The UW Advantage

Mission | Vision | Values

Our mission is to accelerate the advancement of novel biological therapies and vaccines into early-stage clinical trials by staying at the forefront of innovative biotechnology.

We strive to deliver an efficient, flexible, and collaborative partnership while maintaining a high level of quality and industry-standard services. 

Our Story

Waisman Biomanufacturing was founded in 2000 as one of, if not the first, multi-product biotechnology manufacturing facilities to bridge the gap between discovery and therapy. From our inception, we sought partnerships with academic investigators and biotechnology companies across the globe delivering several novel classes of biologics into human clinical trials.

• Plasmid DNA - we pioneered the industry in GMP plasmid, at clinical phase appropriate scale, for several infectious disease vaccine indications and other manufacturing uses.
• Pluripotent Stem Cells - we were the first CGMP facility to bank embryonic stem cells under CGMPs, reprogram induced pluripotent stem cells (iPSC) as CGMP Master Cell Banks, and delivered the first allogeneic iPSC-derived cell therapy into human clinical trials.
• GMP cytokine reagents - we launched GMP grade FGF-2 and supplied the industry with this critical cytokine for stem cell culture media for many years, leading to a boom in quality related to cellular therapy manufacturing.

We have partnered to deliver over 70 US FDA INDs, and many more international regulatory applications, in our history and look forward to partnering with you and continuing to drive the biotech industry into the future.

Our Industry-Academia Hybrid Operational Model

As our client, you will gain a highly flexible and collaborative contract development and manufacturing partnership. You will have access to a dedicated project manager, scientific manufacturing and quality team leads, and an industry-experienced leadership team.

• Collaborative Mindset - At Waisman Biomanufacturing, we pride ourselves on scalable and transferable solutions that expedite your path to clinical trials, saving you both time and costs. Our collaborative approach is at the core of what we do, forming seamless partnerships that drive success—think of us as two strands of a double helix, working together towards a common goal. With the capacity to handle up to 20 active clients, we’re ready to accelerate your project, whether it’s a quick aseptic fill or a more complex full development program. Let's bring your innovations to life.
• Project Management - You will have a dedicated project manager for day-to-day communication, as well as access to department team leads and leadership. We approach each project with the flexibility and adaptability required to translate novel vaccines and biotherapeutics into the clinic.
• Equipment and Facilities - We maintain broad equipment capabilities, prioritizing single-use technologies, and ensuring options are available for future scalability. As a multi-product facility, we ensure equipment is cleaned and maintained to the most appropriate CGMP standards.
• Quality Systems - Our GMP quality management system undergoes rigorous internal and external audit and our electronic facility master file is maintained and ready to support your Investigational New Drug (IND) filing with CBER/CDER.
• Staffing - Waisman Biomanufacturing is dedicated to providing timely, cost-effective solutions, supported by our team's unparalleled technical expertise and specialized training. Our extensive experience with a variety of bacterial cells, mammalian cells, disease indications, and diverse product types ensures new clients their projects are expertly managed. With a proven track record, we offer unmatched confidence and reliability in every partnership.
• Flexibility - We offer phase-appropriate solutions, ensuring that your Phase I and II needs are met with the right depth and precision. Our flexibility allows us to tailor our processes to align perfectly with your goals, all while adhering to the highest GMP industry standards. We’re committed to providing customized support that drives your success at every stage.