human cells

The future of life-changing cellular therapy begins with Dendreon

Scientist taking a sample out of a petri dish using a pipette

Dendreon Is the Pioneer of Innovative Cellular Therapy

Experience in developing, manufacturing and commercializing cellular therapies makes all of the difference to ensure product quality. We were the first company to successfully develop and commercialize an immunotherapy made from a patient’s own cells and worked tirelessly with the FDA to define the rules, guidance, and regulations that govern immunotherapy commercialization. This work has helped seed other cellular therapy companies, treatments, and technologies you see today.

Putting test tubes into the holder

We Help Partners Drive Novel Therapies to Market

We have the expertise to successfully support our partner’s go-to-market strategies with proven processes that mitigate hurdles along the way. Utilizing leading-edge technologies and extensive expertise, we help partners drive innovative therapies through preclinical to commercialization. Our team of experts has decades of development and commercialization experience, allowing us to tailor our services in process and analytical development, manufacturing, clinical and regulatory support to meet your therapy’s unique needs.

Dendreon headquarters

Take A Tour of Our Facilities

Dendreon’s facilities are designed and validated for both clinical and commercial manufacturing, enabling a flawless transition from research and development to commercial manufacturing. Our proven world-class cGMP manufacturing specializes in autologous and allogeneic cell therapies.

Our footprint spans across three geographic hubs in the U.S. With our longstanding clinical and regulatory infrastructure, we are able to support all stages of clinical development and commercialization, allowing for a seamless transition from the clinical phase to commercial production.

Our two cGMP facilities are located on the west and east coasts with commercial-scale manufacturing capabilities and proprietary logistics for time-critical delivery of cellular therapies. Our Research and Manufacturing Sciences Facility is based in Seattle and has laboratories to support preclinical and early clinical manufacturing. It is staffed with analytical and process development teams and is also home to our Patient Operations, Clinical and Medical Affairs, Regulatory Affairs and Pharmacovigilance.

Process & Analytical Development

Groundbreaking

Dendreon developed the first approved immunotherapeutic potency assay in 2006. Like many novel cellular therapies, it was difficult to identify the needed potency assay to correlate with efficacious and desired outcomes of treatment. We have proven expertise collaborating with the FDA in developing and identifying the proper potency assay for commercial approval of cell therapy.

State Of The Art

Our facilities are equipped with state-of-the art systems, equipment, and processes imperative to cellular therapy manufacturing. Our experts helped develop instrumentation that allowed for increased efficiency in cell therapy processing, resulting in many of the cutting-edge machines used today, such as the Lovo. Since then, we’ve continued to improve our technologies, allowing for better manual, semi-automated, and automated processing. Today, our facilities are equipped with the premier cell processors of our time: the Prodigy, Xuri, Lovo, and G-Rex® technologies.

Expert Systems

Cellular therapy manufacturing is where antibody manufacturing was 10 years ago. The industry is utilizing systems, equipment, and processes that have been tweaked for cell therapy but are not yet ideal. As the technology of semi-automated and automated processes evolve over the next decade, Dendreon has the significant experience and expertise needed to establish modern processes and analytical methods, putting Dendreon at the vanguard of cell therapy manufacturing.  

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Quality You Can Trust

At Dendreon, we believe quality is obtained through a culture ingrained in trust, integrity, and transparency. Our commitment to high-quality culture is exemplified through our people, systems, customers, and our patients. Dendreon’s quality philosophy is based on balancing business needs and compliance. We do this by ensuring a phase-appropriate Quality approach while working in a collaborative manner with our clients.

Our Quality Assurance (QA) team ensures consistent oversight in all aspects of cGMP production including facility, manufacturing operations, and Quality Control (QC). This team supports the manufacturing operations by providing technical expertise and execution of in-process, release, and stability testing requirements that ensure data integrity throughout all phases of development and commercialization.

Scientists wearing full protective suit working in the laboratory

Our QC Capabilities

Dendreon’s QC department provides a wide array of services to support your cellular therapy product for in-process, release, and stability testing. We have a range of equipment to support both compendial and product-specific tests.  Equipment available in our QC laboratories includes, but is not limited to: flow cytometry, PCR,  BacT Alert, endotoxin, and cell-based potency assays. In addition to our in-house services, we also offer oversight and support for extended characterization, utilizing our qualified outsourced partners.

Dendreon’s Unmatched National Patient Logistics Network

Our Patient Operations team manages the creation of production plans and executes arm-to-arm activities for cellular treatments through our proprietary system and infrastructure. These activities include – but are not limited to – site onboarding, enrollment intake, benefits verification, apheresis management, demand planning, logistics analysis, scheduling, order management, account management, and real-time product monitoring.

Our experts

Our trained experts manage an unmatched logistics network capable of delivering time-critical therapies within an 18-hour window to anywhere in the U.S.

Reliable & cost-effective

We conduct continuous logistics analysis to find reliable, cost-effective routes that both mitigate risk and deliver therapies within the preferred time window.

Our proprietary system

Our proprietary system executes 70 calculations with 20 different access queries to determine the logistics necessary for optimal production and delivery for every patient

Patient focus

We move mountains to deliver life-changing therapies to our patients: One million Dendreon drive/flight routes can be generated within an hour.

We promise to fight for illness prevention

Enable the future of your therapy and reach the patients who need you.