Clinical Peptides & Pools

Clinical peptides and PepMix™ Peptide Pools are increasingly needed as an antigen source for clinical immune monitoring, diagnostics cell therapy and vaccine development. The diversity of applications and regulatory requirements calls for a flexible, high quality soruce for your clinical peptides. JPT is that source with its outstanding know-how on peptide antigen formats, peptide specifications and formulation, peptide manufacturability and properties as well as critical analytical release testing and batch documentation guaranteeing smooth transition from research to clinical application.

 
Building on our ISO 9001:2015 certified quality management system JPT established an enhanced peptide production environment that adds critical quality measures to the standard RuO (research use only) production, which are mandatory for clinical peptides and peptide pools. Resulting quality levels termed ISO PLUS Peptides and Clinical Grade Peptides focus on the more stringent requirements of immunotherapy, cell therapy, clinical immune monitoring, clinical proteomics as well as vaccine & drug development and have been approved for a variety of clinical applications.

Quality Control for Clinical Peptides
SPECIFICATION ISO 9001:2015
RuO
ISO 9001:2015
ISO PLUS
ISO 9001:2015
Clinical Grade
Incoming material inspection x x x
Vendor qualification x x x
Dedicated raw materials     x
Order-dedicated personnel     x
ADCF policy x x x
Certificate of analysis x x x
Document management & LIM-system x x x
Documented cleaning & calibration     x
Batch doc. & CoA (acc. IND)     x
Line clearance   x (process) x (spatial)
Optional: certified vials x x x
Shipment control x x x
Batch release     x
Optional: Additional QC methods x x x
Optional: Impurity ID & qualification Report only Report only Report only

Disclaimer: Peptides of Clinical Grade and ISO PLUS specification are designed, manufactured and tested under an ISO 9001 certified quality system. Peptides and peptide pools are intented for in vitro and research purposes only. Any use beyond this intented use requires the explicit approval of the customer’s legislative and regulatory agencies. The customer is obliged to obtain advice from local regulatory authority and shall be solely responsible to ensure that the products are suitable for customer’s particular use and that intented use will not infringe statutory law. JPT invites its customers to visit, inspect and audit its facilities to verify if peptides or peptide pools produced under Clinical Grade or ISO PLUS conditions are suited for a specific application.
Applications

Applications for Clinical Peptides & Pools

  • Clinical immune monitoring
  • Clinical proteomics
  • Adoptive cell therapy development
  • Immunotherapy development
  • Immune diagnostic development

Application Notes:

Peptide-stimulated Expansion of Virus-specific T cells for Preventative Treatment After Allogeneic Stem Cell Transplantation
Gary et al. (2015) Full Text
Developing Multi‐HIV Antigen Specific T Cells as a Component of a Cure Strategy
Lam et al. (2015) Full Text
T Cell Therapy for Viral Infections after Hematopoietic Stem Cell Transplant
Keirnan et al.

Benefits

Benefits of Clinical Peptides & Pools

  • Highest peptide purities available (up to >97%)
  • Full analytical documentation (e.g. CoA, batch documention, CMC & IND support)
  • Stringent quality control beyond ISO 9001:2015 regulations
  • Vendor qualification, ADCF policy, line clearance, batch release and more
  • Broad range of analytical options (e.g. residual solvent, stability, solubility testing, endototxin, sterility testing)
  • Applicable for individual peptides, peptide libraries and peptide pools
  • Site visits & audits welcome! 
Testimonials

Testimonials for Clinical 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 Clinical Grade 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

References

References for Clinical Peptides & Pools

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Quality Assurance

All production is performed according to ISO 9001:2015 standards.