EXPERTISE AND SERVICES
Provepep offers products, expertise and services for all stages of drug development and manufacturing using synthetic peptides or proteins.
• Peptide Design
• Chemical Synthesis : feasibility study, development and validation
• API for pre-clinical toxicity studies
• API for clinical studies
• Analytical Development and Validation
• Formulation Studies ( injectable form)
• Stress and Stability Studies
• Worldwide Quality Assurance and Regulatory Support
Provepep provides GMP production for all stages of drug development and manufacturing.
Provepep provides peptide synthesis, full analytical support (including method development and validation, reference standard, QA release and stability studies), API GMP batches for Phase I to Phase III (scaling from grams to several kg), CMC documentation, drug product formulation if required, analytical development and control, and drug stability and marketing studies.
Sterile formulation and filling for clinical trial applications is done in partnership with certified pharmaceutical laboratories.
Provepep applies a “peptide drug fast track” protocol for developing your product from the API stage to the drug product: “First-in-Man” clinical batch.