In this episode of Exceeding Your Benchmark, Sumit Verma, Senior Vice President Global Strategic Manufacturing at Iovance Biotherapeutics, talks about the challenges faced by new biopharma startups and how cell and gene manufacturers can scale to meet demand. Verma discusses how products are tailored for each patient and how this personalized therapy requires more time and effort in comparison to traditional drug manufacturing. He also talks about how the team at Iovance Biotherapeutics worked collaboratively to find ways to optimize the manufacturing process, reduce the turnaround time, and develop products for FDA approval.
How Can Cell & Gene Manufacturers Scale to Meet Demand?
Collaboration is key for success
Collaboration is key for success. This is a lesson that Sumit Verma, Senior Vice President Global Strategic Manufacturing at Iovance Biotherapeutics, has learned through his experience in building a new facility and team from scratch. As a biopharma startup, the company has faced a number of challenges in bringing a new cell and gene therapy product to market.
One of the biggest challenges is the new wave of drug manufacturing. Cell and gene therapies are tailored to each individual patient, meaning that one patient equals one batch. This is very different from producing drugs in large batches, as is the case with Tylenol, or producing multiple vaccines from one lot. This personalized approach to manufacturing requires a significant amount of time and a number of individuals involved in the product.
Verma’s team has worked hard to overcome these challenges. They have worked collaboratively to create a forum to innovate and deliver the product for cancer patients. They have also spent a significant amount of time in the clinical setting, in the research labs and in process optimization, and have been able to reduce the process time from 44 days to 22 days.
The team also put in a lot of effort upfront in the planning and starting up phase. This included training technicians, sourcing talent, and understanding the product requirements for FDA approval. This upfront effort has paid off, as it has made the execution of the product much easier.
The experience of Verma and his team at Iovance Biotherapeutics shows that collaboration is key for success. By working together and planning ahead, the team has been able to develop a product that will bring much needed treatments to cancer patients. Collaboration and teamwork are essential for any business to achieve its goals and reach its full potential.
Just in time manufacturing is critical
When it comes to manufacturing, just in time delivery is key. This is especially true when it comes to cell and gene therapies, where every patient’s treatment is unique. In order to ensure that the treatments are delivered in a timely manner, it is essential to have a well-planned supply chain and logistics system in place. This includes having a reliable source for the required materials, as well as a plan for how to get them from various parts of the country to a centralized manufacturing space.
Verma and his team have put a lot of effort into making sure their supply chain and logistics are in order. They have focused on partnering with the right vendors and making sure they have the right components in place to scale up quickly. They have also invested in automation to ensure that they can meet the growing demand for their treatments. Automation is essential for scaling up production, as it reduces the amount of labor required and allows for a more efficient workflow.
Just in time delivery is essential for any business, especially in the cell and gene therapy industry. It is important to plan ahead and have a reliable supply chain and logistics system in place. Automation is also key for scaling up production and meeting the growing demand for treatments. By following these steps, Iovance Biotherapeutics has been able to develop a product that will bring much needed treatments to cancer patients.
Choose the right partners
The key to success in the cell and gene therapy industry is choosing the right partners. Choosing the right vendor to work with is critical to the success of any biotech company. Iovance Biotherapeutics has been fortunate enough to partner with companies like Benchmark Products, who have been able to provide them with the necessary supplies and resources they need to run their operations. The company has also worked with multiple airports in the Philadelphia area, so that if there is a delay or cancellation due to bad weather, they can still get their products to their customers in a timely manner.
In addition to choosing the right partners, Iovance Biotherapeutics has also implemented just-in-time manufacturing and inventory management. This means that they can quickly respond to the needs of their patients and have the necessary supplies on hand. This is especially important during times of crisis, such as the current pandemic, when supplies can be hard to come by.
In conclusion, it is essential for biotech companies to choose the right partners in order to be successful. Iovance Biotherapeutics has been successful in this regard, and their success has enabled them to bring much needed treatments to cancer patients. By choosing the right partners and implementing just-in-time manufacturing and inventory management, biotech companies can ensure that they have the necessary resources to run their operations and meet their customers’ needs.