3PBIOVIAN and Eleva enter strategic GMP manufacturing and technology alliance

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Leading contract development and manufacturing organization 3PBIOVIAN and Eleva have signed a strategic alliance with the goal of collaborating on the manufacturing of current pipeline programs and potential future programs based on Eleva’s technology platform.¹ The agreement allows Eleva to secure production capacity at 3PBIOVIAN for the clinical-grade material needed to advance the company’s current programs into mid- and late-stage clinical development, according to a news release.

“With 3PBIOVIAN, we have secured a renowned and high-quality manufacturing partner to support our pipeline expansion strategy. As our current programs advance towards and through clinical studies, forward-looking planning of production capacity is a crucial success factor,” said Andreas Schaaf, PhD, CSO and managing director of Eleva, in the release. “At the same time, a range of therapeutic opportunities in our industry could benefit immensely from our moss-based expression system. The relationship with 3PBIOVIAN will allow us to increase the visibility and market penetration of our platform and offers an integrated solution to advance new programs swiftly towards clinical development.”

Eleva’s pipeline programs that will be affected include Factor H (CPV-104), a novel complement modulatory that is a recombinant version of human complement Factor H, that is currently being developed in C3 Glomerulopathy (C3G) and dry age-related macular degeneration. 3PBIOVIAN will also acquire a non-exclusive license to Eleva’s expression system. As a result of the partnership, Eleva is estimated to triple its offering of GMP production capacity for its programs based on its technology platform.¹

“We are delighted that Eleva has selected us as a partner for the manufacturing of clinical material for their current pipeline programs, including their novel complement regulator Factor H (CPV-104), which could provide patients with a much-needed new therapeutic option,” said Dámaso Molero Sánchez, Group CEO at 3PBIOVIAN, in the release. “Access to Eleva’s expression system also supports our commitment to meet the evolving needs of biopharmaceutical developers by continuously expanding our capabilities. Moss-based expression adds a valuable new dimension to our established high-quality offerings in biologics manufacturing.”

For C3G, Eleva expects to enter its Phase 1 clinical study in the first half of 2025. Clinical material for the first study was previously secured.¹ Additionally, the company’s second pipeline program aGal (RPV-001) is being developed in Fabry disease, and has already delivered promising clinical data in a Phase 1b study, according to the release.

Eleva currently has a GMP-ready platform at pre-commercial scale in its work developing a novel, moss-based expression line, with a currently production capacity of up to 2000 liters. This process is designed as a suspension cell culture suited for standard fermenter equipment. Both parties in the agreement are planning on promoting the technology platform as a novel solution for the development of complex biologics.¹

Reference

1. Eleva and 3PBIOVIAN sign strategic GMP manufacturing and technology alliance to boost capacity for Eleva’s platform and pipeline. News release. Biotech Newswire. February 4, 2025. Accessed February 4, 2025. https://www.biotechnewswire.ai/202502042606/eleva-and-3pbiovian-sign-strategic-gmp-manufacturing-and-technology-alliance-to-boost-capacity-for-eleva-s-platform-and-pipeline.html