Race Oncology (ASX:RAC) has announced that Laurus Labs (has successfully produced its first batch of bisantrene dihydrochloride.
Laurus is manufacturing Race’s active pharmaceutical ingredient, Bisantrene, to a standard that meets the quality specified under the ‘Code of Good Manufacturing Practice’ (cGMP).
Race announced that it had selected Laurus Labs as its new API manufacturer in April 2022.
The company said the decision was made to ensure the continuity of supply of bisantrene dihydrochloride API at a scale and quality suitable for use in its flagship new drug product, RC220, and support future clinical trial activities.
Race executive director Dr Pete Smith said, “Completion of the first batch of API at our new Contract Manufacturing Organisation (CMO), Laurus Labs, and its certification of cGMP quality, is an important milestone for Race. Laurus Labs has performed very well during this first campaign and has the capabilities and capacity to provide our clinical development and commercial needs for API over the longer term.
”We have sufficient active pharmaceutical ingredient for our RC220 cGMP drug product manufacturing program and near-term clinical trials. As an unexpected bonus, there have been some discoveries made at Laurus during the manufacturing campaign that can add to our overall intellectual property position. We look forward to continuing our productive relationship with Laurus.”