How do I build an allogeneic cell bank that meets the needs of my target population? What’s the best way to design, optimize and execute the clinical trial for an allogeneic or autologous cell therapy? How do we develop an allogeneic or autologous cell therapy that meets regulatory requirements in different countries?
Questions like these are common as cell and gene therapy sponsors plan for clinical trials. We have unique experience and knowledge of managing the cell therapy supply chain and the clinical aspects of cell therapies developed over our long history. Importantly, we have physicians on staff with the cell therapy expertise you need.
We’re bringing that knowledge to companies like yours through consulting services in the areas of:
- Immunogenetics and bioinformatics
- Clinical research including biorepository capabilities, pre-clinical and clinical trial design and support, and data analysis
- Quality and regulatory compliance
- Physicians with direct experience in designing and executing clinical trials in the field of cell therapy
We offer a deep knowledge of HLA that can’t be matched
Our immunogenetics and bioinformatics team has the data and analytical expertise to help define your HLA targets and build your allogeneic cell bank.
Examples of our areas of consultation are:
- HLA population modeling
- Optimization of your “off-the-shelf” cell bank
- HLA characteristics that could impact your therapy
- Identification of genetically compatible cell sources for therapy development
Through the CIBMTR Bioinformatics Research Program, our researchers and scientists are continually advancing the field of immunogenetics and transplant/cellular therapy genomics.
This allows us to apply the latest scientific breakthroughs to strengthen our clients’ cell therapy programs with advanced translational and operational bioinformatics support.
of HLA expertise in cell therapy
HLA-typed potential donors on the Be The Match Registry®
Source: DnA – BDA QUER-806
How can we support your cell therapy development?
Let’s discuss how our immunogenetics and bioinformatics professionals can help you advance the development of your cell or gene therapy.
We’ve conducted cell therapy research for decades
We conduct research and help cell and gene therapy sponsors design and execute protocols through the CIBMTR.
For investigators conducting prospective and retrospective clinical studies for autologous or allogeneic cellular therapies, the CIBMTR offers services such as:
- Trial design and management
- Statistical support
- Sample management
- Publication support
The CIBMTR has infrastructure in place for multicenter prospective Phase I-III trials and observational studies requiring statistical and/or logistical support.
For cell and gene therapy sponsors who have commercial therapies, the CIBMTR collects long-term outcomes data that can be used to meet regulatory follow-up requirements.
CIBMTR Research Activity
centers participating in research
ongoing studies and clinical trials
patients in database
Sources: Center for International Blood and Marrow Transplant Research 2020 Annual Report; CIBMTR.org 2020
What questions do you have?
Our team is ready to discuss how we can help you design your clinical studies.
Our team understands global regulatory compliance is critical
Our regulatory specialists work with clients to help them overcome domestic and/or international regulatory challenges. They advise clients on developing de novo collection protocols that meet both FDA and international regulatory requirements. The team is well-versed in the U.S. regulatory requirements for cellular therapy starting material, including 21 CFR Part 1271 GTP and 21 CFR Part 211 GMP. The team is also familiar with international starting material requirements such as: European Union Directives 2004/23/EC, 2006/17/EC, 2002/98/EC and 2004/33/EC; Australia’s Therapeutic Goods Order No.108 and 109; Canadian standards CAN/CSA-Z900.1.22 and CAN/CSA-Z900.2.5.22; and Japan’s MHLW Notification No. 375 and No. 0907-3.
Examples of international regulations that our team has helped clients successfully integrate into their protocols include:
- European Directives 2002/98/EC and 2004/23/EC (European Union)
- CAN/CSA-Z900.1-17 (Canada)
- Therapeutic Goods Order No. 88 (Australia)
Our quality and regulatory specialists support the advancement of cell therapies by:
- Understanding unique product requirements and supply chain
- Identifying applicable U.S. and/or global regulatory requirements
- Consulting with clients to develop cell collection specifications that meet regulatory requirements
Access additional services
Supply Chain Management
Oversight and coordination of your autologous cell therapy supply chain from end to end.
Allogeneic Cell Sourcing
Identification and souring of high-quality donors matching your specific therapy needs.