Therapeutic protein and peptide drugs are successfully advanced into the clinic and achive commercializing  requires seamless expansion into GMP manufacturing activities to cost-effectively manufacture therapeutic proteins and peptides with the required CQAs. How to ensure efficient manufacturing and mass production under GMP conditions is an issue that many pharmaceutical companies urgently need to solve. In order to cope with these complex challenges, CD Formulation has established a completely synthetic process platform for cGMP Proteins and peptide synthesis, and is committed to providing GMP-level manufacturing services to our customers.

What are cGMP Proteins & Peptides?

cGMP protein & peptide are not proteins or peptides, such as monoclonal antibodies or cyclic peptides. Rather, it is a regulatory standard for the production and control of therapeutic proteins and peptides, ensuring that they meet therapeutic requirements and safety standards, especially when they are used in clinical trials as well as specific stages such as commercialization. Generally, the manufacturing and production of cGMP proteins and peptides follow process development procedures, and pharmaceutical companies need to transfer the feasibility study step verification process to the cGMP workshop to ensure that clinical trials and commercial production processes will not change. cGMP proteins and peptides manufacturing requires strict quality control and supervision, including selection and verification of raw materials, control of production processes, purification and analysis of products, and management of records and documents. Only through strict cGMP manufacturing can we ensure reliable product quality and meet regulatory requirements.

Explore Our cGMP Proteins & Peptides Manufacturing

As the world's leading biopharmaceutical contract manufacturing organization, CD Formulation has decades of experience in cGMP proteins and peptides manufacturing services, specializing in providing high-quality production services to global customers and ensuring compliance with cGMP standards and regulatory requirements.

Our state-of-the-art cGMP-compliant manufacturing facilities are designed for multi-product manufacturing and provide comprehensive support from therapeutic protein and peptide drug development, IND filing, and clinical trials to commercial production, covering all aspects of protein and peptide expression, purification, modification, structural analysis, stability assessment, etc.

We firmly believe that every client's project is unique and our scientists will work closely with you to ensure your project goes smoothly. Importantly, we also provide customized solutions that are adjusted and optimized according to customer needs.

Our Solutions for cGMP Proteins & Peptides Manufacturing

CD Formulation provides process development and cGMP manufacturing services for therapeutic proteins and peptides. We have ready access to state-of-the-art biopharmaceutical product development and manufacturing facilities, ensuring high-quality, efficient service. We are committed to building long-term relationships with our customers and providing them with ongoing support and services in the following areas, including but not limited to:

Comprehensive cGMP Quality Control and Testing Capabilities

• Analytical method development and validation.
• Solubility testing.
• Molecular weight testing.
• Amino acid sequence analysis.
• SDS-PAGE for protein analysis.
• Endotoxin level testing.
• Host cell DNA content assessment.
• Host cell protein content measurement.
• Extractables and leachables analysis.
• Biological activity and functional assessment.
• Forced degradation analysis.
• Microbiological limit testing.
• Comprehensive stability test data.
• Batch release testing.
• Process transfer.

Why Choose Us for Proteins & Peptides cGMP Manufacturing?

• Always at the forefront of the manufacturing of therapeutic proteins and peptides and their formulations.
• Advanced GMP protein and peptide production facilities and analytical equipment.
• Support throughout the drug development process from therapeutic protein and peptide discovery to CMC.
• Regulatory support strategies for therapeutic proteins and peptides.
• Comprehensive cGMP quality control and testing capabilities.
• Cost-effective and competitive price.

Publication

Comprised of experienced protein chemists and formulation engineers, CD Formulation focuses on developing and producing protein and peptide drugs that meet global cGMP standards for customers to address complex biotechnology challenges. Please don’t hesitate to contact us if you are interested in our services. We look forward to cooperating with you.