Monoclonal Antibodies (mAbs) are a kind of highly specific biological agents, can accurately identify combining with the specific to the target antigen epitope, widely used in the treatment of various diseases, such as cancer and autoimmune diseases, etc. The quality and characteristics of monoclonal antibodies directly affect their therapeutic efficacy and safety. However, the process of analyzing monoclonal antibody products can be challenging due to the size and complexity of the protein intermediates and the final drug.
Comprehensive analytical testing of monoclonal antibodies is a routine and important part of the biopharmaceutical industry. Protheragen-ING Lab offers a one-stop, regulatory-tested analytical solution for monoclonal antibodies. Our company can provide customized assay plans based on the specific needs of our clients and the characteristics of monoclonal antibodies.
Our Services
Protheragen-ING Lab is dedicated to providing integrated protein quality characterization services, including analysis of all aspects of monoclonal antibodies purity, product potency and identification, and non-cGMP in-process/scale-up optimization services.
In addition to monoclonal antibodies, Protheragen-ING Lab supports polyclonal antibody, antibody fragment, bispecific antibody, and antibody-drug conjugate evaluation.
Monoclonal Antibodies Analytics Method Development
When a complete cGMP characterization is not available as a solution for monoclonal antibody analysis, Protheragen-ING Lab provides customers with a panel of tests critical to the rapid turnaround time in a non-cGMP format. Commonly used tests include:
- Size, integrity, and purity of antibodies via capillary electrophoresis
- Protein concentration via NanoDrop
- Impurity analysis (including residual oligonucleotides by PCR, and residual proteins by ELISA)
- Binding by ELISA
- Cell based potency assays
Monoclonal Antibodies Raw Material Testing
Testing the purity and quality of the raw materials used in the culture and purification of monoclonal antibodies is essential for the efficacy and safety of the final product. Protheragen-ING Lab performs cGMP raw material testing using USP and custom validation methods and quickly provides accurate, traceable results and reports.
Stability Services
Cold chain stability studies are crucial for evaluating the stability of mRNA and LNP encapsulated drug products. Protheragen-ING Lab has a wide range of -80 ℃ and -20 ℃ stability capabilities and specialized cold chain products and freeze-thaw evaluation for critical assay controls.
Protheragen-ING Lab can help our customers with the following stability services:
- Stability protocol development
- Commercial Release Studies
- Clinical stage stability, with a major emphasis on stability indicator tests
- Formulation Development & Optimization
- Stability
- Freeze Thaw Studies
Monoclonal Antibodies Analytics Program
- Compendial
- Size Variants
- Charge Variants
- Glycosylation
- Potency
- Process impurities
- Excipients
- Concentration
- Safety
- Extended Characterization
Our monoclonal antibody analytical team includes experts with biochemistry, immunology, and biopharmaceutical backgrounds who are focused on providing in-depth analytical detection through industry-leading technologies and assays, and all steps of monoclonal antibody analytical are included.
Our monoclonal antibody analytics services are an important tool to ensure the safety, efficacy and quality of the final product. We are committed to helping customers reduce risks, improve product competitiveness and ultimately achieve market success through professional services.
Contact us today to learn more about our monoclonal antibody analytics services and see how we help our customers continuously optimize their monoclonal antibody development and production processes.