Outsourcing up for GMP APIs as Onyx completes manufacturing deal

By Fiona BARRY

- Last updated on GMT

Outsourcing up for GMP APIs as Onyx completes manufacturing deal

Related tags: Good manufacturing practice, Clinical trial, Pharmacology

Onyx Scientific, a UK contract development and manufacturing organisation (CDMO) has completed an API (active pharmaceutical ingredient) production deal for Neuronascent, a US company developing neurological therapies.

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.

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