Contrary to what many may believe, substances in topical formulations can be just as advanced as they are in any other pharmaceutical application. In addition, the introduction of new guidelines and Medical Device Regulations (MDR) has further increased the need to test and verify the effect of all medical devices, including topical formulations.
Adding GMP manufacturing for clinical trials
In recent years, Zelmic has kept pace with growing industry demands by developing and strengthening its operations to meet new requirements within Good Manufacturing Practice (GMP). As a result, the company has implemented GMP for both its analytical chemistry laboratory and its in vitro release laboratory since 2019, and can today offer advanced in-vitro performance testing according GMP and in accordance to new draft Guidance from EMA.
Now in 2022, in connection with its celebrating 20 years in Lund and Medicon Valley, Zelmic is taking another big step by establishing a completely new GMP facility for in-house manufacturing of topical formulations for clinical trials.
“The new facility will transform us into a one-stop shop for our customers”, says Zelmic co-founder and CEO David Sagna. “It will enable us to meet all their needs from the early development phase all the way on to the first clinical trials.”
“Soon we will be able to take on much more extensive assignments where we are responsible for the entire development process as well as for taking the project more quickly into the first clinical phases. This is something that we, and our customers, have been looking forward to for a long time.”
First choice in topical drug development – and manufacturing
According to Sagna, Zelmic strives to be the first choice as a local development partner for topical treatments, and in the near future also for manufacturing topical formulations for clinical trials. Investments in new state of the art equipment, as well as the hiring of new staff to focus solely on quality, are part of those efforts.
“We are still a small player, but a strong position in our field combined with very specific expertise in topical formulations is, we believe, a big advantage for prospective customers. Over the years this has enabled us to rescue many projects brought to us after failed attempts by others in the industry to move forward. So this is an exciting opportunity both for our customers in the region preparing for clinical trials, and for us as a niche CDMO,” concludes Sagna.