GMP challenges holding back Big Pharma's personalised vaccine uptake, says immatics

By Dan Stanton

- Last updated on GMT

GMP challenges holding back Big Pharma's personalised vaccine uptake

Related tags Big pharma Vaccine

Biopharmas struggle to comply with GMP requirements for personalised meds and the outstanding questions mean some are reluctant to invest according to German firm immatics.

Tuebingen-based immatics Biotechnologies is part of the Glioma Actively Personalized VAccine Consortium (GAPVAC), which is a 16-strong group of companies working to advance a novel class of fully personalized therapeutic cancer vaccines into trials for glioblastoma, an aggressive form of brain cancer.

The project, which is supported by a €6m ($8m) EU grant, is necessary according to CSO Harpeet Singh because although the science of personalised drugs is well established, commercial-scale production of such drugs is still a challenge.

“GMP Production is cost-intensive because of the regulatory requirements, particularly related to various in-process and post-process controls and extensive documentation,”​ he told Biopharma-Reporter.com.

In response, GAPVAC has set up a special unit to deal with the problems of certifying GMP for such drugs in collaboration with the University of Tuebingen.

The University, which will make vaccines for Phase I and II trials, uses standard solid phase technology for peptide manufacturing, Singh said, explaining that the challenge is to perform such production at a very small scale under GMP conditions.

“There is no commercial provider who does such extensive work on low scale for individual patients. This is why our partners at University of Tuebingen decided to build their own facility. And it works.”

Personalised trend

Recently, preclinical services firm Horizon Discovery told our sister publication Outsourcing-Pharma.com​ that Big Pharma firms are turning away from large volume drugs to personalised biopharmaceuticals.

However, while Singh agreed with the idea that “Big Pharma has started understanding that the whole field has to move into stronger personalizations,”​ he said ongoing GMP questions and industry relsistance to change mean personalised therapies have yet to be fully embraced.

“It’s the same in the energy sector where we see shifts from centralised to decentralised infrastructures which the big energy providers are not really happy with,”​ he told us.

However, there has been some progress: “Two years ago, no one would have dreamt that Big Pharma would do autologous adoptive cell therapy. Now this has shown first dramatic changes in cancer treatment - CD19 CARTs for example - and as Novartis has moved into this space​, the others are following.”

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