The cell and gene therapy market is expanding at a rapid pace.
The market holds immense promise not just for treating diseases, but also for curing them. However, as this field continues to flourish, the growing skills gap is evident, particularly in the realm of quality and manufacturing within cell and gene therapy (CGT).
To gain insights into these challenges, I’ve been speaking with several quality leaders in the CGT sector. In this article, we will explore the nature of this skills gap and discuss potential strategies to overcome it.
One of the primary challenges lies in the fundamental lack of understanding about the appropriate level of Good Manufacturing Practices (GMP) in CGT, especially as companies progress through clinical development. It becomes difficult for cell and gene therapy companies to determine the extent to which GMP requirements should be implemented. Professionals transitioning from the pharmaceutical industry to CGT often assume that full-scale GMP is necessary, even in the preclinical stages. This misconception persists as companies navigate the clinical development process, leading to confusion regarding where GMP is required and what type of GMP should be followed.
Smaller firms face specific hurdles due to their reliance on homegrown quality and regulatory expertise, often lacking a dedicated Quality Assurance (QA) function. This inadequacy hampers the progress of therapies, resulting in delays in bringing products to market. It is crucial for preclinical companies to avoid overloading their infrastructure with overarching GMP requirements. By doing so, they risk impeding their own progress and missing out on the opportunity to swiftly deliver their products to market.
To tackle this challenge, we must approach talent acquisition and training with a spirit of compromise. While it may be tempting to recruit individuals with extensive experience in traditional pharmaceutical or biologics manufacturing, it is important to recognize that cell and gene therapies require a unique skill set. Professionals with a background in solid dose or capsule manufacturing possess an understanding of GMP principles, but applying them to CGT can be intricate. These individuals may lack the necessary comprehension of the infrastructure and processes specific to CGT. Consequently, the key lies in training and developing the right talent—individuals who possess the right attitude and can be taught the nuances of CGT and how to lead it to the finish line.
One potential solution lies in fostering a quality culture and emphasizing its significance in the CGT field. When identifying talent, it is essential to understand why quality matters to them personally. Building a quality culture must begin from within the team, rather than solely relying on senior leadership. While leadership plays a crucial role in driving the culture, it is equally important to find individuals who genuinely comprehend the impact their work can have on patients’ lives. Patient safety should be at the core of their motivation, driving their commitment to maintaining the highest quality standards throughout the CGT process.
In conclusion, the growing skills gap in the quality and manufacturing space within cell and gene therapy poses significant challenges for companies striving to bring life-changing therapies to market. To overcome this gap, a compromise on talent may be necessary, coupled with robust training programs that focus on instilling a quality culture. By bringing in individuals with the right attitude and dedication, and equipping them with the knowledge specific to CGT, we can bridge this gap and ensure that patient safety remains paramount. As we navigate these challenges, it is crucial to remember that impacting patients’ lives positively should always be the most important goal.
By addressing the skills gap and investing in the development of quality assurance talent, we can empower the cell and gene therapy sector to fulfill its potential, revolutionizing the treatment of diseases and offering hope to countless patients worldwide.
Hemish Ilangaratne
Founder, Rx Group
