Clinical Grade vs Reagent Grade

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The stem cell therapy field is still nascent but the potential to revolutionize the future of healthcare if stem cell research lives up to its promises is enormous.However, there are steep challenges faced by the field to unlock the full capabilities of regenerative medicine and stem cell therapies.Stem cell based therapeutics demand the highest quality reagents in concert with judicious processing, storage conditions, formulation, expertise and facilities to be able to generate cells that are safe and effective for clinical administration.Ultimately, Current Good Manufacturing Practice (cGMP) must be utilized and strictly adhered to safeguard and maintain the quality of cellular based products.Akron is dedicated to closing the gap between concept and commercialization to enable researchers and the industry alike overcome these complex barriers and exploit this exciting opportunity.  Successful delivery of these objectives demands an innovative and integrated business model that offers both the most advanced and highest quality tools and technologies together with bespoke services to support the stem cell community. As a cGMP manufacturer of reagents, Akron offers the industry’s widest array of stem cell specific reagents and unlike other suppliers is able to deliver custom products to meet your every need. It is important to understand the GMP-quality affairs and regulatory requirements for reagents used in the processing and manufacture of stem cell therapies and that reagents are just one aspect of delivering a therapeutic product to market.   Akron’s experienced staff will provide comprehensive guidance and regulatory support throughout your pre-clinical and clinical development program.   In addition, Akron’s facilities and know-how offers unparalleled services in nonclinical development aspects.  Our services support clients in the custom design, setup and validation of GLP-compliant bioassays, such as potency assays which are fundamental to ensuring quality of the cellular product in Phase II clinical trials and beyond.

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