Advanced Analytical Development and Characterization

Enzene Advanced Analytical Technologies (AAT) team consists of highly skilled biochemists, analytical chemists and biologists with several years of experience in biotherapeutic analytical development. Our state of the art facility is fully equipped for in-depth product characterization, biosimilarity enabling physicochemical studies, purity/impurity method development, qualification and validation. We support process analytic for cloning, process and product development teams. We develop release assays for PCS, CT and commercial manufacturing processes.

Capabilities

Analytical strategies are available to characterize various therapeutic proteins such as small peptides, hormones, glycoproteins, monoclonal antibodies, phytopharmaceuticals etc.
Various analytical method development for process intermediates, drug substance and drug product release.
Designing strategies and establish biosimilarity with innovator product and investigational product using advanced analytical technologies.
Analytical method development and its qualification as per regulatory guidelines.
Extensive product characterization using advanced analytical tools such as peptide map analysis coupled with mass for primary structure analysis, intact and reduced mass analysis, secondary, tertiary and high order structure analysis, charge variant analysis, size and product related variant analysis.
Impurity profiling and characterization.
Identification and quantification of glycoforms in glycoproteins.
Design and experimentation of protein stability study as per regulatory guideline.

Infrastructure

We have advanced analytical tool for protein characterization, such as

ESI Q TOF Mass spectrophotometer for intact mass, reduced mass, peptide map analysis.
CD Spectrophotometer for secondary structure analysis
Capillary electrophoresis using PA800 plus
High pressure liquid chromatography (HPLC)
Ultra Performance Liquid Chromatography (UPLC)
Electrophoresis equipment like SDS PAGE, IEF, Western blot analysis.
Freeze dryer from Thermo scientific.