Seattle Children’s Therapeutics
Join Us In Taking Cell, Gene and Protein Therapies From Bench to Bedside Faster
All too frequently, patients receive diagnoses for diseases with no treatment. Seattle Children’s Therapeutics aims to change this reality. As a novel nonprofit therapeutics-development enterprise, we take breakthrough basic science discoveries from the lab and turn them into clinical therapies that can be safely administered and evaluated in patients with the greatest need.
By creating and testing next-generation biologic (e.g., cell, gene and protein) therapies, we bring patients the hope, care and cures they need and deserve.
Clinical-Grade Infrastructure & Services
We have developed our infrastructure to seamlessly bring therapies into early-stage clinical trials and provide comparable services as a commercial contract development and manufacturing organization (CDMO), with the required phase-appropriate level of safety and regulatory rigor.
Our experienced team helps investigators and industry partners in every step of the drug development process:
- Concept Ideation: Initial strategy and therapeutic design
- Preclinical and Process Development: Bridging the gap between research and production
- Regulatory Interactions: Navigating the complexities of regulatory compliance
- Manufacturing: GMP-compliant production of advanced biologic products
- Early-stage clinical development: Implementation and completion of early-phase clinical trials
Solving Complex Challenges in Rare Diseases
We are dedicated to finding cures for patients and families affected by complex and rare diseases. The therapies designed and manufactured by the Seattle Children’s Therapeutics’ team include autologous CAR-T cells, stem cells and more. Our cell-based products can be used for variety of clinical indications, from cancer to autoimmune disease, allowing us the opportunity to save lives around the world.
A History of Success
A Strategic Ecosystem for Therapeutic Innovation
At Seattle Children’s Therapeutics, our comprehensive resources and advanced facilities allow us to expand our impact on cell, gene and protein therapies for a variety of diseases and clinical conditions.
In addition, our integrated structure sets the stage for accelerated progress in drug development. Our infrastructure comprises:
- Business operations
- Clinical trials development and management
- Data management and statistical analysis
- GMP facilities for cell manufacturing
- Regulatory interactions
- Research and development
- Technology development
Therapeutics Cell Production Core
While our foundation is built on pioneering CAR-T innovations, our facility is engineered for therapeutic versatility. Our 11,000-square-foot GMP-compliant, FACT-accredited manufacturing facility includes 12 clean room production suites and dedicated laboratory space for quality control testing and process development. Our expert team provides a full range of services from preclinical assistance to finished product dlivery.
Procedural and Regulatory Services
- Adaptation of research laboratory methods to a GMP manufacturing environment
- Assistance with developing budgets for grant proposals
- Support for defining a regulatory pathway aupported by interactions and submissions
- Development of SOPs, timelines, and regulatory & clinical milestones
- GMP-compliant record keeping and reporting.
Manufacturing Services
- Analytical assay and manufacturing process development
- Product scale-up and clinical grade reagent/materials sourcing
- Full-service manufacturing by highly trained manufacturing staff
- Long-term manufacturing archiving
- Quality control/in-house and outsourced testing of manufactured products
- Quality assurance oversight to ensure clinical product safety and regulatory compliance
Partner With Us
Our mission-driven culture, scientific excellence and trusted reputation make Seattle Children’s Therapeutics an ideal partner of choice for researchers, other non-profit institutions and industry.
We have extensive experience and existing partnerships with industry partners that license our IP, sponsor preclinical research, and who leverage our regulatory and clinical expertise to conduct early-phase clinical trials.
In the News
- March 14, 2024 Could cancer-fighting therapy be used to treat young lupus patients? Seattle Children's study seeks answers (KUOW)
- December 10, 2023 Colleen E. Annesley, MD, on Working to Mitigate Inferior Cell Persistence With Manufactured T-APCs (CGTlive)
- December 5, 2023 ‘Kid-first’ startup BrainChild Bio wants to shift the paradigm on pediatric cancer drugs (Fierce Biotech)
Contact Us
Make a Gift
If you are interested in learning more about how your donation can support our critical work, please contact Brei Haywood, program manager at Seattle Children’s Foundation, by email.