Cell therapy products using immune and skin cells for purposes such as wound healing and cancer immunotherapy are on the rise. By 2025, the FDA will likely approve 10-20 gene and cell therapy products each year, marking a huge boost to the cell therapy industry.
However, the upfront investment to build a Good Manufacturing Practice (GMP)-compatible infrastructure for cell manufacturing is significant, so many companies prefer to work with contract labs to manufacture cells. Here are a few key guidelines to choosing reliable cell therapy product contract manufacturers.
Contract labs are an ally to companies and can provide advice on best practices in cell manufacturing.
It is critical to do background research on the expertise and reputation of contract manufacturers. Their experience with previous companies, such as the cell types they are manufacturing, can be highly informative of whether they can work with the cell types you need for clinical trials. Contract manufacturers can play an active role to advise on the manufacturing processes, including the types of media composition to use, the quantities of viruses to add for genetic engineering, and the type of bioreactors to use for scaling up cell expansion. Experienced contract manufacturers can refer to successful manufacturing protocols from other clients and help you avoid common pitfalls.
Networks of contract manufacturers
Contract labs do not cater to all clients across the entire clinical phase and instead specialize in clinical phase 1/2 or phase 3. This means that customers will most likely need to switch contract labs when they move into different clinical phases, which can be disruptive as manufacturing processes might need to be re-optimized. Choosing contract labs with a good network of other manufacturing partners can help to minimize such disruptions as they can refer you to reliable partners.
Meeting regulatory standards
It is useful to discuss with contract manufacturers their procedures to ensure that they meet the highest regulatory standards, such as how they track the transport of cells from patients to the cell manufacturing facility and back. They can even help prepare supporting documents for submissions to regulators. This can be a significant benefit, especially in cases where a cell therapy product leads to adverse patient outcomes.
Experienced contract manufacturers can refer to successful manufacturing protocols from other clients and help you avoid common pitfalls.
The average price of a cell therapy product is $300,000-$500,000/dose, putting it out of reach of many patients. A study has found that this hefty price tag is due to high manufacturing costs including the use of highly specialized labor and expensive reagents. For start-up companies trying to provide more price competitive cell products, costs will be a key consideration. Contract manufacturers that are working with many clients may be able to exploit economics of scale or invest in automation to reduce labor costs. Furthermore, they also have an advantage in negotiating for better price points as they purchase raw materials in bulk.
Contract labs are an ally to companies and can provide advice on best practices in cell manufacturing. Choosing the right contract lab partners will enable companies to successfully produce cells for clinical trials and move their products from the lab to clinics to ultimately benefit patients.