Quality control in biologics development and manufacturing involves a range of activities, including testing raw materials, monitoring manufacturing processes, and evaluating the final product for purity, potency, and stability. CD Formulation provides fully integrated proteins and peptides quality control and release testing, from analytical method development, validation, and transfer, to batch release testing. We view quality control as an important step in the development and production of therapeutic proteins and peptides, ensuring your products are of the highest quality.

The Importance of Quality Control and Release Testing

Biopharmaceuticals, including therapeutic proteins and peptides, are complex products that require a combination of complementary analytical testing to ensure their batch-to-batch consistency and continued quality. Regulatory guidance states that quality attributes for different product categories should be included in product release specifications. While the continued development of sophisticated physicochemical techniques has made them increasingly powerful in defining product identity, integrity, purity, and consistency of manufacturing processes, the results produced are not easily related to biological activity. Therefore, quality control often requires a series of bioassays to determine product purity, identity, and potency to ensure product safety and effectiveness.

Explore Our Proteins & Peptides Quality Control and Release Testing

Due to their special properties, biological products such as proteins and peptides require specific scientific expertise and regulatory knowledge. CD Formulation specializes in developing and validating robust bioassays according to cGMP to assess the potency and bioactivity of your therapeutic proteins and peptides. Our specific services for quality control testing of therapeutic protein & peptide biologics include but are not limited to:

• Proteins & Peptides Analytical Method Development
• Proteins & Peptides Analytical Method Validation and Transfer
• Proteins & Peptides Product-related Impurity Analysis
• Proteins & Peptides Process-related Impurity Analysis
• Proteins & Peptides Elemental-related Impurity Analysis
• Proteins & Peptides Residual Solvent and Volatile Impurity Analysis
• Proteins & Peptides Extractables and Leachables Analysis
• Proteins & Peptides Residual Host Cell DNA Testing
• Proteins & Peptides Residual Host Cell Protein Analysis
• Virus Clearance Testing
• Cell Line Characterization
• Proteins & Peptides Biosimilarity Studies
• Proteins & Peptides Comparability Studies
• Proteins & Peptides Stability Testing
• Proteins & Peptides Forced Degradation Studies
• Proteins & Peptides Batch-release Testing

Fig. 1 Quality control strategies for protein & peptide. (CD Formulation)

Our Expertise

Analytical Method Development and Validation

We provide fully integrated end-to-end services, from analytical method development, validation, and optimization to transfer. Our services include the development of analytical methods for a variety of therapeutic protein and peptide bioproducts, including but not limited to, purity (size, charge-based) analysis such as SE-HPLC, RP-HPLC, iCE280, and CE-SDS, identity, content, and potency assays (cell-based, ELISA, etc.).

Our team of protein & peptide experts has extensive experience in method validation and has successfully developed standard assays for monoclonal antibodies, bispecific antibodies, other recombinant proteins, fusion proteins, antibody-drug conjugates, and therapeutic peptides.

Obtain Comprehensive Quality Control Data

Our therapeutic protein and peptide drug product quality control releases and cGMP drug product stability testing are conducted in accordance with ICH guidelines. Our analytical experts will proactively work with you to plan and execute GMP activities to enable clinical and commercial testing.

Importantly, we can help define shelf life, and specification and develop drug product control strategies for INDs or BLAs.

Supporting Special Analytical Services

In addition to routine analytical testing services, our state-of-the-art professional analytical testing laboratories support the following special services, including but not limited to:

• Particle control and characterization strategies in therapeutic protein and peptide production and manufacturing.
• Extractable and leachable characterization of packaging materials.
• Excipient degradation agent characterization.
• Container closure system design and tightness testing.
• Visible particle characterization.

Our Technologies

Biosafety: Includes sterility testing, mycoplasma testing, and viral clearance testing.

Purity: Content determination based on SE-HPLC, RP-HPLC, iCE280, and CE-SDS, as well as impurities detection and quantification,  such as host cell residual impurities, based on qPCR and ELISA.

Identity: Includes qPCR/RT-qPCR-based tests, and mass spectrometry-based tests such as liquid chromatography-mass spectrometry (LC-MS) or tandem mass spectrometry (MS/MS).

Biology potency: Titrations, cell-based assays, ligand and receptor binding assayss, and in vivo potency assays.

Why Choose Us for Proteins & Peptides Quality Control and Release Testing

• We have years of experience in conducting quality control and release testing for proteins and peptides, ensuring accurate and reliable results.
• Our laboratory is equipped with the latest technologies and instrumentation to perform comprehensive testing for protein and peptide analysis.
• Our team of scientists has expertise in method development for proteins and peptides, ensuring that we can customize testing protocols to meet your specific needs.
• We adhere to strict quality standards and regulatory guidelines to ensure that all testing is conducted in accordance with industry best practices.

Publication

Quality control and release testing are critical components to ensure safety, efficacy, and consistency in the development and manufacture of therapeutic proteins and peptides. Please feel free to contact us if you are interested in our services or have further questions. We look forward to working with you to promote development and innovation in the biopharmaceutical field.