What to Look for in a CDMO

This article is the third part of our “Best Practices in the CDMO Selection Process” series, through which we intend to provide 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.

Publications
Published on:
September 8, 2022

In this article we will 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. Let’s review the most important factors in creating a successful sponsor-CDMO relationship.

Overall, these attributes should illustrate whether a CDMO can deliver the quality and amount of product at the right cost."
Technology fit

The most important question to ask is whether a CDMO has the right technology for your product needs. The CDMO must be able to produce your product. If not, nothing else matters. To assess the CDMO’s technology capability, ask if they have the:

  • Required microbial and/or mammalian expression technology
  • Development expertise and resources to support production. This includes cell line, process, formulation, and/or analytical method development—tasks that are separate to the GMP tasks of master cell banking, drug substance, drug product, clinical labeling, and clinical packaging.
  • Available stainless steel and/or single use production systems required for products that include drug substance (DS). Other related questions to ask here are: Are you transferring an existing process from another facility? If so, does the production equipment match?
  • Production scale capabilities to match your product needs.
Project Management

Project management is a crucial service provided by a CDMO. Note whether their delivery dates are realistic and if the timeline fits your schedule. Also, during your CDMO visit, observe their communication style and staff culture. Make sure this complements your own company culture and style.

Location

Location is another important consideration. For non-clinical and early-stage clinical programs—where the CDMO has no experience with the product molecule—close communication between sponsor and CDMO is essential. Generally, a CDMO encounters fewer program issues when the sponsor is and remains engaged. Eventually, every project will require technical transfer. If a CDMO is technically competent with a strong track record of tested systems, they encounter fewer issues and often solve issues they do encounter on their own. This can make location less of a factor; however, you must assess your communication and collaboration needs as well as the impact distance may have.

Overall, these attributes should illustrate whether a CDMO can deliver the quality and amount of product at the right cost. A good CDMO will know its strengths and be willing to seek outside assistance for any present gaps. Ultimately, it is about managing risk, so weigh that against all other factors.

If you have decided to outsource your manufacturing and would like to identify the right CDMO for your project, we are here to assist. Our expert team has been helping companies choose the right CDMO for more than a decade – reach out to us to learn how we can support.

Related news

News September 27, 2022
AseBio and Alira Health Partner to Foster Market Access for Biotech Startups
Alira Health and AseBio, the Spanish Bioindustry Association, are joining forces to support Spanish biotech companies looking to enter new markets.
Biotech Market Access Startups
Publications September 14, 2022
Critical Quality Attributes for Drug Products
In this article, we will 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.
Biotech CDMO Drug Development
Publications September 8, 2022
Best Practices in the CDMO Selection Process
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(...)
CDMO
Publications September 8, 2022
What to Look for in a CDMO
In this article we will 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,(...)
Biotech CDMO Contract Development and Manufacturing
News September 6, 2022
Alira Health Expands North American Capabilities with the Acquisition of Artisan Healthcare Consulting
The acquisition of Artisan strengthens and extends Alira Health’s Market Access and Management Consulting advisory practices in North America and globally.
Biotech Market Access Pharma Therapeutics
Publications September 1, 2022
Determine Your Priorities to Finding the Right CDMO
In this article, we will detail the best practices for working with a CDMO to ensure the success of your product development. After having identified the need for engaging a CDMO, the(...)
Biotech CDMO Contract Development and Manufacturing
Publications August 25, 2022
Why—and When—to Use a CDMO
Pharmaceutical development companies of all sizes frequently outsource their Active Pharmaceutical Ingredient (API) manufacturing to CDMOs for various reasons. In this article, we explore(...)
CDMO Pharma Research and Development
Welcome to Alira Health. This site is best viewed in Chrome, Microsoft Edge, or Firefox.