Method Establishment

Comprehensive analytical development services at every phase of the project cycle.Learn More

Formulation Development

Developing robust, optimized formulations to maximize therapeutic performance and clinical outcomes.Learn More

Release and Stability

Release and stability programs reliably evaluate the quality, safety, and efficacy of biotherapeutics at release and during long term storage.Learn More

Compatibility and In-Use Stability

Evaluation of critical quality attributes (CQAs) using selected drug product administration clinical protocols to minimize patient risk and improve clinical outcomes.Learn More

Rapid Analytics

Ad-hoc analytical testing including mass spectrometry, particle forensics, analytical ultracentrifugation, biophysical characterization testing.Learn More

Automated Plate-Based Assays

Ad-hoc analytical testing for plate-based assays using our state-of-the-art high-throughput and automated platforms.Learn More

Cell Based and Binding Assays

Development and testing services to evaluate product potency based on biological mechanism of action. Robust method support from product characterization through commercialization.Learn More

Product and Process Characterization

Comprehensive range of biophysical, biochemical, and biological characterization services including high resolution mass spectrometry, cell-based assay, particle forensics, and biophysical core technologies.Learn More

Comparability

Analytical comparability studies rigorously assess CQAs from pre- and post-change lots for a reliable comparison of the product quality, safety, and efficacy.Learn More

Similarity

Biosimilar licensure requires demonstration of bioequivalence to a reference biologic. Similarity studies assess physical, chemical, and biological properties to support claims of equivalent safety and efficacy.Learn More

Consulting

Expert consulting services for biopharmaceuticals, providing strategic guidance to optimize product development and manufacturing processes.Learn More

Developability

Comprehensive developability assessments to evaluate molecule stability, manufacturability, and efficacy at every stage of the development pipeline.Learn More

Microbial Cell Line Development

Microbial expression that ensures product quality, safety, and titer across proteins and at scale.Learn More

Mammalian Cell Line Development

CHO-based mammalian expression for robust and versatile cell line development with high productivity and performance, matched to your molecule and needs.Learn More