Wacker Chemie AG. (4/2/25). "Press Release: Wacker Biotech Announces Strategic Collaboration with RNAV8 Bio to Enhance mRNA Therapeutics Development". Munich.

	Organisation	Wacker Biotech GmbH
	Group	Wacker (Group)
	Organisation 2	Wacker Chemie AG
	Group	Wacker (Group)
	Product	biopharmaceutical production technology (biomanufacturing)
	Product 2	mRNA-based drug
	Person	Shah, Devan (RNAV8 Bio 202504 CEO + Founder)
	Person 2	Cronet, Philippe (Wacker 202201 General Manager at Wacker Biotech US Inc)

> The companies will offer complementary services for developing and producing mRNA-based therapies.

> WACKER provides pDNA/mRNA manufacturing and lipid formulation; RNAV8 offers an mRNA engineering platform.

> Engineering non-coding regions of mRNA sequences enhances drug efficacy.

> This collaboration positions WACKER and RNAV8 as premium mRNA service providers.

Wacker Biotech, a leading contract development and manufacturing organization (CDMO) wholly owned by Wacker Chemie AG, today announced a strategic collaboration with RNAV8 Bio, a Boston-based pioneer in mRNA engineering. The collaboration is aimed at progressing the development and production of mRNA-based advanced therapies for the biopharma industry.

[photo] Wacker Biotech US
As a CDMO, Wacker Biotech US Inc. operates microbial fermentation lines with a capacity of up to 650 liters for cGMP compliant production and purification of pDNA as well as pharmaceutical proteins (Photo: WACKER).

This new partnership combines Wacker Biotech’s expertise in pDNA/mRNA manufacturing and lipid nano-particle (LNP) formulation with RNAV8 Bio’s innovative mRNA engineering toolkit, which enhances the non-coding sequences of mRNA strands, known as untranslated regions (UTRs). UTRs are crucial for mRNA processing, transport, stability, and translation, and their optimization can significantly improve the efficacy of mRNA-based drug products.

The collaboration positions Wacker Biotech and RNAV8 Bio as premium providers in the mRNA space, offering a unique end-to-end service. The companies aim to provide a comprehensive solution that meets the growing demand for advanced mRNA therapeutics.

“As the therapeutic potential of mRNA rapidly expands into high-value applications across genetic and common diseases, more predictive control over mRNA function becomes critical. RNAV8’s approach represents a major advance, enabling highly efficient and/or more durable mRNA expression at potentially lower doses.” said Devan Shah, CEO of RNAV8 Bio. “With its impressive manufacturing capabilities and clear track record in mRNA/LNP GMP production for scale-up, Wacker Biotech is an ideal partner for RNAV8 and its therapeutics collaborators.”

Philippe Cronet, General Manager of Wacker Biotech US Inc., added, “We are thrilled to collaborate with RNAV8 Bio. In combination with WACKER’s nucleic acids R&D team, this partnership enables us to offer clients a top-of-the-line, market-leading solution for mRNA therapeutics optimization and manufacturing. On clients’ behalf, we will work with RNAV8 to optimize UTR non-coding sequences to maximize the expression of mRNA in the target cells. Drug developers will have enhanced abilities to rapidly prototype, test, iterate, and scale up their mRNA therapeutics. Ultimately, this holds the promise of improving drug efficacy and accelerating the development process.”

About Wacker Biotech

Wacker Biotech is a full-service contract manufacturer of therapeutic proteins based on microbial systems, live microbial products (LMPs), plasmid DNA (pDNA), messenger ribonucleic acid (mRNA) and vaccines. Wacker Biotech’s portfolio extends from strain/process development and analytical testing through to production for clinical and commercial applications. Wacker Biotech operates three GMP-compliant, FDA- and EMA-certified production plants at its Jena and Halle sites in Germany and in Amsterdam, the Netherlands. In addition, Wacker Biotech has a GMP-compliant plant in San Diego (Wacker Biotech US Inc.) that specializes in the production of pDNA, a critical starting point for mRNA therapeutics. Wacker Biotech GmbH, Wacker Biotech B.V. and Wacker Biotech US Inc. are wholly owned subsidiaries of Munich-based Wacker Chemie AG.

www.wacker.com/biologics

About RNAV8 Bio

RNAV8 Bio (pronounced “Renovate Bio”) utilizes rational design alongside machine learning and artificial intelligence techniques to engineer mRNA functions with greater predictability. In vitro and in vivo data indicate that RNAV8’s distinctive methodology has the potential to significantly enhance mRNA’s therapeutic window compared to prevailing industry standards. Consequently, the company has garnered partnership traction with leading biotechnology and pharmaceutical firms, showcasing the promising impact of their approach.

www.rnav8bio.com

Record changed: 2025-04-10