Ensuring Quality in Contracted Support

Working with a contract development and manufacturing organization (CDMO) is a great way for smaller or diversified biotech companies, and even Big Pharma, to expand operations or modalities to reach the patients more efficiently. Outsourcing process development and manufacturing requires a lesser upfront investment with faster timelines while allowing teams at advanced therapy developers to focus on innovation. However, this relationship can deeply impact the quality and efficacy of a product. This article explores the balancing act of ensuring regulatory compliance via internal procedures at a CDMO and what to consider when starting
this relationship.

Quality in the contract

CDMOs will always have multiple customers, as this is how their business model is built. It can be an uncomfortable position to seek a CDMO, particularly for those coming from Big Pharma, where there is direct quality oversight over processes. Looking for a CDMO with a wide platform of tools that can be tailored to meet regulatory compliance and both provider and customer pharmaceutical quality system (PQS) requirements is important.

Unfortunately, many CDMOs offer quality processes with minimal flexibility for customers because this is the easiest for the CDMO to control. Doing this minimizes the risks associated with customer specific variations to processes, reduces costs for the CDMO, and is easier to defend during inspections. However, this can lead to a disconnect between the customer and the supplier.

When CDMOs develop quality agreements with a greater focus on client needs, it can increase trust, compliance, and even make audits easier to manage. Complex procedures can be simplified by engaging all parties and clearly documenting in the quality agreement from the start. While this may add initial time and cost, over the long run this will pay out with less process issues, including errors or oversights.

Defining a relationship

A CDMO should ask a lot of questions and take a consultative approach to building the quality agreement. Take a close look at their platform and internal quality standards and how this aligns with the needs of a product. Set the expectations out clearly, including defining the roles and responsibilities for the CDMO and customer. The agreement will clarify when and how to incorporate customer specific requirements and identify any areas for risk to address from the start.

Ensure that during this stage, and throughout the relationship, there is always open and honest dialogue about every detail. For instance, what is considered a repetitive deviation and when does a customer feel the need to sign off on it. The customer may define the second occurrence of an event as repetitive, while the CDMO might define it as the third occurrence.

Read the article in the Partnerships for Outsourcing eBook.

Article details

BioPharm International®
Partnerships for Outsourcing eBook
May 2024
Pages: 18-21

Citation

When referring to this article, please cite it as McHee, I. Ensuring Quality in Contracted Support. BioPharm International Partnerships for Outsourcing eBook, May 2024.