Chamow & Associates is pleased to present a blog series detailing best practices for working with a contract development and manufacturing organization (CDMO). This series is intended to provide a potential sponsor company with sound advice in finding and choosing the right CDMO for its product development and managing that CDMO to perform to the company’s expectations. We begin our series at the start of this process – “Reasons to Use a CDMO”.
Working with Contract Development and Manufacturing Organizations
Today, it is common for pharmaceutical development companies to outsource manufacturing support for their Active Pharmaceutical Ingredient (API). For smaller organizations, the case can simply be that they do not have the capability internally to manufacture GMP API. For larger companies, reasons to outsource manufacturing are varied. It is helpful to understand the catalyst for this decision as it affects priorities to be later discussed when choosing a CDMO. There are three common reasons why a company will use a CDMO.
Early clinical development naturally leads to a fast cycling of projects as candidate molecules are nominated and prioritized. A company can try to provide staff and capital to allow for this fluctuation in demand, but it is at its discretion whether or not to overcompensate for this variability. If a company invests capital and internal resources in manufacturing, it is in its best interest to choose not to let these assets sit idle because of the associated high cost.
Greater external technical expertise
The technical expertise needed to manufacture an API often cannot be supported internally. Finding a CDMO with people who have greater knowledge not only can benefit a company financially, but can greatly improve quality and timeline as well.
While it may seem like cost reduction is a guarantee when choosing to use a CDMO, the true savings comes from the CDMO selection strategy. A company needs to make sure it is utilizing its current internal resources and contracting out only what can be better performed out of house. If this strategy is carried out well, the savings can be substantial.
Knowing your foremost reasons for using a CDMO can affect your priorities when choosing a CDMO, which we will discuss in our next post for this series.
Chamow & Associates assists companies to develop biologics for clinical testing and welcomes your inquiry.