Pharmaceuticals, Biopharmaceuticals and Generic Drugs
EAG scientists have worked with virtually every class and type of compound, across most indications and all common formulations of pharmaceuticals, biopharmaceuticals and generic drugs. We have helped hundreds of companies like yours overcome R&D roadblocks, defend their patents, respond to regulators and uncover sources of problematic manufacturing issues.
HOW WE CAN HELP
From formulation analyses to contaminant and packaging investigations, the scientists of EAG support every phase of the drug product lifecycle.
- Composition & surface analysis: We offer comprehensive analysis of layer structure and chemical composition, evaluation of particle size and composition, chemical imaging of drug and drug product, as well as the quantitation and distribution of active ingredients, excipients and coatings at the sub-micron scale
- Deformulation: Also known as reverse engineering, deformulation is the separation, identification and quantitation of ingredients in a product. Whether you are developing a generic equivalent or defending your own IP, turn to EAG for deformulation expertise.
- Biosimilar analysis: Biosimilars are, by their very definition, close but not exact replicas of an innovator biopharmaceutical. When it comes to defending your patent or avoiding patent infringement, no commercial lab has more experience. Services include peptide mapping, post-translational modification (PTM) identification, intact analysis, and drug antibody ratio (DAR) calculations for antibody drug conjugates (ADCs), as well as expert witness services.
- Trace analysis & structural chemistry: EAG brings multi-disciplinary expertise to the isolation, elucidation, identification and characterization of trace levels of knowns and unknowns, including contaminants in packaging, ingredients and final products, and extractables and leachables.
- Custom synthesis: From reference standards and test articles to stable-labeled active ingredients, turn to EAG. We have extensive experience with multi-step and other complex synthesis projects, and our comprehensive, in-house analytical services ensure quick turnaround of purity and structural confirmation.
- Consulting & litigation support: EAG maintains a team of scientists and engineers who provide technical consulting, problem solving and litigation support, including expert testimony for patent violation investigations, product liability and other legal issues.
- Specialized pharmaceutical services: EAG is well known for investigative problem-solving. Whether you’re dealing with a black speck, off color, packaging failure or some other problem, our troubleshooting experts have a stellar track record for identifying root cause quickly.
For other preclinical, clinical and CMC development services, please contact our colleagues at Eurofins Biopharmaceutical Product Testing. For environmental risk assessments, turn to Eurofins Regulatory Science Services.