Case Study: Accelerating a Product Pipeline with Early Phase API Synthesis

In a bid to accelerate its product pipeline, a Scandinavian drug development firm approached Onyx Scientific as it required a contract research organisation (CRO) to assist with its early phase API synthesis requirements.

Dave Lathbury, chemical development consultant, working on behalf of the drug development company, explains the background: “The client is developing a drug in the CV space. As such, they required support for a pre-clinical and phase I project ideally from a CRO with a strong track record in small scale API development and GMP manufacturing”.

“Having worked with Onyx on various chemical synthesis and development projects at my previous role at AstraZeneca, I knew they could be a good fit for the needs of the client. I spoke with my former colleagues who verified that Onyx was as good as ever and my decision to get in touch with the team was made.”

As the companies entered early discussions, the team at Onyx Scientific was quick to identify potential complications and hurdles on the horizon.

Dave said: “We were really impressed with Onyx’s ability to consult on day one rather than just take instructions. This was demonstrated in initial dialogue and the technical team’s attention to detail.

“We were instantly impressed by the speed at which our project was progressing. The team’s knowledge of the chemistry and ability to come up with solutions to overcome a potential development hurdle confirmed we had made the right choice of partner.

Once the project was well underway, a salt screen and compound resolution was carried out during the drug product stability phase, helping generate invaluable additional information on the compound.

Dave added: “Having the chemists running the project and reactions present throughout gives us access to real-time information and allows things to move quickly. We have found the team at Onyx very open, informative and able to provide solutions to any unforeseen issues.

“In particular the ability to shorten the synthetic route and obtain a highly effective resolution has impressed the client. Onyx has a pragmatic approach without too much administration involved. It felt more like a collaboration than a client-vendor relationship.”

The work by Onyx has enabled the client to progress the development of its products towards a Phase I trial.

Dave concluded: “Having a high level of chemistry expertise is one thing but being able to combine this with a problem-solving attitude, an ability to proactively generate new solutions and strong communications skills is what makes Onyx a standout CRO and drug development partner for companies ranging from virtual firms to big pharma.”

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