PeptiFactory offers comprehensive, flexible GMP services that fully comply with international regulatory standards, covering the entire product lifecycle—from early-stage development through to commercial-scale manufacturing.
By combining advanced manufacturing platforms, rigorous quality systems, and extensive project experience, we deliver high-quality, diverse, and customized solutions to clients worldwide.
Integrated GMP Manufacturing Solutions
Our integrated GMP manufacturing capabilities support the development and production of a wide range of complex molecules, including peptides, small molecules, and bioactive compounds. Through seamless technology transfer and scale-up capabilities, we ensure an efficient transition from laboratory-scale research to commercial-scale production.
Core Capabilities Include:
- Research to Commercial GMP Manufacturing
- Process Development & Optimization
- Scale-up & Technology Transfer
- API & Intermediate Manufacturing
- Flexible Manufacturing Models
Service Highlights:
- Solid-Phase Peptide Synthesis (SPPS) & Liquid-Phase Peptide Synthesis (LPPS)
- Long-Chain & Complex Peptides (e.g., Peptide Conjugates, Cyclic Peptides, etc.)
- High-Purity Separation & Purification (Prep HPLC, Chromatography)
- Lyophilization & Final API Production
- Analytical Method Development & Validation (ICH Guidelines)
Custom Peptide Synthesis (GMP)
PeptiFactory possesses industry-leading technology platforms and scalable capabilities in the field of GMP peptide synthesis, supporting production requirements ranging from milligram to multi-kilogram (hundreds of kilograms) scales.
Custom Organic Synthesis (GMP)
We provide high-quality custom synthesis services for small molecules, particularly suited for complex structures and challenging synthetic routes.
Service Scope:
- Route Design & Process Development
- Synthesis of Advanced Intermediates & APIs
- Chiral Synthesis & Asymmetric Catalysis
- Impurity Profiling & Control Strategies
- Process Validation & Commercial Manufacturing
Key Strengths:
- Robust Process Chemistry Team
- Efficient Resolution of Critical Scale-up Challenges
- Compliance with Global Regulatory Requirements.
Capabilities Include:
- Design & Production of High-Activity, Multifunctional Peptides
- Pharmacologically Active Peptides (e.g., hormones, signaling peptides, etc.)
- Peptide Modifications (PEGylation, lipidation, etc.)
- Customized Purity & Quality Specifications
Quality Assurance:
- Strict Control of Impurity Profiles
- Stability Studies & Data Support
- Comprehensive Analytical & Characterization Systems
Biologically Active Peptides
PeptiFactory specializes in the development and GMP manufacturing of biologically active peptides, catering to the diverse needs of the biotechnology, and research sectors.
Why Choose PeptiFactory for GMP Services
- Deep expertise focused on peptides and complex molecules
- End-to-end services: from development through commercialization
- Flexible, customized solutions responsive to client needs
- Globally compliant quality systems & extensive audit experience
- High success rate in technology transfer & scale-up