I Heart Gemini’s Medical Devices

Blog entry

Yep. You read that right. Gemini has medical devices. Who knew? Well, they did and you might have even used them and if you haven’t you may want to consider them. Allow me to explain:

Once researchers figured out how to make different cell types from human cells, it didn’t take long before people understood the potential for cell-based therapies. In turn, it also didn’t take long to recognize the inherent dangers of growing potential life-saving cells in conditions that could hurt the very people they intended to help. One hurdle that researchers must overcome is bypassing the use of animal-based products (think serum, growth factors, supplements, etc.). While the answer may seem simple (use human-based stuff!), it goes much further than a few catalog item switch-outs. One unanticipated immune response can not only end an expensive clinical trial, it can be incredibly dangerous to the patient. Most media will need to be serum-free and free of many of the non-human components that cell researchers rely on, like BSA.

Right. So this medical device business I mentioned above? Scientists, clinicians and other experts realized the need for standardization and consistency with anything that can be used to treat people. But before we go around and open up your roadside therapy stand, we need to ensure a few things. Of particular importance is whether your media and components come from a Current Good Manufacturing Practices (CGMP) compliant source. While these guidelines have been around since 1978, it’s only relatively recently that this need has made it into the cell therapy/regenerative medicine world. So if you harbor hopes that your cells will eventually make it into a human, you’ll want to make sure your media and supplements are manufactured under these guidelines. Without it you’re taking an unnecessary risk and pretty much ensuring that you’ll need to repeat your experiments.  Think about it: Here you are, staring into your microscope and all of a sudden you say to yourself, “Cripes! I think we figured it out!” before going to chat with your PI. The next thing you know, you’re running a spin-off biotech on your college campus and everyone’s watching you… everyone. Which means you’ll be scrutinized, poked, prodded, and generally regulated by governing bodies, who will ask about your CGMP certifications. And, if you look at them and say, “CGM whatty what?” your budding biotech is, at best, stalled in its mission to rule – I mean, change –  the world and, at worst, dead in the water.

But fear not, dear scientist! The good folks at Gemini have the know-how, experience, and the chops to get you where you need to be: Growing your cells in conditions that are conducive to potential eventual human use. They have the certifications and the documentation to back up their claims. If the stuff is good, your cells will be good, and your biotech company will get bought out by big pharma! I mean, your biotech company will change the world! 

Gemini will work with you, identify your needs, and help take the headache out of working with those regulatory bodies that keep insisting on seeing your notebooks. They’ll happily provide documentation and certificates along with their CGMP-compliant media and supplements. Saving the world is hard work. So, the next time you think you’re getting there, make sure you think about Gemini’s Medical Devices and how they can get you to where you need to be!

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