He is zooming in on topical preparations

According to Zelmic CEO David Sagna, topical products in drug development is a growing market, and to keep pace with the development, the company is awaiting approval for its new GMP facility.

When Zelmic was founded in 2002, the company developed its own products, but in recent years it has focused on assisting customers with the development of topical and transdermal pharmaceutical formulations. The strategy is to build up the projects, find the methods and manufacturing methods and ensure that the projects become scalable. 

When speaking at Life Science Sweden’s Pharma Outsourcing event in December, the company’s CEO, David Sagna, will emphasise the importance of finding the right partner early in product development.

“Topical products in pharmaceutical development are a growing market. Not having to treat the whole body is a huge relief for many patients with chronic diseases. I will talk about the importance of finding the right partner in developing the product and that the partner has the right model, methodology and knowledge.”

The company has recently built a GMP facility for clinical manufacturing. The Swedish Medicines Agency has inspected it, and the hope is for it to be approved by 27 November. The facility is a crucial piece of the puzzle for the company’s development, but it also opens up new business opportunities as it enables the company to reduce the time it takes to get to the clinical phase.

“We have built a facility to pass class C, but it will be classified for class D. It should be able to accommodate customers in the first clinical studies, phase I and II studies. Depending on the project we take on, we can adapt it to small-scale manufacturing, as it is manual to semi-manual. It is a fairly large investment that we have been working on for one year,” says David Sagna.

In his opinion, keeping up with topical pharmaceutical formulations is extremely complex.

“You have a limited number of excipients to work with, and the tricky part is to get high enough solubility to be able to scale up the dose and reach delivery. Finding a solution requires some creativity and understanding of the chemical aspect.”

He adds:

“You want penetration, build-up of the depots and a stable product. This is extremely important, and we are focusing heavily on this early in the project. We don’t want to trick the customer into a formulation project that ends up dying because it is unstable.”

Although the effect of the medicine is the primary focus, the patient’s experience of the cream with the medicine is also a crucial factor.

“It must not stain or rub off on clothes, discolour or smell bad, and it must also be easy to rub in. For many of the patients, this is a lifelong treatment, so these tactile features are extremely important to consider in an early phase.”

David Sagna is one of the speakers at the Pharma Outsourcing event on 1 December in Stockholm.

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