ExploRNA, Lukasiewicz–IChP Partner on GMP mRNA Cap Analog Manufacturing

ExploRNA Therapeutics and the Łukasiewicz Research Network–Industrial Chemistry Institute have formed a partnership to manufacture ExploRNA’s mRNA cap analogs to good manufacturing practice standards for use in clinical-stage mRNA therapies and vaccines.

The agreement covers ExploRNA’s proprietary cap analogs, including its AvantCap Q1 technology. The companies said the arrangement is intended to provide a GMP-grade supply of materials for biotechnology and pharmaceutical developers.

Łukasiewicz–IChP will contribute chemical-synthesis and production-scaling capabilities under the partnership. ExploRNA focuses on mRNA capping technologies, which are used during the production of messenger RNA medicines.

Co-transcriptional capping is a manufacturing step in which a cap structure is incorporated into mRNA as the RNA strand is synthesized. The cap can affect properties of the resulting mRNA, including production yield, quality and translation efficiency.

The companies said producing the cap analogs under GMP standards will allow their use as raw materials in the development of mRNA-based therapies and vaccines. GMP standards govern manufacturing systems intended to ensure materials are consistently produced and controlled according to quality requirements.

ExploRNA Chief Executive Jacek Jemielity said the partnership is intended to support the transfer of the company’s capping technologies from laboratory-scale work to clinical applications.

The collaboration is aimed at supporting mRNA developers from early research through later-stage clinical development and potential commercial manufacturing. ExploRNA said the agreement is part of its effort to make its cap analog technologies available for clinical and commercial programs.


Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers from Pharmaceutical Outsourcing - all delivered right to your inbox! Sign up now!

  • <<
  • >>

Join the Discussion