Cell and gene processing moves forward through ‘experiential learning’
The growing prevalence of cell and gene therapies in both the clinical and the commercial side of the biopharmaceutical industry is leading to increased demand for viral vectors, with companies within the contract manufacturing sector building their capacity to meet clients’ needs.
BioPharma-Reporter (BPR) spoke to Colin MacKay (CM), CEO of viral vector manufacturer Symbiosis, about how companies in this sector are addressing the rising demand, how the lack of capacity is affecting the industry, and what are the other challenges that manufacturers face.
MacKay told us that the demand needs to be addressed with improved technical expertise, but the industry is learning ‘experientially’ on how to deal with these new technologies.
Moreover, he explained how adding capacity has to come concurrently with ensuring compliance to regulations, and how the inherent biological nature of these products, and the sensitivity and complexity of their production systems, needs to be put under the spotlight.
BPR: What are the current challenges in viral vector manufacturing?
CM: The positive regulatory climate with regards to the approval of viral vector-based biopharmaceuticals is further fueling focused investment across the industry in drugs of this nature. In essence, the technology has been vindicated in a commercial setting. Although point-of-use pricing remains a contentious talking point, regulatory, technical and commercial tail-winds are driving the industry to adapt in many ways, and to do so quickly. With respect to manufacturing, for example, there is strong demand for both drug substance and drug product manufacturing, while CMO’s like Symbiosis continue to invest in additional manufacturing capacity in direct response to that demand. With high demand, and relatively smaller supply, the foundation is laid for the value of strategic relationships to be realized and to gain prioritized access to manufacturing capacity, for example, while the commercial successes of those CMOs is providing relatively easier access to both internal and external financial resources to further grow overall manufacturing capacity.
Challenges include balancing supply versus demand for a growing business while ensuring that the competitive strengths that come from short lead-times to access manufacturing slots, for example, is positioned to support the accelerated development timeframes which drug developing client companies are working to.
BPR: How have the demands of the cell and gene therapies development market evolved during the past year?
CM: The successes of cell and gene therapy products being approved for market and their breathtakingly positive therapeutic impact on patients has, I believe, driven the market to evolve quickly. The overarching commercial driver in our industry – to take investors’ dollars and to develop innovative and profitable new medicines – is undiminished, and indeed has been amplified in niche sectors, such as cell and gene therapies.
In tandem, technology platforms are being validated, meaning that multiple further drugs in companies’ pipelines are being accelerated down the ‘previously ploughed furrow’ of those pioneering therapies which went first. That is fueling demand for all services which support the development of cell and gene therapies and the appetite of investors to finance the profitable growth of those service providers.
BPR: What is the main challenge that cell and gene developers face?
CM: The technical challenges of developing, and then robustly and reproducibly manufacturing cell and gene therapy products to GMP is a major challenge, principally due to the inherent biological nature of these products and the sensitivity and complexity of their production systems.
Access to manufacturing capacity, particularly amongst the bigger CMO players, is challenging clients and their drug development timeline planning.
BPR: How does the CMO industry assist developers in overcoming technical challenges?
CM: The experiential learning in the industry, with respect to the technical and GMP manufacture of both drug substance and drug product, continues to grow and that learning is being reflected back into overcoming the principal technical challenges the industry faces. Processes are being refined and optimized to improve yields and productivity, making the development of biopharmaceuticals faster and relatively more cost-effective.
BPR: How do you see the current lack of capacity in the CMO industry changing?
CM: My understanding is that access to manufacturing capacity, particularly amongst the bigger CMO players, is proving a challenge to customers and their ability to achieve their preferred drug development timelines. The industry is responding and investing significantly in building new capacity, and new drug (vector) substance manufacturing capacity.
The relatively smaller CMO players, such as ourselves, are strategically working hard to increase in-house manufacturing capacity while doing so in a measured way to ensure continued compliance in line with that growth, while investing in strategic relationships with existing clients to ensure they have access to our capacity to align with the increasing manufacturing requirement of their maturing products.
In tandem, we are adding new capacity output from our existing manufacturing infrastructure, allowing us to continue to add new, high-value, clients to our existing client portfolio who can use that growing capacity. Strategically, and competitively, Symbiosis is therefore well-positioned to provide sterile GMP manufacturing capacity to clients who are experiencing frustrations with the wider industry and its lack of manufacturing capacity and access to it on a short timeframe.