GMP peptide manufacturing service

GMP/API Peptides - RS Synthesis

RS Synthesis provides cGMP peptide manufacturing according to FDA 21 CFR parts 210 & 211, following ICH Q7A Good Manufacturing Practices.

FDA registered, dedicated facilities for GMP peptide manufacturing, including both SOLID and SOLUTION phase synthesis, purification, lyophilization, and packaging are the foundation of the quality systems in place for the GMP peptide production services we can provide.

Class 300,000/100,000/10,000 clean rooms, and on-site water treatment facilities round out the comprehensive GMP Peptide and API manufacturing services offered.

SMALL SCALE cGMP

Mg to gram quantities, perfect for:

• Animal toxicity studies
• Small clinical trials
• Novel immunotherapy approaches
• Personalized peptide vaccination (PPV) trials
• Right to Try or Expanded Access

LARGE SCALE cGMP

5L to 350L+ Reaction Vessel Capacities available.

• Multi-gram, and multi-kg GMP peptide manufacturing expertise
• Large scale single lot capability
• Validated raw materials and equipment
• Custom and Standard CoA packages
• Specific Batch Records available (see Sample Technical Package)
• ICH storage and stability studies

Benefits Include:

• Multi-channel synthesis allowing high volume sequence trials
• Fast production and purification per individual set of sequences
• TFA, Acetate, HCL, or Ammonium salts
• High success rate
• Endo-tox and sterility testing provided
• Low cost

Typical Analyses for GMP peptides

• Appearance
• Purity by gradient HPLC
• MW by mass spec
• Peptide content
• Counter Ion content
• Water content
• Residual organic solvent content
• Endotoxin / Micro-bio

GMP Peptides

Strict quality control adherence for utmost product integrity

Full range of SOP’s meeting clinical production guidelines, SOP index

Full technical support, DMF, Module 3.

Competitive pricing as a result of scale-up expertise