We are pleased to bring you a new series on “Best Practices in the CDMO Selection Process”
Pharmaceutical development companies of all sizes frequently outsource their Active Pharmaceutical Ingredient (API) manufacturing to CDMOs for various reasons, including: a) limited internal know-how and capacity to manufacture API according to Good Manufacturing Practice (GMP) or b) to reduce costs and timelines.
The CDMO series provides sound advice to agile biotech companies in identifying and selecting the right Contract Development and Manufacturing Organization (CDMO) for advancing the development of their product(s), in conjunction with successfully managing a chosen CDMO to meet the company’s expectations.
In these articles, we will explore the common reasons why a company might consider engaging a CDMO. We will focus on how to the evaluate CDMOs, detail the best practices for working with a CDMO to ensure the success of your product development, and more.
Why—and When—to Use a CDMO
In this 1st article of the series, we explore three common reasons why a company might consider engaging a CDMO.
Determine Your Priorities to Finding the Right CDMO
In this 2nd article of the series, we detail the best practices for working with a CDMO to ensure the success of your product development.
What to Look for in a CDMO
In this 3rd article of the series, we focus on the evaluation of a few identified CDMOs. There are several factors to consider and while some may be subjective to your company’s needs and culture, most should be quantifiable and tracked in a spreadsheet that lets you compare potential CDMOs in a like-for-like way.
Critical Quality Attributes for Drug Products
In this 4th article in the series, we explore the importance of Critical Quality Attributes (CQAs) in the drug development lifecycle and why it is vital that your selected CDMO is capable of addressing them.
How To Choose the Right Analytical Methods
In this 5th article of the series, we focus on the analytical method development around your biologics. Analytical method development is an important component of biologics development and the control of quality attributes that affect product performance and stability is critical to success.