Injectable Hydrogel Enzymatic Degradation Testing
Project Description
URGENT
Contract Laboratory needed for injectable hydrogel testing. To meet the requirements of the new regulation on medical devices, we need to characterize the degradation profile of the main component of our injectable hydrogels, which is hyaluronic acid (crosslinked and non-crosslinked).
Are you familiar with the type of assays that are required? In any case, I leave you with an extract from the applicable standard, UNE-EN ISO 10993-9:2022, specifically what is said in Annex A: The relevant degradation data may include information on the degradation mechanism, the speed of degradation, the identification and amount of degradation products, and the shape/size of the particles and their distribution.
Which of the tests that you carry out is appropriate to meet these objectives? We think that it would be reasonable for the tests to be carried out using fibroblast cultures, our products are injected in the dermis.
If so, could you give us more details about the protocol, the conditions and, above all, the results that are expected to be obtained?
Another aspect that we would like to specify is the number of control points that could be recorded. The trial would last up to 30 days, taking an initial control point and another one at 30 days. For us, it would be very interesting and informative to include more intermediate times such as 1, 3, 7 or 10 days. Could you confirm this? The more points the better, so we would have more solid results, also taking into account that we have to extrapolate the curve in some cases up to 90 days.
In relation to this, we have another question: would it be possible to make a repetitive exposure? That is, subjecting the same test sample to product exposure once at time 0 and again at time 7 days (this intends to simulate the weekly injection sessions that are part of the usage protocol for some products).
Lastly, we have a lot of urgency to carry out these tests, so we would be grateful if you could clarify these doubts for us soon so we can start as soon as possible.
Project Information
Number:22-02864
Industry:Pharmaceuticals
