With Jorg Thommes, Head of CMC, Bill & Melinda Gates Medical Research Institute
Ultimately, stainless steel has proven to be highly reliable for the manufacture of biopharmaceutical products. Stainless teel systems are operationally robust and straightforward to maintain. The industry is familiar with the equipment and has spent a lot of effort to understand the cleaning and sterilization of stainless steel bioreactors. In addition, scale up is by now quite predictable due to excellent progress in understanding mass transport and mixing phenomena in these reactors.
It’s also true that single-use has advantages that may appeal to many manufacturers. Ease of product changeover is a significant benefit. Likewise, for a portfolio of diverse commercial products that all require only a few batches per year (for example, a rare disease product for a small patient population, or a highly potent compound), single-use may be the logical choice as it reduces the turnover time between products. Single-use also has other advantages; as the systems are oftentimes smaller, they are usually easier to transport.
It is not about which option is “superior”, it is about choosing the right solution for a specific problem.