Developing a biologic candidate for clinical studies requires early identification of potential risks that could impact safety, manufacturability, efficacy, and regulatory success. Lonza's Early Development Services (EDS) help developers make informed decisions during critical early-stage development through predictive assessments, scientific expertise, and integrated development support.
This brochure highlights how we help biopharma innovators de-risk development and accelerate progression from discovery to first-in-human studies through:
- Developability and manufacturability assessments to identify sequence- and structure-based liabilities that may impact product quality, yield, stability, or cost.
- Immunogenicity and immunotoxicity evaluation using Lonza's proprietary Epibase® platform, combining in silico and in vitro approaches to support lead selection, optimization, and regulatory submissions.
- Antibody humanization and deimmunization services to reduce immunogenicity risk while maintaining desired molecular characteristics.
- Non-GMP protein expression and characterization services powered by the ; to rapidly generate representative material for testing and development.
- Formulatability assessments that evaluate stability and solubility while helping address development challenges early in the molecule lifecycle.
- Support across multiple modalities, including biologics, bioconjugates, mRNA-based therapies, inhaled biologics, and cell and gene therapies.
Supported by a globally integrated network of scientific experts and development facilities, our EDS team helps innovators reduce risk, accelerate development timelines, and improve confidence in advancing candidates toward clinical milestones.
Download the brochure to learn how Lonza's Early Development Services can help de-risk your molecule and accelerate the path to first-in-human studies.
