Proteins & Peptides cGMP Manufacturing

The U.S. Food and Drug Administration (FDA) regulates biopharmaceutical manufacturing services through cGMP. As an experienced contract manufacturing organization, CD Formulation provides protein and peptide CGMP manufacturing services from laboratory scale to commercial scale to customers worldwide. Our team has abundant the expertise and experience to ensure compliance with strict quality standards, regulatory requirements, and production needs of all sizes.

What is cGMP?

cGMP stands for Current Good Manufacturing Practices (cGMP), a set of regulations established by regulatory agencies such as the U.S. Food and Drug Administration (FDA) to ensure the quality, safety, and effectiveness of drugs, foods, and medical devices. The cGMP guidance outlines minimum requirements for stringent quality control measures, documentation, and testing procedures throughout the protein and peptide manufacturing process from raw material procurement to final product distribution, including facility design, equipment maintenance, employee training, record keeping, and ensuring drug product identity, testing requirements for strength, purity and quality control. The implementation of cGMP can help pharmaceutical companies establish reliable production systems, improve product quality and consistency, and ultimately protect the safety and interests of the public.

Exploe Our Proteins & Peptides cGMP Manufacturing Services

CD Formulation has decades of experience in proteins and peptides cGMP Manufacturing. We focus on producing high-quality protein and peptide drugs for customers in compliance with cGMP standards, thereby helping customers bring drugs to the market faster. Whether you need to produce small batches of samples, conduct clinical trials, or large-scale commercial production, we can provide you with professional support and customized solutions.

• cGMP Proteins & Peptides Manufacturing

We provide one-stop services for cGMP protein manufacturing and conduct comprehensive control over the entire production process, from codon optimization, gene synthesis, and strain construction, to process development and preclinical production, achieving batch-to-batch consistency. In addition, our team can also produce up to 300kg of peptide raw materials through solid-phase methods and up to 50kg of peptide raw materials through solid-phase and liquid-phase synthesis processes.

• Proteins & Peptides Formulation cGMP Manufacturing

CD Formulation has multiple state-of-the-art, world-class drug product manufacturing facilities for the fill and finish of protein and peptide biotherapeutics and liquid or lyophilized parenteral drugs. Our proteins and peptides formulation cGMP manufacturing capabilities include but are not limited to tablets, injections, spray-dried powders, nanoformulations, aerosols, inhalants, and microneedles.

Fig.1 Proteins and eptides cGMP manufacturing.(CD Formulation)

Proteins & Peptides cGMP Manufacturing Capabilities

As experts in the manufacturing of complex and high-quality proteins and peptides and formulations, our extensive portfolio of manufacturing equipment and testing capabilities can meet any of your needs.

cGMP Manufacturing Facilities

• cGMP analytical laboratory.
• cGMP compliant production area.
• cGMP clean rooms and pilot plants.
• Milligram to kilogram cGMP production batches

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.

cGMP Analysis Equipment

• Solid phase, liquid phase reactor (20L-1000L).
• High performance liquid chromatography (HPLC).
• Freeze drying equipment.
• Microwave processing equipment.
• Multi-channel automation technology.

Why Choose Us for Proteins & Peptides cGMP Manufacturing?

• Always at the forefront of protein & peptide and its formulations manufacturing.
• Supports the manufacturing of a variety of formulations, including but not limited to tablets, injections, spray-dried powders, nanoformulations, aerosols, inhalants, and microneedles.
• Advanced GMP protein and peptide production facilities and analytical equipment.
• Comprehensive cGMP quality control and testing capabilities.
• Cost-effective and competitive price.

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.

How It Works

STEP 1

Submit a service request describing your specific research or development need.

STEP 2

We'll email you to provide your quote and confirm order details if applicable.

STEP 3

Execute the project with real-time communication, and deliver the final report promptly.