Bioanalytical Services

1. Bioanalytical Services INQUIRY Proteins, or polypeptides, are organic compounds composed of amino acids. They are arranged in a linear chain and folded into globular form or other forms. Proteins are essential components of organisms and they participate in virtually every process within a cell. Many proteins are enzymes that catalyze biochemical reactions and are vital to metabolism. Not only are proteins a major structural component of living systems, they can also be effector molecules whose states determine downstream activities. Therefore, studying the protein characterization can reveal the mechanisms behind many of the cell’s responses to its environment. Given the vast number of applications for protein analysis, several tools and methods for its study exist; determining the correct method for your application is paramount to success. Proteins differ from each other according to the type, number and sequence of amino acids that make up the polypeptide backbone. Hence, they have different molecular structures and physiochemical properties. Protein analysis technologies are used to understand the unique and complex relationships between proteins. They are utilized in various applications including biomolecular interactions, enzyme kinetics, heterogeneity applications, immunogenicity testing and affinity characterization. These applications are useful in the pharmaceutical, research and quality control industries. Some features to consider in selecting a protein analysis method are sample size and type, automation, ease of use, integrated software, binding parameters, data quality assessment and assay portability. Some protein analysis methods might be better suited for particular applications so be sure to inquire to guarantee the best fit for your project. A workflow example for protein analysis Profacgen provides bioanalytical services for proteins using the most cutting-edge technology and experienced experts. Our services are fully flexible to your needs, and can be used as stand-alone tests or as a comprehensive package that could include: Biosimilar testing services For analytical and bioanalytical comparability of the biosimilar product Immunogenecity Assay

2. For detection and confirmation of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) supporting nonclinical and clinical studies Stability Analysis To detect, monitor and characterize proteins during formulation development Biopharmaceutical Process and Product Related Impurities Analysis To support bioprocessing validation and biologic product release in line with ICH Q6B We offer a full package of protein analysis to GLP/cGMP standards and is the perfect partner for customers looking to outsource your pharmaceutical and biologic product characterization services. We customize the service according to the specific requirements from the customers. Please do not hesitate to contact us for more details about our membrane protein modeling service. INQUIRY