Vitrolife's product development process is tailored to ensure quality, from research to clinical use. Aligned with prominent researchers we put ideas into practise. Together. All the way.

20 years of clincial media development

Vitrolife has an extensive background, competence, know-how and track record within the in vitro fertilization area. Vitrolife is in the field of IVF committed to improving pregnancy rates and provide an unbroken chain of quality products, securing the results in every step during the whole IVF-treatment. Our infrastructure is tailored for clinical products. This same high quality approach is now transferred into our development and production of stem cell products.

Products tailored for clinical use

A clinical grade medium within the stem cell area should be produced according to full cGMP (current Good Manufacturing Practice) standards using defined components, but it should also be free from any products of animal origin. The use of animal derived components, such as fetal calf serum, FCS, increases both the risk of introducing animal pathogens into the end product and the risk of causing allergic reactions and antibody formation in patients. The media should show excellent and reproducible results, have a responsive and flexible product support and be accompanied with a complete documentation needed for regulatory clearance. In addition, the media should be possible to custom produce in volumes and sizes needed for the specific application. Current and future products produced by Vitrolife adhere to this description.

All our media are defined, serum-free, xeno free and are manufactured according to cGMP and ISO 13485 standards. Most of our fertility products have CE-mark, FDA-clearance, TGA-approval as well as approval from SFDA and Canada Health. We strive to have the same approvals for our stem cells products to ensure an easier regulatory clearance for our cell therapy customers.