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Clinical Peptides

Clinical peptides are needed for applications ranging from clinical immune monitoring and diagnostics to cell therapy and vaccine development. The diversity of applications and regulatory requirements calls for a flexible peptide supplier with sufficient know-how to vary peptide specifications, analytical procedures, and batch documentation to a significant extent.

Therefore, JPT established an enhanced peptide production environment in addition to our custom peptide synthesis and specialty synthesis units. Building on our ISO 9001:2015 certified quality management system we added critical quality measures to the standard RuO (research use only) production, that are mandatory for the clinical applications of peptides. Resulting quality levels termed ISO PLUS Peptides and GxP 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
GxP
Incoming material inspection  X X X
Vendor qualification
X X X
Dedicated raw materials
X
Order-dedicated personell
X
ADCF policy
X X X
Certificate of analysis
X X X
Document management & LIM-system
X X X
Documented cleaning & calibration
X
Batch documentation & CoA based on IND requirements
X
Line clearance
X (organizational) 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

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)
UPLC Measurement
Stability Testing
Solubility Testing
Chilled Shipping incl. Temp. Tracking


Please inquire for more information!

Disclaimer:
JPT’s peptides are for research use only and not intended for human in vivo application. JPT does not warrant that any peptides and peptide pools produced under GxP or ISO PLUS conditions are applicable in clinical applications (clinical grade peptides). JPT invites its customers to visit, inspect and audit our facilities to make an educated decision on whether or not peptides or peptide pools produced under GxP or ISO PLUS conditions are suited for a specific application.

Applications for Clinical Peptides

  • 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
by R. Gary, M. Aigner,  A. Gerbitz, University Hospital Erlangen, Erlangen, Germany
and A. Moosmann, Helmholz Zentrum München, Munich, Germany.
Developing Multi‐HIV Antigen Specific T Cells as a Component of a Cure Strategy
by S. Lam, C.R. Cruz and C. Bollard, Children’s National Medical Center, Washington, USA
T Cell Therapy for Viral Infections after Hematopoietic Stem Cell Transplant
by J. M. Keirnan, C. M. Rooney, and A. M. Leen , Baylor College of Medicine, Houston, USA

Benefits of Clinical Peptides

  • 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 for Clinical Peptides

"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

More testimonials

General applications for peptides in immunotherapy and vaccine development:

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for Clinical Peptides

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Quality Assurance

All production is performed according to ISO 9001:2015 standards

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