Ensuring Quality in Contracted Support

Posted: 15 February 2024

Our Vice President of Quality, Iain McGhee, worked with the team at Pharmaceutical Technology to provide a quick overview of how to ensure quality when looking for a contract development and manufacturing organization (CDMO) partner for their Q1 2024 Outsourcing Innovation e-Book.

Outsourcing process development and manufacturing of advanced modalities to CDMOs can reduce upfront costs, speed development timelines, and allow therapy developers to focus on innovation. Quality and efficacy must also be assured, and therefore selecting the right outsourcing partner is essential. It is important to choose a CDMO with a wide platform of tools that can be tailored to meet regulatory compliance as well as customer pharmaceutical quality system (PQS) requirements.

A CDMO should take a consultative approach and develop Quality Agreements with a greater focus on client needs, including early engagement and discussion of complex issues, open and honest dialogue about every detail, and clear documentation of agreed upon expectations. The CDMO’s company culture and service approach should also be compatible. Preference for a small, agile CDMO that can move quickly or a large, formal more slowly moving CDMO with well-established quality systems must be determined as well.

Assays are such a critical component of quality because they are used to guide process development, release the product, inform stability, and to demonstrate process robustness. Too much variability in the assay will result in sub-optimal decisions and may result in a lower yielding process and longer-term operational costs. If outsourcing process development, it is essential to find a CDMO that understands the need for accurate assays as early as possible in a project and can quickly generate material for analytical development using small-scale models.

An outsourcing partner can impact all aspects of a development project, including time, cost, and quality. Choosing the right CDMO with appropriate experience, staffing, technical capabilities, approach to quality and compliance, and capacity to support your project is critical. Open dialogue with a like-minded CDMO is the best way keep processes running smoothly and get advanced therapies to where they are needed so people can live better and longer lives.