Explore our newly expanded portfolio of GMP-grade Small Molecules for a variety of research and cell therapy applications. All our GMP Small Molecules are produced in strict accordance under controlled cGMP guidelines, assuring safe, reliable, and consistent ancillary reagents.
Small molecules are increasingly being used as tools to modulate signaling pathways and understand stem cell biology. As your research program advances into therapeutic applications, making the transition from research-grade to GMP-grade reagents is critical to the success of your project. Captivate Bio can facilitate this transition easier with the availability of RUO-grade and GMP-grade small molecules that are designed with enhanced quality testing and documentation and are suitable for use as ancillary reagents.
GMP Small Molecules are synthesized following ICH Q7 guidelines in ISO 9001 and cGMP certified facilities. Each batch undergoes strict QC tests including purity, water content, residual solvents, bioburden, endotoxin, elemental impurities, and solubility.
The following quality assurance documentation is available for all GMP small molecules: Certificate of Analysis (CoA), Safety Data Sheet (SDS), Certificate of Origin (CoO), TSE/BSE Statement, Product Specifications, and Declaration of GMP Compliance.
For those requiring GMP-grade material, supplier NDAs, quality audit questionnaires, and in person audits are available. Contact us today to get started.
An important consideration when developing a cell therapy is deciding to change from RUO-grade to GMP-grade reagents. Although the quality of the reagent should be similar, GMP-grade reagents provide enhanced quality testing and tighter manufacturing specifications. We recommend identifying primary and secondary suppliers early on in your research, who can support your preclinical development as you look to move from RUO to GMP. This will help you avoid delays or time-consuming and expensive comparative studies during the later stages of your research program.
Don’t see what you are looking for? Captivate Bio can will work with you in moving from RUO to custom GMP-grade small molecules for manufacturing use. Contact our team today to inquire about custom small molecules.
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