The following is an excerpt of an article I wrote that was originally published in the October 2016 issue of The Medicine Maker.
Some companies still fail to look beyond science and clinical need. In the most heartbreaking of cases, clinical success is followed by commercial bankruptcy. When a company is focused on clinical trials,it’s common to put off thinking about commercialization aspects, such as cost of goods, scale up, or sustainability of the supply chain. I call it the Scarlet O’Hara (or Gone with the Wind) syndrome – “Tomorrow is another day.” Unfortunately, tomorrow can be too late, particularly with cell therapies. Traditional biopharmaceutical medicines are known for their complexity, but cell therapies are even more difficult. If you address manufacturing needs too late and then find that you need to change the process to make it economically viable, you face a huge risk with regard to comparability of products made by the original and new processes. You don’t want to have to change the process to ensure profitability only to find that you must repeat your clinical trials.
It’s important to perform a strategic manufacturing assessment by reviewing the business goals for your product and identifying areas that can be invested in immediately, and areas where investment can be delayed. For example, perhaps risks can be managed by creating a manual process that will suffice for the time being, but is readily automated with low comparability risk later on. This means that you can put off investing in commercial technology until you’re confident that the product works.
At some level, each company’s cell therapy process will be unique, but there are also many commonalities. When it comes to personalized cell therapies, there are typically three general pieces to the process. First, you take a sample from the patient and isolate the cells of interest. Second, you expand or transduce those cells (or both) to transform them into cells that can have a clinical effect. Third and final, you wash and formulate the cells so that they are ready for clinical use.
Each part of the process may be relatively simple or very elaborate depending on the therapy. When I’m working with a client, I perform a technology landscape analysis to identify all the available technology that’s relevant to the situation. It’s not necessary to re-invent the wheel, so if we can find something suitable in the market then we’ll bring it into the process. However, available technologies have not addressed all needs in cell therapy manufacture, which is why we’ve been developing our own programmable cell processing system that incorporates automation, integration, and closed system design. There are a certainly a lot more cell therapy manufacturing systems available today than there were 10 years ago, and given the recent interest in clinical success stories, I think vendors now know that there is a big market opportunity to develop and market cell therapy manufacturing systems. I hope we see more systems focusing on a closed design and built on automation and integration.
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