Contract manufacturer Biovitrum has been asked to undertake process development and clinical trial manufacturing of the biologic drug (RES 08) by its developers, Resistentia.

According to Marcus Bosson, CEO of Resistentia, Biovitrum was chosen due to its "vast experience with process development for Phase III biological clinical materials."

"We have both process development and manufacturing capabilities for biologic drugs – this capability is unique in the Nordic area – the only other contract manufacturers to offer this nearby are large firms within mainland Europe," Biovitrum spokesperson, Anna Karin Källén added.

Over two years has been allocated for the new project, the bulk of which will be focused on the process development phase.

"I expect the process development phase to take at least 18 months and the manufacturing component to take a further three months," Marcus Bosson, CEO of Resistentia, told In-PharmaTechnologist.com.

The new inflammatory drug is Resistentia's lead compound that is a recombinant fusion protein (a protein with a compound structure produced by biotechnical methods) that is intended for the treatment of immunoglobulin-E (IgE)-mediated allergies.

With the onset of an allergic reaction, allergy antibodies called IgE are formed against the specific substance that caused the reaction, such as pollen, dust, etc.

Resistentia claims that RES 08 blocks the effect of IgE and thus prevents an allergic reaction.

Phase I studies of the drug are due to begin in New Zealand in February and Phase III trials are earmarked for the end of 2009.