cGMP Quality Management

ZPC manufactures cGMP grade peptides for clinical trials and Generic peptide APIs under strict adherence to FDA 21 CFR parts 210 & 211 and ICH guideline Q7 for Active Pharmaceutical Ingredients;

CFR 210/211, ICH Q7A;

cGMP program is designed to strictly adhere to FDA cGMP guidelines;

ZPC can handle projects from 1mg to 10Kg/lot;

Reactor 1~200 liter, Lyo 5 m2, column up to 12”;

Raw materials BSE free;

No cross contamination: One peptide, one column or one batch of media;

Process/Analytical method transfer/validation. 

cGMP Peptide Manufacturing Services

Process validation

Analytical Support

Stability studies

Chemistry, Manufacturing and Control (CMC)

New Chemical Entities (NCEs)

Active Pharmaceutical Ingredients (APIs)

Generic Peptides

Regulatory Support

Innovative Technology Ensure High Quality

Solid Phase Peptide Synthesis -SPPS Solution Phase Peptide Synthesis (Liquid Phase Peptide Synthesis)-LPPS Hybrid Synthesis Technology Ligation Strategies

Quantity: Lab scale to Multi- Kg production with purity up to >99%

Sequence Length: More than 100 amino acids in length

Modifications: Simple modifications to highly complex chemistries

Conjugation: Proven track record in peptide conjugations

Chemistry: Extensive experience in Fmoc,Boc and Cbz strategies

Purification: Large scale peptide purification systems

Drying and product finishing: Largescale tray lyophilizer