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Raw or ancillary materials are materials that are used in ex vivo cell manufacturing but are not intended to be a part of the final product formulations. This includes materials such as growth factors, activation antibodies, nucleases, and more. We have crafted a comprehensive array of GMP-grade materials to support your cell manufacturing for clinical studies. Here’s why ACROBiosystems is your partner of choice:
1. Qualified raw materials in cell therapy manufacturing
Cell therapy manufacturers are required to ensure that raw materials used during manufacturing are of low risk and safe for use. Our stringent quality standards and adherence to regulations ensure that our GMP ancillary materials meet the highest benchmarks for batch-to-batch consistency, stability, safety, and efficacy, mitigating risks and safeguarding patient safety.
2. Aseptic production: Vital for success in cell therapy manufacturing
Sterility is crucial in cell therapy manufacturing to prevent contamination and ensure patient safety. Suppliers should adopt integrated approaches to aseptic control, encompassing facility design, equipment maintenance, process optimization, and personnel training. Compliance with regulatory standards such as EU GMP Annex 1: Manufacture of Sterile Medicinal Products and FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing is essential to uphold product integrity.
3. Ensuring cell therapy product quality through consistent raw material bioactivity
The consistency of raw material bioactivity is a key indicator to guarantee the efficacy and reliability of cell therapy products. Our GMP growth factors and cytokines are engineered to deliver exceptional consistency in bioactivity and tailored performance for your specific cell culture applications with thorough and transparent evaluations. The promise of ensuring raw material consistency not only streamlines the transition from preclinical research to clinical manufacturing but also instills confidence in the quality and potency of the final cell therapy products.
4. Trustworthy raw material suppliers for navigating regulatory complexity
The relationship between raw material supplier and manufacturer is not purely transactional but rather a partnership. With our in-depth understanding of guidance across the globe, our experienced quality team is prepared to support IND or BLA applications with our comprehensive material regulatory documentation and expertise. Compliance with pharmacopeia documents underscores our commitment to quality, enhancing the safety and efficacy of CGT products.
For additional information: www.acrobiosystems.com
