One aspect of the CMO biological services process is preparing applications to the Food and Drug Administration (FDA). FDA prior approval is required that a drug is both safe for humans and effective for its intended purpose.
Through an Investigational New Drug (IND) application, a maker obtains an exemption from the legal requirement that a drug have an approved marketing application before it is transported or distributed across state lines. (Necessary because many drugs cannot be tested without shipping to multiple investigators in many states.)
Through a New Drug (ND) application, a sponsor demonstrates to the FDA that it has collected sufficient evidence of the drug’s safety and effectiveness to justify bringing it to market.
Both applications are rigorous and time-consuming. Many drug initiators (pharmaceutical and biotechnology companies and academic non-profits) contract with a third-party company only for these submissions (some drug initiators want a soup-to-nuts contractor with expertise in all aspects of CMO biologics services).
Further information on the application process is available from the FDA’s website.
KBI Biopharma, Inc. is a development and contract manufacturing organization serving the biopharmaceutical industry. Its process development and manufacturing programs apply insights from its protein characterization methodologies towards the development of robust and scalable processes. The company’s scientific, quality and regulatory staff offers extensive experience – proven through numerous IND and NDA submissions – to meet the challenges that arise at all stages of drug development.