The Pharmaceutical Contract Manufacturing Organization (CMO) industry is a $10 Billion dollar a year industry in the U.S. alone and growing. As more companies enter this expanding market space, it is imperative to look at certain factors when partnering with a CMO. These 3 factors are Expertise, Efficiency and Innovation.
Expertise – Expertise encompasses knowledge of the whole development cycle, regulatory compliance and manufacturing process from start to finish for OTC’s, ANDA’s or NDA’s. It means quality compliance and quality assurance is their top priority. Additionally, cost targets will be accurate and comprehensive and product performance will be consistent throughout production. To achieve uniformity in product performance, stringent controls with a strict focus on standard operating procedures (SOP’s) will be in place and should be evaluated.
Efficiency – An efficient CMO is always reviewing their processes and looking for ways to improve their efficiency and cost-effectiveness. It is through experience and process management that a CMO can offer great value. Another characteristic to look for are what operational excellence practices have been institutionalized. This is a strong indicator to a manufacturer’s commitment to principles.
Innovation – In order to become a market leader, partnering with an innovative CMO is obvious. Innovative CMO’s are constantly looking to improve a product’s quality while still ensuring regulatory compliance. Innovation can be in the form of an ongoing push to develop patient-friendly products or an offer of innovative formulations to set your product apart from the competition.
These 3 important factors when deciding on which CMO to partner with could be the determining factor between success and failure.