Press release: Umeå, February 24, 2022. Lipum AB (publ) reports that the GMP manufacturing of SOL-116 has been successful and the drug product is now ready for aseptic fill and finish before use in clinical trials.
Lipum's biological drug candidate SOL-116 has successfully been manufactured under the regulations that apply to Good Manufacturing Practice (GMP). The manufacturing work was done by the company's partner Abzena Inc. in San Diego. For the next development step, Apotek Produktion & Laboratorier AB (APL) has been engaged for aseptic fill and finish which is the final, critical step in the GMP manufacturing of biopharmaceutical products. This is a specialized process, involving highly developed techniques, that will ensure that the product is sterile and ready for use in clinical trials.
APL that has five facilities in Sweden and about 500 employees is a leading company for contract manufacturing of pharmaceuticals on behalf of biotechnology and pharmaceutical companies.
"A significant milestone has been reached in the development of our drug candidate. We are pleased to have APL as our partner for the next step. It is also great that this work is in good hands locally at their site here in Umeå." – says Einar Pontén, CEO.
For further information, please contact:
Einar Pontén, CEO
Mobile: +46 70 578 34 95
Lipum AB (publ) is a biopharmaceutical company specialized in discovery and development of a novel treatment for chronic inflammatory diseases. The lead candidate SOL-116 is a humanized antibody designed to provide efficacious therapy by blocking a previously overlooked target molecule of the immune system (BSSL). SOL-116 is in late preclinical stage supported by solid data for the rare disease juvenile idiopathic arthritis and rheumatoid arthritis. Lipum also explores other inflammatory diseases with a high unmet medical need. The company is based in Umeå, an excellent life science cluster in Sweden. Lipum's unique approach has attracted international attention, including a major European Commission Horizon 2020 grant. The company's share (LIPUM) is traded on the Nasdaq First North Growth Market. Certified Adviser is G&W Fondkommission, email: firstname.lastname@example.org,phone: +46 8 503 000 50.