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Berkan Unal

EU BD Director, GenScript ProBio

Kun Yin

APAC & EU BD Director, GenScript ProBio

Support companies with broad expertise are playing an important role in helping smaller firms successfully develop innovative new drugs and treatments for patients.


Developing new treatments and therapies can be a long and complex process. From concept through to therapy development, clinical trials, navigating regulatory hurdles, manufacture and marketing, all stages require extensive expertise.

While smaller companies are adept at coming up with ideas for novel therapies, and have specific expertise in some areas, a challenge lies in accessing the broader expertise to progress an initial concept through to clinical application.

This is where CDMOs (contract development and manufacturing organisations) can smooth the pathway and support the process.

Biotech start-up

Berkan Unal, Business Development Director with GenScript ProBio – the CDMO segment of GenScript Biotech Corporation – says: “We specifically help small and mid-sized biotech or start-up companies to realise their projects.”

CDMOs play a critical role in helping biotech companies to optimise processes such as clinical manufacturing which can be costly in time and resources. They have become key players in the development of medical products around the world.

Gene and cell therapy is booming globally with developing treatments dominated by cell therapies, antivirus-based gene therapy and vaccine development.

Senior Business Development Director Kun Yin points out: “The CDMO concept is not new, but with the boom in gene and cell therapy (GCT), demand is increasing.

“A lot of innovation is coming from academic spin-off companies, which have expertise in some areas such as drug targets, but may not be experts in the development process.”

Regulatory hurdles

As a CDMO, GenScript ProBio can provide a wider service, including quality control, guidelines advice, and navigating changing regulatory hurdles, particularly on GCT, to help advance therapy and drug development for smaller firms. It can also leverage talent and provide documentation as well as physical material. A CDMO can combine support from its internal team, as well as access third party expertise for a client.

Gene and cell therapy is booming globally with developing treatments dominated by cell therapies, antivirus-based gene therapy and vaccine development.

However, challenges remain in the sector with high costs of production, materials and instruments.

But the organisation is working with clients to meet these challenges within the field of drug discovery and act as a development partner to share risk and minimise the cost.

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