Lonza Introduces Risk Assessment Platform for Biopharmaceuticals
The Developability Assessment Platform evaluates manufacturability and safety in discovery and early-stage biological drug development.
Early risk assessment has become a crucial factor in biopharmaceutical drug development programs. To address this growing market need, Lonza launched a Developability Assessment Platform that is designed to reduce attrition rates and improve the ranking of early drug candidates, according to a press release. The prediction tools include a suite of in silico-based services that assess candidates for fitness for large-scale manufacture (manufacturability) and immunogenicity profiles in humans (safety).
The manufacturability assessment service analyzes chemical degradation pathways and post-translational modifications, including deamidation, oxidation, and glycosylation, as well as potential physical stability issues, such as protein aggregation. The safety assessment service uses Lonza’s proprietary Epibase in silico screening tool to identify potential T-cell epitopes in target proteins that may trigger potential immune reactions in human studies.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
FDA Reopens Comment Period on HCP Immunogenicity Risk of Follow-on Recombinant Peptides
January 2nd 2025FDA is reopening the comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, until March 3, 2025.
