (CMO) partners that can provide a safe, reliable source of cells for therapeutic development. A CMO is a company that provides manufacturing services to other companies on a contract basis. In cell therapy manufacturing, such partners are important because they have crucial technical, regulatory, and manufacturing expertise.
Choose a CMO based on these key selection criteria:
- Expert sourcing of starting material. Your CMO should work with you to define the exact specifications of your cells and retrieve them from FDA-compliant sources according to FDA guidelines.
- Established protocols. To ensure product safety in downstream clinical cell therapy applications, your CMO should have a feeder-free and animal/human-component-free method for generating robust cell lines.
- GMP compliance. Make sure you pick a CMO that operates according to guidelines for Good Manufacturing Practices, so you can be confident that the products are high quality and meet regulatory standards.
- Extensive experience and strong reputation for partnerships. You'll want to make sure that your CMO has a history of successful partnerships, so you know you can depend on them.
- Customized solutions. The best CMOs will have experience providing custom solutions to their partners and will be able to support them with innovative solutions across all stages of the development process.
Takara Bio was recently recognized by the stem cell industry blog BioInformant as the first company in the world to offer CMO services for the derivation and banking of human embryonic stem cells (hESCs) under GMP conditions. Read the full article to learn more about what makes Takara Bio the ideal partner for generating hESCs as starting material for downstream clinical cell therapy applications.
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