From IND-enabling studies of biopharmaceuticals to post-commercialization support, EAG scientists find novel scientific ways to answer challenging development questions unique to large molecule development. Our dedicated scientists collaborate with clients as true partners, quickly addressing issues with “we know how” resolve. As a result, they have a proven track record for efficiently advancing complex programs through regulatory milestones.
EAG scientists bring deep insight to the analysis and characterization of Antibody Drug Conjugates (ADCs), monoclonal antibodies, biosimilars, fusion proteins, pegylated proteins and other biotherapeutics.
How do you understand the complexity of biotherapeutics? Turn to EAG. WE KNOW HOW.
HOW WE CAN HELP
From characterization of biopharmaceuticals to cell-based assays to routine testing, EAG supports every phase of the product lifecycle.
- cGMP Analytical Services: Comprehensive analytical support and quality control for biopharmaceutical intermediate, drug substance and drug product under GMP including: cell-based bioassays, capillary electrophoresis, SEC/MALS, UPLC and ELISA.
- Biopharmaceutical characterization: Our broad array of analytical techniques allows us to fully characterize biomolecules including sequencing, post-translational modifications (PTMs), glycosylation, charge variants and degradants, effectively addressing almost any regulatory requirement.
- Impurity and process testing: In-house expertise in the development, validation and analysis of process, product and host cell protein impurities to support release, stability programs, forced degradation studies, and product and process investigations. Product-related impurities include analysis of protein aggregates, deamidation, oxidation, sequence variants and truncations. Process related impurities include analysis of cell culture and downstream derived process components
- Preclinical/clinical support (GLP): Bioanalytical method development (ELISA VIS/FL/ECL) and validation in support of toxicology, pharmacokinetic studies and immunogenicity analysis in support of early phase and small-scale clinical trials.