Cell line development
Stable CHO/HEK lines, clone screening, productivity optimization, and monoclonality documentation.
Services
We support biologics programs across the development lifecycle.
Upstream & downstream process
Scalable fed-batch processes, purification strategies, and robustness studies to prepare for GMP scale-up.
Analytical development
Method development, product characterization, and comparability packages aligned with regulatory expectations.
Regulatory documentation support
Technical content for CMC sections and supporting appendices to streamline IND/IMPD submissions.