Alexis Bossie is the head of the media R&D team at Lonza Walkersville, MD (US) which focuses on cell and gene therapy applications. Alexis has a Ph.D. in immunology and a wealth of experience in cell culture medium development for a wide range of cell types. She has held positions in both R&D and process development over the past 23 years, contributing significantly to the company.
Benefits of Having a Chemically Defined System in Cell and Gene Therapy
One of the key benefits of a chemically defined media system for cell and gene therapy is that it reduces the lot-to-lot variability of the medium and the costs associated with testing and securing fit-for-purpose raw materials. The more consistent performance of the medium translates to more predictable responses from different sources of the cells.
Chemically defined components are produced in large quantities, making them more readily available and reducing the chance of backorders compared to non-defined ingredients. Suppliers will increase their output as more people adopt chemically defined systems, potentially leading to even greater cost savings.
Being change-ready and excited by uncertainty is vital for anyone entering the industry at this point
Industry Challenges
Despite the significant benefits of cell and gene therapies, finding ways to make them affordable and widely available remains a major challenge due to the high cost of development and production. Additionally, the cost of conducting clinical trials and bringing products to the market is quite high. The pandemic has caused problems for manufacturers, including a shortage of raw materials, constrained production capacity, and overloaded logistics in the supply chain. These problems have highlighted the need for cell and gene therapy developers to reduce the complexity of manufacturing processes and streamline operations to enable the clinical success and financial feasibility of these vital treatments.
Evolving Cell and Gene Therapy Space
I foresee a steady acceleration in the number of cell and gene therapies entering the market in the coming years. Based on current manufacturing costs, however, access to these therapies may be limited to first-world populations. To enable equitable worldwide access, the industry must find ways to reduce development and manufacturing costs. Scaling up – not out – will be part of that. However, reducing the overall manufacturing cost will require developments at every step along the way. When it comes to innovation, the road ahead looks positive, with numerous cell and gene therapies being developed that could transform the way we treat and potentially cure certain diseases. I’m excited to see how we can get there.
Advice for Budding Professionals in This Field
Cell and gene therapies are undergoing such rapid change that it is imperative to remain adaptable, observe the ever-emerging new developments coming from academia and translational research arenas, and constantly learn about all new therapeutic applications. Through our educational system, we have a natural inclination to shape ourselves in a singular direction, but the ability to adapt quickly as these fields evolve is very important. Being change-ready and excited by uncertainty is vital for anyone entering the industry at this point.
