Analytical Method Development Services
With more than 50 years of experience in providing fast, flexible analytical method development services, we ensure the quality, identity, purity, and potency of your product in strict accordance with all cGMP manufacturing guidelines. Our extensive expertise using a broad spectrum of analytical methods enables a robust analytical control strategy that is suited to your specific product.
From the Analytical Development Laboratory to the Analysis of cGMP Production
We are an end-to-end CDMO partner, providing expert analytical support for your product from Phase I through cGMP-compliant commercial production. Our customized services include analytical method development, establishment, and qualification, as well as cGMP-compliant validation and method transfer. All analytical methods are aligned with current ICH guidelines and the requirements of international regulatory authorities.
Expertise in All Common Protein Formats
Our clients value and depend on our deep analytical development expertise with complex proteins and active ingredients. We have decades of experience implementing and supporting a wide array of analytical methods for biosimilars, bispecific antibodies, coagulation factors, enzymes, Fc fusion proteins and monoclonal antibodies.
Expertise With State-of-the-Art Analytical Method Development
Our leading-edge methods and broad portfolio of high-quality work ensure the rapid development of stable and efficient analytical methods. We fully support your journey to commercialization, providing both standardized methods and individually adapted solutions that move you forward.
Product and method characterization utilizing mass spectrometry
Precision meets innovation in our mass spectrometry facility. Our customer-focused laboratory harnesses the power of cutting-edge technology to deliver accurate, reliable and timely results for all analytical needs. We offer MS methods for protein characterization and qualitative and quantitative analysis of critical quality attributes (cQA). Our team of experienced scientists and technicians is dedicated to providing both standardized and customized solutions at all stages of the product life cycle.
Success through product expertise
Our product expertise in the biopharmaceutical industry, with a focus on Critical Quality Attributes assessment and an integrated Quality by Design approach, provides comprehensive solutions to ensure your development and manufacturing success. Our team of experts uses state-of-the-art techniques and methodologies to evaluate and control critical attributes throughout the product life cycle - from early development to commercialization.
Our Analytics Portfolio
Our Track Record in developing Analytical Methods
Get in Touch with our Business Development Team
Are you interested in learning more? We look forward to hearing from you.