Wacker Biotech and Expression Manufacturing announce strategic partnership to accelerate development of lentiviral-based gene and cell therapies

• Collaboration to offer comprehensive lentiviral vector development services – from gene to plasmids to viral vector manufacturing
• Wacker Biotech provides plasmid DNA (pDNA) manufacturing expertise via its proprietary PLASMITEC^® platform
• Expression Manufacturing contributes proprietary LentET™ platform and viral vector manufacturing capabilities
• Partnership streamlines supply chains, reduces time to market, and combines the production of proven, optimized, industry-leading plasmids and viral vectors

In response to the growing demand for high-quality, scalable lentiviral vectors crucial in advancing innovative gene therapies, Wacker Biotech US Inc., a wholly owned subsidiary of Wacker Chemie AG specializing in plasmid DNA (pDNA) production, and Expression Manufacturing, a leader in viral vector technology, have entered into a strategic collaboration. Its goal is to advance the development and manufacturing of lentiviral-based gene and cell therapies. The partnership combines the complementary strengths of both companies to provide biopharma and biotech clients with an end-to-end, optimized solution for viral vector development and production.

Wacker Biotech brings its proven PLASMITEC^® platform, which utilizes a proprietary E. coli strain to enable efficient production in as little as four months of high-quality (more than 90% supercoiled) pDNA, including transfer plasmids containing the gene of interest, as well as packaging and envelope plasmids. Operating out of its state-of-the-art pDNA center of excellence in San Diego, California and supported by sister sites in Europe, Wacker Biotech is a trusted partner for multiple drug delivery modalities.

Expression Manufacturing contributes its proprietary LentET™ platform, which features advanced lentiviral plasmid backbone technology and viral vector manufacturing capabilities. Expression’s technology is designed to enhance the safety, efficacy, and precision of gene therapy, offering features such as ultra-low homology backbones to reduce recombination risks and increase safety, and optimized coding sequences for 293T cells, a widely used cell line for viral vector production, resulting in higher potency. Expression operates a state-of-the-art viral vector manufacturing facility in Ohio, equipped with cleanrooms, production suites, and process development rooms to support the next generation of cell and gene therapies.

“Lentiviral vectors are transforming gene therapy by enabling delivery of complex genetic payloads with unprecedented precision,” said Bill Swaney, President of Expression Manufacturing. “Partnering with WACKER means we can combine our cutting-edge LentET™ technology with their unmatched plasmid manufacturing capabilities, offering our clients a seamless, fully integrated production pathway. This partnership not only accelerates timelines but substantially simplifies the path from research to patient delivery.”

The collaboration streamlines the supply chain for clients, reduces time to market, and ensures the highest quality and safety standards throughout the drug development and manufacturing process. Successfully proven through client projects, this end-to-end collaboration offers a combined synchronized platform enabling accelerated production of high-performing viral vector biopharmaceuticals.

“We are delighted to partner with Expression Manufacturing to bring end-to-end viral vector solutions to our clients,” said Mark Busch, Head of Business Development, Biopharma, Wacker Biotech US Inc. “As a leader in the production of plasmid DNA via our proprietary PLASMITEC^® platform, we now offer through this partnership the viral vector backbone technology to complete the manufacturing cycle for lentiviral delivery. Expression is a leader in viral vector manufacturing, and we look forward to working with them for our clients’ benefit to produce a diverse range of advanced therapeutics.”

This partnership positions Wacker Biotech and Expression as premium providers in the viral vector gene and cell therapy space, offering a seamless pathway from starting materials to delivered vector systems.

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-approved 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 Wacker Chemie AG.

www.wacker.com/biologics
www.wacker.com/vectorplasmids

Expression Therapeutics is a biotechnology company pioneering the next generation of gene and cell therapies targeting hemophilia, oncology, and rare diseases. Through its subsidiary, Expression Manufacturing LLC, the company operates state-of-the-art cGMP facilities designed for the scalable and efficient production of complex biologics. Its proprietary platforms enhance therapeutic safety, efficacy, and manufacturability, positioning Expression as a trusted industry partner delivering transformative medicines to patients worldwide. For more information, visit www.expressionmanufacturing.com.