Cell and Gene Therapy Product Development Timeline
Partnering with AllCells for RUO and GMP-compliant products to span the entire workflow mitigates timeline and cost delays that could arise from having to re-validate source material and suppliers. This also provides the flexibility and agility to bilaterally transition between pre-clinical and clinical phases to address the dynamic nature of cell therapy product development.
What is the difference between RUO and GMP?
AllCells maintains the same high quality material and optimized protocols for both RUO and GMP Products. Since GMP products are intended for further commercial manufacturing for clinical use, it must meet rigorous mandated standards to ensure quality, safety and efficacy of the end therapeutic product. Our GMP products additionally meet the requirements for extensive quality review and documentation necessary to meet the FDA Regulations of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s) as well as the EMA’S human cell-based medicinal products guidelines. This additional level of quality-assured specifications is applied at the multiple levels:
|Parameter||Clinical Grade (GMP)||Research Grade (RUO)|
|Donor Testing||CMV-negative donors are subject to viral testing (above the standard infectious disease panel) per FDA-mandated 21 CFR 1271 as well as CDC, NIH, and AABB recommendations||Eligible donors are screened against an infectious disease testing panel: Hepatitis B, Hepatitis C, and HIV.|
|SOP||GMP operational SOPs with extensive GMP documentation.||Validated SOPs per QMS standards.|
|Quality Testing||Validated AO/PI protocol for cell count and viability. Sterility testing per USP71 guidelines.||Validated AO/PI protocol for cell count and viability.|
|Documentation provided||Certificate of Analysis. GMP documentation including batch records, equipment validation, stability studies, to support product for further manipulation.||Certificate of Analysis provided.|
|Manufacturing facility (equipment, infrastructure, processes)||GMP-Qualified Cleanroom space. Rigorous operational controls and standardized, comprehensive operational SOPs.||GMP-like collection and processing facilities Research use only.|
|Shipping||AeroSafe Global Shipping – Packaging validated to ISTA standards, Temp. Logger standard.||Aerosafe Shipping.|
Donor Management Services
Donors with the right attributes are a critical part of any cell therapy program. AllCells Donor Management Services can help you find, screen and retain donors from our repository comprised of highly-characterized, HLA-typed donors with diverse demographics and clinical parameters that can meet program-specific criteria from research and development to commercialization.
Project Management Services
AllCells strives to establish long-term working partnerships with researchers, contract-research organizations (CROs), and contract-development or manufacturing organizations (CDMOs), to deliver GMP-compliant clinical grade products.
To help clients navigate the complexities of cell therapy programs, AllCells has a dedicated clinical-grade team, which includes key personnel such as the project manager, donor management and regulatory personnel to ensure the success of each project.
This experienced and multi-disciplinary team manages recruits and establishes client-specific donor pools, as well as provides long-term and complex project management to oversee multiple staggered timelines for longitudinal studies. The clinical-grade team works with clients in real-time to review donor screening results, establish donor pool needs (exclusion/inclusion criteria) and facilitate trouble-shooting as required.
- Dedicated Clinical Grade team(product manager, donor management personnel, regulatory) to ensure success of the project.
- Complex projects that involve multiple staggered timelines for longitudinal studies, dedicated prescreened donor pool set up, recruitment and management etc.
- Work with the clients in real time to review results, to devise strategy for achieving desired donor pool needs/criteria (exclusion/inclusion criteria) and end-product (troubleshooting).
Product Customization Services
The unique needs of cell and gene therapy programs often necessitates products that require customization. AllCells has proven experience with clients in successful technology and process transfers for custom isolations and other specific requirements. We are happy to work with external vendors on our client’s behalf for any additional services or characterization testing (i.e., biostorage capabilities, karyotype analysis) that is not currently offered by AllCells.
- Technology and process transfers for custom product or isolations
- Flexibility to work with external vendors per the needs of customers (testing partners, biostoring partners etc)
A leukopak is an enriched leukapheresis product collected from normal peripheral blood, which contains a concentrated fraction of mononuclear cells like lymphocytes and monocytes. Ideal for regenerative medicine and cell therapy applications requiring isolated hematopoietic stem cells (HSCs) and immune cells (i.e., T cells, NK cells).
GMP BONE MARROW
Bone marrow is enriched in hematopoietic stem cells (HSC) and mesenchymal stem cells (MSC) capable of multi-lineage differentiation into a number of clinically relevant cell types to facilitate the treatment of a wide scope of human diseases.
COMING SOON GMP CRYOPRESERVED LEUKOPAKS AND CRYOPRESERVED PBMCs
Contact us via the form below for more information.
ACCREDITED AND RELIABLE
AllCells boasts unparalleled scientific expertise, managing all necessary screenings and testing
for donor eligibility, extensive apheresis and marrow collection expertise,
coupled with a logistics and quality team expertise necessary to ensure high
quality, consistent starting material, that is delivered globally.
- FDA establishment of HCT/P for HPC Apheresis, PBMCs
- 45 CFR 46 – Protection of Human Subjects
- 21 CFR 56 – IRB oversight of institution
- 21 CFR 50 – Informed Consent / Human Subjects
- 21 CFR 1271 Subpart A-C and Provisions of Subpart D (GTPs)
- European Directive 2004/23/EC; European Directive 2006/17/EC
- Federal CLIA Certificate of Compliance
Need More Information?
We realize the importance of finding the right partner for your research and want to make it as easy as possible for you to find the answers to all of your questions. Feel free to contact our Customer Support Team via our easy email form below.