Clinical Grade (GMP) Peptides

NeoMPS, Inc. has been in the GMP grade peptide manufacturing business since 1990.  Our goal is long-term customer relationships through quality and excellent customer service.

Licenses:
GMP grade peptides are manufactured in facilities licensed by the California Department of Health Services, Food and Drug Branch (Drug manufacturing license #42153 and Device manufacturing license #63358) and registered with the Food and Drug Administration (FDA registration #2028155).

FDA rapport:
The production facility at NeoMPS, Inc. has undergone six FDA audits for the years ended 1992, 1995, 1998, 2002, 2004 and 2005.  The relationship with the FDA is further established as NeoMPS, Inc. has filed Drug Master Files (DMF) for 28 products now in clinical trials.

Production capacity:
The GMP production facility has produced peptides in as little as 500 mg to as much as multi-kilogram quantities per batch.  In the fifteen years, NeoMPS, Inc. has manufactured over 325 GMP grade peptides ranging in length from 3 to 62 amino acids that are now in clinical trials.

Extensive final product testing:
  • Mass Spectral Analysis
  • Amino Acid Analysis (AAA)
  • Sequencing
  • RP-HPLC
  • Residual Organic Volatiles
  • Bacterial Endotoxin Evaluation
  • Bioburden Evaluation
  • Net Peptide Content by AAA
  • Counter Ion Content
    (Acetate, Trifluoroacetate, Hydrochloride, etc.)
  • Secondary Counter Ion Content
  • Water Content
  • Mass Balance Calculation
Additional  tests may include Specific Rotation (identity), Capillary Zone Electrophoresis (purity), Titration, etc.

Documentation:
Constant improvement of our documentation system has lead to batch records that are logical and easy to follow, not only to our personnel but to auditing clients as well.

Confidentiality:   All work performed is strictly confidential.

Contact:
Robert Hagopian, Director of Business Development
(858) 408-0820, rhagopian@mps-sd.com

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