Nordic Life Science 1
BUSINESS PRESENTATION MILTENYI BIOTEC C Our long-
term goal is to improve patient care by facilitating new scientific discoveries and translating these into clinical practice. To do this, we’re trying to identify biomarkers of response to new targeted therapies and immunotherapies, and create personalized animal models on which to test drugs, as well as further humanization for use in immune-oncology research. Basic researchers and clinical investigators are working together closely to devise new therapies against melanoma and take these from bench to bedside more quickly and more reliably. Our overall aim is to develop a new therapy intervention for malignant melanomas that are resistant to conventional chemotherapy and immunotherapy. I’m sure it comes as no surprise that one of the approaches we’re looking at involves CAR T cell therapy – it’s the current darling of immune-oncological research after all and yet, despite the hype, not a single CAR T cell approach has been approved for the treatment of solid tumors, including melanoma. Our work concentrates on bioinformatically screening known CAR T cell targets to see if they are also expressed on melanomas. To my knowledge, we are one of only two research groups worldwide adopting this approach (although for different cell surface markers). Thrillingly, research just this year has demonstrated that melanomas do indeed express certain cell surface markers that can be targeted with CAR T cells. In theory. Of course, making this a reality is a little more tricky: you need to extract T cells from your patient; you need to genetically modify them – in a GMP facility if you want your eventual CAR T cell product to be put back into the patient; you need to expand them and then put them through a number of tests to make sure they do what they’re supposed to do to the cancer cells; you need to humanize animal cells, and if you get through all of those tests satisfactorily, well then you need to have a chat with the EMA. Absolutely, but I would say that three challenges stand out as particularly significant for our lab: firstly, though we’ve been creating virus vectors for 16 years, it’s never before been under GMP conditions, and when some of your materials are normally custom-made, that can be a tough transition to make. Secondly of course is meeting the EMA’s exacting standards with respect to quality pre-clinical data. Thirdly, but by no means least, is a clinical level challenge: finding clinicians willing to perform first-time-in-man treatments. I’ve been a Miltenyi Biotec customer on the basic research side of things since 2001, starting out with just the MACS® Columns for magnetic cell separation, since I’d heard good things about them from neighboring labs. That’s why when an ex-PhD colleague who’d moved to Miltenyi Biotec told me about the CliniMACS Prodigy® , I knew we had to have one: an incubated, closed, GMP system? It was so obvious how much this would facilitate our work. The last thing we need to add to our challenges is to be held back by unnecessary manual work. What’s more, the instrument’s size means we can both expand and transduce the T cells in a single set up, and even place the finished product directly into an infusion bag to be taken to the patient’s bed. Put a CliniMACS Prodigy in a GMP lab and all you need is your starting material and virus, and you get GMP-grade CAR T cells. That’s it! It probably halves the manual effort involved. Moreover, having literal bench-to-bedside capabilities facilitates and brings momentum to our work, and a renewed positive energy to the project. My staff love it. In every way. Although we’ve been using it less than a year altogether, I can already see that the CliniMACS Prodigy embodies everything I’ve come to expect from my dealings with Miltenyi Biotec: it’s like working with another scientific collaborator – they don’t just sell, they want to develop and discover too. That also brings with it another benefit in using the CliniMACS Prodigy: Miltenyi Biotec is constantly developing the platform, so we’re already seeing a number of new plug-in options available, such as an electroporator. So if, for example, we want virus-free applications at some point, we know this kind of future-proofing is going to allow us to add new capabilities to the system as and when we need to. Combined with the ever-present availability of on-site training and QC validation for the instrument, this is particularly reassuring. Finally, of course, we’re exposed to more and more of the Miltenyi Biotec product line, which includes so much else in the GMP arena that the company feels like a one-stop shop for cell manufacturing. I feel privileged every single day to work in a lab like ours, and I know many others in our line of research feel the same. Almost everyone will have friends or family impacted by cancer at some point in their lives, and the quest to cure the incurable is an inspiring and wonderful way to give something back to society, to bring hope where none is left. Our collective work relies on the support of many different agencies, suppliers, and the general public. In amongst that, it’s critical not to forget the importance of bridging the gap between basic research and the clinical disciplines to make this vital work both easier and better. That’s why innovative products like the CliniMACS Prodigy are so important, and why I’d have no hesitation in recommending researchers at every stage to work with companies like Miltenyi Biotec, who push the boundaries of the possible with you. NLS MILTENYI BIOTEC NORDEN AB SCHEELEVÄGEN 17, 223 70 LUND, SWEDEN // PHONE: +46 46280 72 80 // E-MAIL: MACS@MILTENY IBIOTEC.SE // MILTENY IBIOTEC.SE