cGMP Manufacturing is a key step to ensure that drugs comply with strict quality standards and regulations throughout the entire production process so that they can safely and effectively enter stages such as clinical trials, release, and commercialization. Leveraging years of accumulated experience in formulation manufacturing and successful projects, CD Formulation is committed to helping you achieve scale-up of your therapeutic protein and peptide formulations, and ultimately reach commercial production for marketing. We utilize a comprehensive cGMP formulation pilot plant dedicated to process development and optimization, preclinical trial batch drug production, and commercial production scale-up technology transfer to safely advance your drug product.

Explore Our Proteins & Peptides Formulation cGMP Manufacturing Services

CD Formulation is a technology-driven biopharmaceutical CDMO that provides integrated end-to-end services to support the entire development of therapeutic protein and peptide drugs, including pre-formulation studies, formulation development, analytical method development and validation, QbD-based process development, and commercial manufacturing and packaging, among others.

In our 4,000-square-foot GMP manufacturing facility, we develop and manufacture a variety of therapeutic line protein and peptide formulations to support preclinical and clinical trials. We are committed to being a top performer, from our facilities to our employees. We provide consistent cGMP proteins and peptides formulation cGMP manufacturing services to the highest standards and on your schedule.

We can handle a variety of dosage forms, from low-volume production for preclinical trials to high-volume commercialization, including:

Furthermore, our biopharmaceutical manufacturing team has extensive experience working with global regulatory authorities such as Europe (Ph.Eur.), the United States (USP), and Japan (JP), ensuring you receive comprehensive quality control services.

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 Formulation 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.
• Reliable manufacturing capabilities in lyophilized formulations as well as a wide range of vial and injectable formulations.
• Comprehensive cGMP quality control and testing capabilities.
• Reliable delivery and production schedules ensure customers can launch products on time.
• 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.