CDMOs (contract development and manufacturing organizations) are facing challenges due to the increasing number of companies preparing to scale up their cell and gene therapy manufacturing for Phase III trials and commercialization. While physical capacity has been blamed, the real issue lies in the lack of experience.
Manufacturing novel products requires process innovation, but advanced therapies pose unprecedented challenges compared to the early days of monoclonal antibodies in the biopharmaceutical industry. Despite rapid growth, standardization remains distant. SMEs must partner with CDMOs to quickly scale by utilizing manufacturing capabilities and knowledge.
Despite new manufacturing players and investments in capital expansions, SMEs are unhappy with their CDMOs due to the lack of experienced personnel. The high demand has led even industry leaders to depend on inexperienced staff, causing issues. Training new staff for cell and gene therapy manufacturing takes a significant amount of time, and high turnover worsens the situation, particularly in biotech hubs where job switching is common. Insufficient training results in avoidable errors and basic mistakes.
Inexperience is not only a concern on the clean room floor but also in the guidance provided by CDMOs to developers. New companies in the field rely on their CDMO partners for guidance, but a common issue is that inexperienced SMEs underestimate the time needed for scaling up, leading to overwhelming situations. Moving too quickly without proper preparation is detrimental, making experienced CDMOs valuable in setting the right pace and ensuring thorough process development prior to clinical trial scaling.
Since the industry is relatively young, SMEs seek partners with specific expertise in areas such as preferred vectors or cell types. While the developer may contribute certain assays or novel aspects of the manufacturing process, they acknowledge that they don’t have all the necessary pieces. Thus, they aim for a balanced approach between outsourcing and insourcing manufacturing. However, recent industry turbulence has led to smaller specialized companies being acquired by larger ones, which can result in clients being deprioritized.
The right partner is crucial for successfully delivering new medicines to patients, while the wrong partner can cause numerous problems. CDMOs’ reputations precede them in the insular industry. A single mistake can be disastrous for small companies, while larger ones may have better safeguards. Successful CDMOs prioritize maintaining relationships by promptly addressing issues openly.
SMEs often struggle to receive the same level of attention from service providers as larger players do. Therefore, it is crucial to collaborate with a CDMO that values its business. A CDMO’s commitment to a product is evident through early engagement in developing a chemistry, manufacturing, and controls (CMC) strategy and a strong emphasis on process development. These capabilities are essential, but many CDMOs merely pay lip service to development while focusing on profitable pivotal clinical trial manufacturing. Companies going through the CMC process for the first time without an established path forward can face challenges.
Conversely, an experienced CDMO demonstrates their understanding and execution of the pathway forward. Developers can assess this by the questions asked and the CDMO’s comprehensive experience across the entire manufacturing process. A strong multidisciplinary team ensures adherence to regulatory quality standards without mistakes. Half the capabilities are not enough for a successful partnership.
Considering a CDMO’s location is important when evaluating its staff. Busy hubs often experience intense competition for talent, resulting in overpromotion and title inflation in rapidly growing sectors like advanced therapies. However, CDMOs located near reputable universities and with access to public apprenticeship programs indicate a stable talent pool. Given the scarcity of talent, it is worth considering a partner’s company culture. In cell therapy manufacturing, strong teams are composed of experienced leaders and implement effective recruitment and mentorship programs to cultivate emerging talent.
Part of industry growth comes from SMEs choosing to build or buy their own manufacturing capabilities due to a lack of trust in partnerships. However, this solution harms the entire industry. CDMOs need to improve their expertise and transparently describe their capabilities. SMEs should evaluate potential CDMO partners based on reputation, experience, and understanding of their needs. It’s important to find a CDMO with the right culture for success.
