Onco-Innovations Limited (CBOE CA: ONCO) (OTCQB: ONNVF) has successfully completed its analytical reference standard preparation program for A83B4C63, the active pharmaceutical ingredient (API) supporting its lead oncology candidate, ONC010. The program, conducted in collaboration with Dalton Pharma Services, established a qualified reference standard to support analytical testing, manufacturing consistency, quality control, and future regulatory and clinical activities.
This milestone strengthens the company’s chemistry, manufacturing, and controls (CMC) framework, following recent progress in API manufacturing, precursor scale-up, analytical method development, and chiral purity testing. Onco-Innovations stated that the reference standard program supports its broader strategy of advancing ONC010 toward clinical readiness, while ongoing analytical development efforts continue across stability testing, impurity profiling, formulation characterization, and quality control systems.
The completion of the reference standard is a critical step for any pharmaceutical candidate, as it ensures that the API can be consistently identified and quantified during manufacturing and testing. This is essential for meeting regulatory requirements and for the integrity of clinical trial data. For a company like Onco-Innovations, which focuses on novel cancer treatments, this development moves ONC010 closer to potential patient use.
Onco-Innovations is a Canadian-based company dedicated to cancer research and treatment, specializing in oncology. Its mission is to pursue the prevention and treatment of cancer through pioneering research and innovative solutions. The company has secured an exclusive worldwide license to patented technology that targets solid tumours.
For more information on the full press release, visit https://ibn.fm/EefIN. The latest news and updates relating to ONNVF are available in the company’s newsroom at https://ibn.fm/ONNVF.
