GxP Peptides & Peptide Pools: Clinical Grade Peptides
Clinical Grade peptides like GMP peptides are needed for applications such as cell therapy and vaccine development. Therefore, we established an enhanced peptide production environment for GxP peptides in addition to our ISO 9001:2015 regulated custom peptide synthesis and specialty synthesis units. The new production environment for individual peptides and peptide pools goes beyond ISO 9001:2015 regulations for the more stringent product requirements of immunotherapy as well as vaccine & drug development, based on our knowledge and experience from research collaborations and quality audits by external laboratories and certification bodies. Thus, the resulting GxP peptides and GxP peptide pools have been approved for specific clinical applications.
Quality Control for GxP Peptides & Pools
JPT pre-qualifies all suppliers for adherence to and delivery of reagents with established and appropriate specifications.
Incoming Material Inspection
JPT performs identity testing of critical reagents used in production.
Throughout the production and purification for GxP peptides, JPT assures that contamination by peptides not belonging to the specific GxP peptide pool is excluded.
JPT utilizes disposable materials and devices when appropriate. For each project, JPT will segregate equipment and devices that undergo a validated cleaning prior to use.
Customers will receive status reports throughout the entire GxP peptide production process and will be informed of any changes in the production process after completion of production.
QC /QA Documentation
Customers will receive an analytical data sheet for each peptide and the resulting peptide pool(s). All analytical raw data will be provided. Synthesis and purification processes are traceable and supported by an electronic LIMS software. All production documentation will be archived at JPT and made available for audit and inspection.
Batch release is performed by review and inspection of all analytical data, deviations and documentation by a dedicated and qualified person.
Optional Analyses for GxP Peptides & Pools
|Chemical Analyses||Microbiological Analyses|
|Residual Solvent Determination (ICH Guideline Q7A)||Bacterial Endotoxin Determination (Ph.Eur. 2.6.14)|
|Water Determination (ICH Guideline Q7A)||Sterility Testing (DIN EN ISO 11737-2 and Ph.Eur. 2.6.1)|
|Counter Ion Determination,TFA, HCl, Acetate (ICH Guideline Q7A)||Bioburden Determination (DIN EN ISO 11737-1)|
|Peptide Content Determination (ICH Guideline Q7A)||Bacteriostatic and Fungistatic Effect (B&F test) of Products (Ph.Eur. 2.6.1)|
|Amino Acid Analysis (ICH Guideline Q7A)|
|Chilled Shipping incl. Temp. Tracking|
Please inquire for more information!
JPT GxP peptides are not intended for human in vivo application. JPT does not warrant that any peptides and peptide pools produced under GxP conditions are applicable in clinical applications (clinical grade peptides). JPT invites its customers to visit, inspect and audit its facilities to make an educated decision on whether or not peptides or peptide pools produced under GxP conditions are suited for a specific application.
Applications for GxP Peptides & Pools
- In vitro stimulation of antigen specific CD4 and CD8 T cells
- Generation of antigen specific CD4 and CD8 effector/memory T cells
- Research on dendritic cell vaccination strategies and antigen delivery
- Immunotherapeutic applications
- Clinical immune monitoring
"Peptide-stimulated expansion of virus-specific T cells for preventative treatment after allogeneic stem cell transplantation"
by R. Gary, M. Aigner, A. Gerbitz, University Hospital Erlangen, Erlangen, Germany
and A. Moosmann, Helmholz Zentrum München, Munich, Germany.
Benefits of GxP Peptides & Pools
- Highest peptide purities available (up to >97%)
- Full analytical documentation
- Stringent quality control beyond ISO 9001:2015 regulations (clinical grade peptides)
- Vendor qualification, ADCF policy, line clearance, batch release and more
- Regular status reports and comprehensive QC /QA documentation
- Additional analyses optional (e.g. residual solvent, stability, solubility testing, endototxin testing)
- Applicable for individual peptides, peptide libraries and peptide pools
Testimonials for GxP Peptides & Pools
"My group is developing therapeutic strategies for using in vitro expanded virus-specific T cells (VSTs) for the treatment of viral infections in immunocompromised patients. We recently demonstrated the feasibility and clinical benefit associated with the infusion of rapidly generated single-culture VSTs, manufactured using JPT's GxP PepMix™ peptide pools covering 12 immunogenic antigens from five viruses (EBV, AdV, CMV, BK, and HHV6). When administered to 11 allogeneic stem cell transplant recipients, 8 of whom had up to four active infections, these VSTs produced an overall 94% response rate."
Ann Leen, PhD, Baylor College of Medicine, Houston, TX, USA
"We utilize customized 15-mer PepMix™ peptide pools encoding for weak tumor associated antigens for immunomonitoring of cancer patients treated with recombinant therapeutic vaccines. Our experience with JPT has been outstanding in regard to product quality and communication with scientific and administrative customer service. JPT is the only company we trust to synthesize the 15-mer peptides and corresponding pools for our clinical trial evaluations."
Benedetto Farsaci, MD, National Cancer Institute, NIH, Bethesda, MD, USA
"Our work focuses on TGF-beta in physiology and cancer as well as the differentiation and expansion of human T cells in vitro for adoptive immunotherapy. For our early phase clinical trials we are in need of T cell EBV specific stimulants having an exceptional quality. JPT's customized PepMix™Peptide Pools not only proved to deliver excellent performance in our in vitro culture systems but accompanying QC/QA documentation was essential to prepare our application to our regulatory agency.”
Dr. Jean-Sébastien Delisle, Université de Montréal, Centre de recherche de l'Hôpital Maisonneuve-Rosemont, Canada
Selected References for GxP Peptides & Pools
"Peptide‐stimulated Expansion of Virus‐specific T cells for Preventative Treatment After Allogeneic Stem Cell Transplantation"
Gary et al., Application Note (2015)
"Complete Remission Following Decitabine/Dendritic Cell Vaccine for Relapsed Neuroblastoma"
Krishnadas et al., Pediatrics. (2013) - PMID: 23266925
"Expanded Cytotoxic T-cell Lymphocytes Target the Latent HIV Reservoir"
Sung et al., Journal of Infectious Diseases (2015) - PMID: 25589335
"Broadly-specific Cytotoxic T Cells Targeting Multiple HIV Antigens Are Expanded From HIV+ Patients: Implications for Immunotherapy"
Lam et al., Molecular Therapy (2015) - PMID: 25366030
"Ex vivo Expansion of Human T cells for Adoptive Immunotherapy Using the Novel Xeno-free CTS Immune Cell Serum Replacement"
Smith et al., Clinical & Translational Immunology (2015) - PMID: 25671129
"QIMR Berghofer Medical Research Institute Selects JPT’s GxP PepMix™ Peptide Pool Technology to Support its Phase I/II Clinical Trials of Adoptive Immunotherapy for Human Cytomegalovirus-associated Diseases"
Press Release (2014)
Read More References with GxP Peptides & Pools
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Read a new Application Note on GxP Peptides for Cell Therapy
QIMR Berghofer Medical Research Institute Selects JPT’s GxP PepMix™ Peptide Pool Technology to Support its Phase I/II Clinical Trials of Adoptive Immunotherapy for Human Cytomegalovirus-associated Diseases
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