Outsourcing up for GMP APIs as Onyx completes manufacturing deal
Onyx assisted with the production of a 1kg batch of API that was used in Neuronascent’s pre-IND (investigational new drug) submission to the US Food and Drug Administration (FDA).
The company looks forward to “potentially” working again with Neuronascent on the next phase of its project, involving the GMP production of API to support clinical trials, Denise Bowser, Commercial Director, Onyx, told Outsourcing-pharma.com.
The CDMO is seeing an increase in demand for Phase I GMP (good manufacturing practice) campaigns, she said, “mainly from our UK-based biotech clients.”
As well as manufacturing for this project, Onyx performed “general process improvements such as improved purification and efficiency throughput improvements,” added Bowser.
Neuronascent’s lead candidate is NNI-362, a small-molecule therapy aimed at Alzheimer’s and Parkinson’s disease and other neurodegenerative disorders.
Client: ‘funding constraints’
Judith Kelleher-Andersson, Neuronascent’s President and founder, told us she had chosen Onyx for the manufacturing project because the CDMO was “willing to provide a quote without having already synthesized the compound, which saved time and money” for the small biotech company.
“The difficulties for a small company are indeed funding constraints, always,” she continued. “It is important to complete the synthesis and keep within the set budget, even though Onyx Scientific probably did not make as much money as [it] might have, if you counted hours and effort after the fact.
“The purity is critical for us even though it was not GMP [good manufacturing practice]. [Onyx] ensured that it also met the criteria of our government contractor, so there were changes along the way, that [the manufacturer was] able to accommodate.”
Onyx Scientific has labs in the UK delivering preclinical and Phase I-III programmes. Its commercial manufacturing sites in India then scale up, “tech transfer” and increase efficiency for API production.
