QMS for Cell and Gene Therapies (C&GT): Why Data Visibility and Integrated Risk Management will Drive Product Quality and Patient Safety

While CGT holds a lot of promise, it is not without its challenges, over and above those faced in the regular drug discovery and development process. Ensuring cell viability across the lifecycle of the process is critical, right from the collection stage to the development of an effective therapeutic product. Any compromise will affect treatment efficacy, which may put the patient’s health and even life at risk. Therefore, the process will have to begin afresh with the acquisition of a new sample, which can be difficult to procure and delay the development process.

Broadly, the risks can be categorized into the following aspects:

Mix-up in Patient/Product: Setting up the right Chain of Identity (CoI) and Chain of Custody (CoC) processes is critical to avoiding mix-ups.

Importance of Timing: By the time the product is released, it may be too late for the patient to benefit from the therapy. Therefore, speed and agility are extremely important for CGT development.

Collection Quality: The FDA has stressed the risks involved in the collection stage and recommends the implementation of well-designed process controls and Standard Operating Procedures (SOPs) to lower the variability of starting and in-process materials.

Maintaining Quality: To improve the quality of CGTs being developed, few approaches will certainly help, such as, integration of a next-generation EQMS into your development lifecycle, aligning product quality goals, regulatory goals, all clinical and non-clinical goals, engaging with the regulators as partners, keeping compliance at the front and center of the CGT process, etc.

In this whitepaper we talk about:

• Some common challenges faced by CGT companies
• Taking a risk-based, quality-first approach to CGT development
• Why CGT manufacturers need a data-driven next-generation EQMS
• And more