Wacker Biotech US and Expression Manufacturing Forge Strategic Alliance to Accelerate Lentiviral Vector Development for Next-Generation Gene Therapies
Wacker Biotech In an era marked by rapid advancements in gene and cell therapies, the demand for high-quality, scalable lentiviral vectors has surged dramatically. These vectors serve as vital delivery vehicles, enabling the precise insertion of therapeutic genes into patient cells—a cornerstone for the treatment of numerous genetic disorders, cancers, and other complex diseases. Recognizing this growing market need, Wacker Biotech US Inc., a wholly owned subsidiary of Wacker Chemie AG and a recognized leader in plasmid DNA (pDNA) manufacturing, has announced a strategic collaboration with Expression Manufacturing, an established innovator in viral vector technology and production.
Wacker Biotech This partnership aims to accelerate the development and manufacturing pipeline for lentiviral-based gene and cell therapies by integrating the complementary technological strengths and manufacturing capabilities of both organizations. By combining Wacker Biotech’s expertise in producing high-quality plasmid DNA with Expression Manufacturing’s cutting-edge viral vector development and production platforms, the collaboration offers biopharma and biotech companies a streamlined, end-to-end solution for viral vector development, optimization, and scalable manufacturing.
Meeting the Challenges of Lentiviral Vector Production
Lentiviral vectors are increasingly favored in gene therapy due to their ability to transduce dividing and non-dividing cells, enabling long-lasting gene expression. However, their production poses unique technical challenges—ranging from the need for high-quality plasmid DNA as starting material, to the complexity of vector design and manufacturing processes that must meet stringent regulatory standards for clinical applications.
Wacker Biotech US Inc. brings decades of industry-leading experience in plasmid DNA production, leveraging its proprietary PLASMITEC® platform. This technology uses a proprietary Escherichia coli strain optimized to efficiently produce high yields of supercoiled plasmid DNA—the molecular form preferred for gene delivery due to its enhanced stability and transfection efficiency. The platform can deliver plasmid DNA, including transfer plasmids encoding the therapeutic gene of interest as well as packaging and envelope plasmids necessary for lentiviral vector assembly, in as little as four months. This rapid turnaround is critical for accelerating research and clinical development timelines.
Operating out of Wacker’s state-of-the-art pDNA center of excellence in San Diego, California, and supported by additional manufacturing sites across Europe, Wacker Biotech is a trusted partner for clients developing various drug delivery modalities, including viral vectors. Their capabilities ensure consistent, scalable, and regulatory-compliant plasmid DNA production to meet the demands of modern gene therapy development.
Expression Manufacturing’s Expertise in Viral Vector Technology
On the other side of the partnership, Expression Manufacturing contributes its proprietary LentET™ platform—an advanced lentiviral plasmid backbone technology paired with extensive viral vector manufacturing expertise. Expression’s LentET™ technology is engineered to enhance the safety, potency, and manufacturability of lentiviral vectors, addressing critical challenges such as vector recombination risks and optimization of gene expression in production cell lines.
One of the platform’s key innovations is the use of ultra-low homology plasmid backbones. These backbones are designed to minimize sequence similarity within the viral vector components, reducing the risk of unwanted recombination events that can compromise vector safety and efficacy. Furthermore, the LentET™ system incorporates optimized coding sequences specifically tailored for 293T cells—a widely used cell line in viral vector production—to maximize viral particle yield and potency.
Expression Manufacturing’s capabilities are housed in a 43,000-square-foot viral vector production facility in West Chester, Ohio. The facility boasts multiple cleanrooms, production suites, and dedicated process development laboratories designed to support the manufacture of next-generation cell and gene therapies at clinical and commercial scale. This advanced infrastructure enables the company to provide comprehensive services spanning process development, scale-up, and GMP-compliant manufacturing.
Synergizing Strengths: A Seamless, Integrated Workflow
Bill Swaney, President of Expression Manufacturing, highlighted the significance of this collaboration: “Lentiviral vectors are transforming gene therapy by enabling delivery of complex genetic payloads with unprecedented precision. 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.”
This alliance effectively creates a vertically integrated supply chain—from plasmid DNA manufacturing to lentiviral vector assembly—reducing the complexities and risks traditionally associated with multi-vendor production processes. By synchronizing their platforms, Wacker Biotech and Expression Manufacturing enable biopharmaceutical clients to accelerate their product development cycles and reduce the time-to-market for advanced therapies.
This end-to-end collaboration has already been validated through successful client projects, demonstrating the ability to consistently produce high-quality lentiviral vectors with superior performance characteristics. By pooling their expertise and resources, the partners optimize production efficiencies and maintain the highest quality and safety standards essential for clinical and commercial gene therapy applications.
A Message from Leadership
Mark Busch, Head of Business Development, Biopharma at Wacker Biotech US Inc., expressed enthusiasm about the partnership’s potential: “We are delighted to partner with Expression Manufacturing to bring end-to-end viral vector solutions to our clients. 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.”
The partnership positions both companies at the forefront of the viral vector gene and cell therapy space, capable of delivering integrated solutions that address the complex challenges inherent in bringing novel therapeutics from the lab bench to the clinic.
Industry Context: The Growing Importance of Lentiviral Vectors
The gene and cell therapy market is experiencing exponential growth, with lentiviral vectors playing a pivotal role due to their versatility and efficiency in delivering therapeutic genes. Applications span a wide spectrum of diseases, including hematological disorders, neurodegenerative diseases, and cancers, where modifying patient cells offers potentially curative treatments.
However, the demand for lentiviral vectors is outpacing manufacturing capacities, prompting biopharma companies to seek reliable, scalable, and high-quality production partners. The collaboration between Wacker Biotech and Expression Manufacturing responds directly to this need, offering a comprehensive solution that integrates plasmid production, vector design, process development, and manufacturing under one streamlined workflow.
Advancing Innovation Through Collaboration
This strategic alliance exemplifies how partnerships between specialized technology providers can accelerate innovation in a complex industry. By combining their proprietary technologies—PLASMITEC® plasmid manufacturing and LentET™ viral vector platforms—Wacker Biotech and Expression Manufacturing create a powerful synergy that not only enhances product quality and safety but also drives faster development timelines.
Their collaboration facilitates the transfer of cutting-edge science into scalable manufacturing processes, ensuring that novel gene therapies can reach patients with greater speed and confidence. Additionally, the partnership serves as a model for future collaborations in the rapidly evolving gene therapy landscape, where integrated approaches are essential to overcoming technical and regulatory challenges.
Delivering the Next Generation of Gene Therapies
As gene and cell therapies continue to revolutionize medicine, the importance of robust, scalable, and efficient manufacturing solutions cannot be overstated. The Wacker Biotech and Expression Manufacturing partnership provides a comprehensive, end-to-end service offering that addresses the full spectrum of challenges associated with lentiviral vector production.
From the early-stage generation of high-quality plasmid DNA to the final production of potent and safe viral vectors, the collaboration ensures clients can rely on a streamlined supply chain and consistent quality standards. This not only accelerates product development but also reduces risks and complexities in the pathway toward regulatory approval and commercial launch.
Together, Wacker Biotech and Expression Manufacturing are poised to lead the next wave of innovation in gene therapy manufacturing, empowering biopharma companies to deliver transformative treatments to patients worldwide.
