The Criticality Of CMO Selection For Small Biopharma Companies

By Steve Kornher, Ph.D.

For pre-clinical or early-stage biopharma companies, the choice of a Contract Manufacturing Organization (CMO) is a pivotal decision that can significantly impact their future success. Opting for the right partner hinges on the ability to carefully assess and weigh the trade-offs presented by each potential manufacturer.

Established and larger CMOs typically possess infrastructure designed to adhere to Good Manufacturing Practices (GMP) for phase 3 or licensed products. This entails a higher level of Quality Assurance (QA) oversight and regulatory requirements for all aspects of manufacturing and Quality Control (QC) testing, which surpass the demands of pre-clinical or phase 1 drug candidates. When the development phase of the sponsor's project and the CMO's quality processes are not in alignment, it can lead to substantial cost increases and timeline delays in a clinical program. The outcome of this program may well determine the success or failure of the sponsoring organization.

On the other hand, smaller CMOs might lack a mature infrastructure with specific QA procedures, materials management, supply chain capabilities, metrology, and may also be deficient in experienced personnel in the manufacturing domain.

Selecting the right CMO is, in fact, a long-term commitment, necessitating a substantial investment of a small biopharma's time, resources, and financial capital. Making the correct CMO selection from the outset is paramount to securing a promising future for the sponsoring organization. Access the article below where this author delves into the criteria that small or early-stage biopharma companies should consider during their CMO selection process, along with key considerations to keep in mind.