cGMP Peptide Service

cGMP Peptide Service

Creative Peptides specializes in the commercial production of peptides active pharmaceutical ingredients (APIs), cosmetic peptidesand functional peptides, as well as the development of custom peptide manufacturing processes. We are dedicated to providing proprietary and generic cGMP-grade peptides to pharmaceutical companies and the biotechnology market.

Current Good Manufacturing Practices (cGMPs)

cGMP is the regulation provided by the FDA that guides the design, monitoring, and maintenance of manufacturing facilities and processes. Creative Peptides adheres to cGMP guidelines and has FDA-inspected manufacturing facilities to ensure superior quality of the peptides produced. Our team of peptide experts has the experience and expertise to implement cGMP services throughout the entire project process to help accelerate your peptide drug development process for eventual commercialization.

cGMP Services

Peptide APIs Manufacturing: high active API capacity from grams to multi-kilograms

Peptide Protection: Boc-, Fmoc-, Cbz- protect groups

Peptide Modification: chemical modification of peptide and peptidomimetics, backbone modification of peptide, side chain modification of peptide

Peptide Synthesis

Peptide Analysis Service

With the continuous progress of peptide development technology, such as chemical synthesis, fermentation, phage display, and computer-aided drug design (CADD), the structure of peptide molecules has changed (e.g. the average length of peptide sequences is gradually increasing), and the combination forms of peptide molecules are also more diversified. Initially, peptide drugs consisted of natural amino acids, and then D-amino acids or other unnatural amino acids were introduced, and gradually expanded to fatty acid modification, PEGylation, as well as coupling with proteins, small molecules, or other functional groups.

Creative Peptides has established a strict quality management system, using the latest GMP compliant technologies and systems, cGMP compliant facilities and a highly qualified quality management team. We are committed to providing high quality peptide products and services to our customers. At present, we have successfully completed several cGMP peptide APIs production projects.

Quality System

Auditing electronic batch records for cGMP status

Corrective & preventive action tracking (CAPA)

Document management and document control

Deviation investigation

Analytical testing and release of the product

Ensuring the safety, integrity, strength, purity, and quality (SISPQ) of the product

Complaint management

Capacity

Focused on developing peptide production processes from small to large scale, from gram to kilogram scale.

Large scale of solid phase peptide synthesis (SPPS), liquid phase peptide synthesis (LPPS)and hybrid fragment synthesis, as well as Fmoc and t-Boc based solid phase manufacturing available.

Process development and scale-up capabilities ensure stable commercial production processes.

Complex sequences and peptide modifications suitable for large scale production.

Comprehensive analytical platform using innovative purification and separation technologies.

Quality system audited by key regulatory agencies and partners.

Analysis

Molecular weight

Solubility

Peptide content

Salt content

Water content

Lonic identification

Microbial limits

Endotoxin

IR spectrum

Specific rotation

Compliance

Registration of APIs

CMC information required for an IND

IND and NDA support

Drug master files (DMF) filing

Why Choose Creative Peptides?

Creative Peptides' cGMP manufacturing site is designed in strict compliance with FDA guidelines, enabling large-scale cGMP production of peptides. As a leading global peptide manufacturer, our team has the experience and expertise to enable drug discovery and development support.

FAQs

cGMP ensures that peptides are produced in compliance with strict quality control measures, maintaining the highest standards for purity and consistency, which is critical for research and industrial applications.

We implement a rigorous quality management system that includes electronic batch record auditing, analytical testing, and corrective actions to guarantee the safety, strength, and purity of each peptide batch.

Yes, Creative Peptides specializes in custom peptide synthesis, including modifications such as backbone alterations and the introduction of non-natural amino acids or functional groups, to meet your exact research needs.

We offer a wide range of peptide modifications, including Boc-, Fmoc-, and Cbz- protect groups, as well as fatty acid modifications, PEGylation, and peptide coupling with proteins or small molecules.

Our facilities are equipped to handle both small-scale and large-scale peptide synthesis, ranging from grams to multi-kilogram quantities, making it possible to scale production as your needs evolve.

We employ advanced technologies such as chemical synthesis, fermentation, and computer-aided drug design (CADD) to ensure the production of high-quality peptides with diverse structures and functionalities.

We provide comprehensive peptide analysis services, including purity testing, structural verification, and potency assessments, to ensure that your peptides meet the required specifications.

Using cGMP-grade peptides guarantees that the peptides meet industry standards for quality, consistency, and reproducibility, ensuring reliable results for research, development, and manufacturing.