Race Oncology Limited announced that Laurus Labs, an India-based pharmaceutical manufacturer, has produced its first batch of bisantrene dihydrochloride, Race’s active pharmaceutical ingredient (API), to a standard that meets the quality specified under the ‘Code of Good Manufacturing Practice’ (cGMP).
The ASX-listed biotechnology company said this achievement, involving a 3.25 kg batch, marks a crucial step in Race’s efforts to ensure a consistent and high-quality supply of bisantrene dihydrochloride API.
The decision to engage Laurus Labs as the new API manufacturer, announced in Q2 2022, was driven by the need to meet the scale and quality requirements for Race’s flagship new drug product, RC220, and to support future clinical trial activities.
According to Race, the successful transfer of process chemistry knowledge, known as ‘tech-transfer,’ from the previous manufacturer to Laurus Labs paved the way for systematic optimisation of each chemistry step in the bisantrene dihydrochloride synthesis process.
This optimisation led to greater yields, higher purity intermediates, and ultimately, a higher quality cGMP-certified API.
Throughout the cGMP campaign, Laurus Labs demonstrated significant efficiencies and introduced innovative chemical processes that contributed to Race’s growing intellectual property portfolio.
Moreover, diligent efforts were undertaken to qualify and quantify manufacturing process impurities, a prerequisite for the registration of any bisantrene-containing drug product, such as Race’s RC220, under a US FDA New Drug Application (NDA).
Dr Pete Smith, executive director of Race Oncology, expressed his satisfaction with the milestone, highlighting the excellent performance of Laurus Labs during the campaign and their ability to meet Race’s clinical development and commercial API needs for the long term.
He also noted the unexpected discoveries made at Laurus Labs during the manufacturing campaign, which will further enhance Race’s intellectual property position.
”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.”
The cGMP-grade API will now be transferred to Ardena in Belgium for the manufacturing of Race’s new sterile formulation, RC220, representing a crucial phase in the drug’s development.
Additionally, Race Oncology is planning further studies aimed at Phase 3 readiness and safeguarding the newly developed intellectual property assets.
