Start with the End in Mind: Materials Control in Early CMC Strategy

From supplier risks and regulatory inconsistencies to challenges with variability and quality attributes, the article in Manufacturing Chemist outlines why material sourcing decisions made at the earliest stages can make or break a therapy’s progress to market. Rob also shares five key questions developers should ask before finalising their CMC plans, covering safety, security of supply, quality-critical materials and regional compliance.

Whether you’re scaling an autologous product or working with novel platforms, this article highlights why a strong materials strategy is not just operational; it is strategic.

“Having control of the materials used to manufacture a drug product from the point at which discovery is made ensures that it receives the best opportunity for success.”

Rob Scott

Head of Translation Consultancy

Key takeaways from the article include:

• Materials control is central to a successful CMC strategy, particularly in cell and gene therapy where many components are complex, variable or sourced from human donors.
• Early-stage sourcing decisions can have long-term impact on product quality, regulatory acceptability and commercial scalability.
• Using research-grade materials may be expedient, but it risks rework or regulatory issues later in development if those materials cannot be used in GMP manufacture.
• Developers must assess supply chain resilience early, especially for short shelf-life or import-restricted materials.
• Not all raw materials carry equal risk, so a structured risk assessment and mapping process is essential.
• Regulatory definitions and expectations vary by region, so understanding what each agency requires for materials control is critical.

Read the full article in Manufacturing Chemist: Start with the end in mind: the role of materials control in early CMC strategy for cell therapies