Proteins & Peptides Analytical Method Development

Developing reliable analytical methods is a critical step in the development and manufacturing of any protein/peptide biopharmaceutical, helping to ensure critical quality attributes (CQAs) of the product and supporting quality control and batch release testing. As one of the global leaders in protein and peptide formulation science and manufacturing, CD Formulation's protein characterization team provides bioanalytical method development and validation services that follow current USP/EP/ICH guidance. These services are applicable to a variety of therapeutic products such as monoclonal antibodies (mAbs), fusion proteins, bispecific antibodies, antibody-drug conjugates (ADCs), and more.

Importance of Analytical Method Development

Before any protein/peptide therapeutic enters clinical trials, analytical methods must be developed and validated during drug development to ensure the safety, purity, and efficacy of the candidate drug during manufacturing. Regulatory agencies require that appropriate analytical methods must be developed to accurately determine the identity, potency, purity, and concentration of proteins/peptides and their associated impurities. These methods are essential to monitor drug quality throughout the manufacturing process and ensure consistency between batches. Validation of analytical methods is also necessary to demonstrate that these methods are suitable for their intended use and have acceptable levels of accuracy, precision, specificity, and sensitivity. This validation ensures that the results obtained from the analytical methods are reliable and can be used for decision-making during the drug development process.

Explore Our Proteins & Peptides Analytical Method Development Services

Protein/peptide biopharmaceuticals are a class of complex drugs that require specific expertise and extensive experience to support accurate, selective, and robust analytical method development and validation. With decades of in-depth understanding of protein/peptide biopharmaceutical testing experience and support from advanced technologies and equipment, CD Formulation provides a wide range of protein/peptide biologics analytical method development and assay validation services based on cell and animal models for the characterization of recombinant proteins, antibodies, fusion proteins, antibody conjugates and peptides.

We provide fully integrated end-to-end services from analytical method development, validation, and optimization to transfer. Our services involve a wide range of analytical methods development, including but not limited to purity, identity, content, and potency assays (cell-based, ELISA, etc.), for therapeutic protein and peptide bioproducts.

Fig. 1 Key indicators for protein/peptide analysis method development and characterization. (CD Formulation)

• Pharmacopoeia testing, including pH, osmotic pressure, conductivity, extractable, appearance, and bioburden.
• Protein/peptide characterization analytical method development, including primary/high-order structural analysis, peptide mapping, particle and aggregation characterization, quantitative analysis, amino acid analysis, post-translational modification (PTM) analysis, etc.
• Protein/peptide quality control analytical method development, including product-related impurity analysis, process-related impurity analysis, extractables and leachables analysis, as well as elemental and residual organic solvent analysis.
• Protein/peptide bioactivity analytical method development, including immunogenicity analysis and in vitro cell-based potency assay.
• Protein/peptide formulation analytical method development, including encapsulation efficiency, drug loading rate, in vitro release testing, in vitro penetration testing, and pharmacopeia testing.
• Protein/peptide stability study method development, including in-process intermediate holding stability (during purification), freeze-thaw stability, and pre-formulation buffer stability studies.
• Protein/peptide forced degradation study method development, including limited or extended forced degradation stability assessment.

Our Analytical Technologies

Our team of protein and peptide experts has extensive experience in any analytical method development and has successfully developed standard assays for monoclonal antibodies, bispecific antibodies, other recombinant proteins, fusion proteins, antibody-drug conjugates, and therapeutic peptides. We apply the following advanced technologies to support any type of protein/peptide characterization and testing.

• HPLC: Reversed phase, size exclusion (SEC), ion exchange (IEC), hydrophobic (HIC), hydrophilic (HILIC).
• ELISA: Potency, host cell proteins (HCP), host cell DNA, residual contaminants, immunogenicity.
• Gel electrophoresis: Sodium dodecyl sulfate (SDS) and isoelectric focusing (IEF).
• Capillary electrophoresis (CE): SDS and capillary isoelectric focusing (cIEF).
• Western blot.
• UV-visible assays: 280nm UV absorption, Lowry assay, BCA assay, Biuret assay, Bradford assay, and WST assay.
• Cell-based potency assays (in vitro).
• Animal models-based potency assays (in vivo).
• Raw material authentication, such as cell line, according to USP and EP monographs.

What Problems Can We Solve?

• Development of new analytical methods.
• Optimization of existing analytical methods.
• New/existing analytical methods validation and verification, conduct thorough method suitability testing, including accuracy, precision, reproducibility, repeatability, specificity and selectivity, the limit of detection (LOD), the limit of quantification (LOQ), linearity, range, stability, and revalidation.
• New/existing analytical methods transfer, develop a comprehensive analytical method transfer protocol to ensure accurate and reliable testing results when transferring analytical methods from one laboratory to another.

Why Choose Us for Proteins & Peptides Analytical Method Development？

• We master the most advanced technologies and methods in the protein/peptide biopharmaceutical industry and can solve any challenges of protein drug analysis.
• We have hundreds of achievements in protein/peptide analysis method development.
• Our scientists will work with cross-functional teams to ensure consistency in method development and optimization strategies.
• We adhere to strict quality standards and regulatory guidelines to ensure that all testing is conducted in accordance with industry best practices.
• We provide support throughout the development and manufacturing of your protein/peptide biologics.
• We provide flexible experimental options and customized solutions to meet the needs of different customers.

Publication

CD Formulation is committed to providing integrated protein/peptide analysis method development and validation services, from early formulation development to pre-market batch release testing. Our team consists of experienced chemists and protein scientists with advanced instrumentation and expertise. Whether you want to develop a new method or optimize an existing legacy method, we can provide professional technical support and services. Please feel free to contact us if you are interested in our services or have further questions.

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.