Topical delivery from concept to market

A full service CRO, Zelmic's focus is on the local delivery of small molecules, peptides and proteins. Zelmic provides support from drug discovery, through formulation and all stages of clinical trials, to generation and maintenance of intellectual property. Zelmic has a European focus, with a lot of companies across the Nordic region.

Founded in 2003, Lund-based contract research organisation Zelmic works with pharmaceutical companies to find better ways to deliver their drugs across the skin and mucosa.
"Our aim is for innovative product design and development for our clients," said Anna Holmberg, CEO and project manager. "Since we started we have taken two topical products from idea to clinical or preclinical testing each year."
Zelmic was founded by Åke Lindal, chair and senior scientist, David Sagna, head of development, and Holmberg, who have more than 60 years' experience in pharmaceutical development, problem solving and innovation.
"We understand that all products come with their own specific requirements and challenges, and to be able to provide this we need to understand the disease that the product is targeting. We can achieve this because we have an excellent team with experience and expertise in oral, parenteral and dermatological areas, and in formulation development, analytical chemistry and handling intellectual properties, and these are supported by well-equipped laboratories," said Holmberg.

Developing the right formulation
Formulation can have a major impact on the effectiveness of a topically-delivered drug, and the earlier the formulation is decided, the smoother the development of the drug, and the less likely the need for repeating preclinical and clinical studies. Topical formulations for the skin also have to have the right cosmetic properties.
"The formulation needs differ with each drug and therapeutic indication. We are good at delivering drugs where they need to be," said Holmberg. "We can also offer companies support in creating an IP strategy and gaining patents for the innovation provided by the combination of the drug and delivery system."
As an example of the IP opportunities offered by Zelmic's delivery solutions, Pharmiva, also based in Lund, was created around a Zelmic system that delivers a foam in clinical developed for antibiotic-free treatment of bacterial vaginosis.

Making the most of performance testing and analytical chemistry
In vitro performance testing – looking at formulation stability, the release of the drug from the formulation and drug penetration characteristics – is a critical part of developing a topically delivered drug. Zelmic uses diffusion and flow through cells to assess release, and synthetic membranes and human and animal tissues to predict penetration through mucosa, skin and nails. With these techniques we also can evaluate skin metabolism and local irritation. In addition, Zelmic will help companies develop and verify their analytical methods to monitor the drug, the product, and its impurities or excipients.
"While many CROs offer stability studies, adding in release and penetration assessments makes us different. We believe that we offer the most in depth and cost effective topical performance testing available," said Holmberg.

Manufacturing services
Zelmic has collaborations with a number of commercial GMP manufacturers for clinical trial manufacturing, and will performs tech transfer to a suitable site.
"We plan to expand our services to GMP stability and GMP release analysis," said Holmberg.


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Näringsliv 2018-4

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