Microbiology Quality Control Helps the Cell and Gene Therapy Segment Cure the Incurable

In the pharmaceutical industry, the quality control process is crucial to ensuring both public safety and success rates for treatments. The last line of defense between the drug and the patient, this area of production can be viewed as a foundational necessity rather than an area of continued innovation with opportunities for revenue generation.

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Quality control is a purpose-driven profession, which I often refer to as the last noble one. At the onset of my career, I was fortunate enough to have a job in quality control, in which I could begin to understand what it meant to be a microbiologist in the pharmaceutical industry on a daily basis.

This role was grounded against the impact that our medicines and innovations had on human life and over time, I developed a passion for quality control, as our team worked to ensure our environment was clean and safe for production of medicines that further public health.

Fast forward 2 decades—with the continued advancement and approval of cell and gene therapies, the need for trustworthy, microbiology quality control solutions is at an all-time high. Professionals across this highly innovative segment are working together to transition the academia-based inception of these novel therapies to moving them into clinical, and eventually, industrial environments. Traditional pharma quality control processes can lack the agility and speed needed to meet critical patient needs.

Cell and gene therapies are most often administered as a last effort to save a patient’s life against terminal illness. Time is the most precious commodity for these patients as they await release approval of therapies, or even as they await their own treatment. This heightens the stakes for everyone involved in the quality control process for these therapies, as contamination could result in loss of life.

I’ve had a front row seat to see the magnitude of the developments in the cell and gene therapy segment over recent years, and one of the most rewarding parts of my role now is to collaborate with companies of all sizes to help them navigate the constantly changing landscape of individualized medicine.

Although no 2 collaborations are exactly the same, patterns do begin to emerge on the areas in which drug companies are leaning on the support of knowledgeable pharma quality control partners to help develop tailored solutions that adhere to the following criteria:

Rooted in Industry Segment Best Practices. No 2 drug companies, therapies, or solutions are alike. The rapid innovation in the cell and gene therapy segment requires a quality control partner that can distill the latest research and findings, which publish daily, and apply the larger industry learnings to a customized solution that works for their customer.

Streamline Resources. Similar to myself, many people begin their career in quality control and subsequently move to a different area of pharma. As a result, any sized organization within the industry can have a gap of skilled human resources to carry out the quality control responsibilities across the manufacturing process. Quality control partners must understand these gaps and design testing solutions with optimized, rapid, and simple workflows that consider a company’s existing resources to ensure success. And higher rates of success are crucial when funding is such a barrier to entry right now for manufacturers of cell and gene therapies.

Fit For Purpose. The FDA is poised to approve a significant amount of new therapy offerings in the next few years, doubling the number of available therapies that are currently on the market. As these offerings are considered alternative methods, governing bodies understand that diagnostic testing solutions must evolve to keep pace with the industry. We expect that regulators will be applying higher levels of scrutiny as their own knowledge continues to grow.

Because each therapy is different, naturally there are multiple ways to validate an assay—and one way is not necessarily more correct than another. Testing partners must be able to advise on the best path forward for each circumstance (suitability vs. validation), as well as have in-depth knowledge of a lab’s specifications to ensure the offering is designed to provide a pathway for regulatory acceptance.

With rapid advancement in bringing approved individualized medicines to the market through the cell and gene therapy segment, the need for trustworthy, microbiology solutions is at an all-time high. Quality control partners with extensive in-field experience are best positioned to equip both in-house and external labs with the tools they need to successfully bring innovative, life-saving therapies to the market at a rapid pace without cutting any corners.

About the Author

For more than two decades, Nadia Ward has built a noteworthy reputation as a dynamic leader in the Life Sciences industry. Prior to her current role as Business Development Manager, Cell and Gene Therapy, at global in vitro diagnostic company bioMérieux, Ward worked for high-profile biopharmaceutical companies, including Pfizer and Diosynth. Ward has deep knowledge of quality control considerations across the industry, with expertise in USP and FDA Drug Regulations, Corrective and Preventive Action (CAPA), current Good Manufacturing and Laboratory Practice (cGMP & GLP) and Medical Devices. Based in the Raleigh-area, Ward holds a Bachelor of Science in Chemistry from Florida Atlantic University.