The future of life-changing cellular therapy begins with Dendreon
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.
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.
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
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.
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.
