A promising biologic candidate is only the beginning. Before progressing toward the clinic, developers need to understand whether a molecule can be manufactured effectively and whether potential quality or safety risks could affect its development.
Building a stronger foundation for biologics development
Lonza’s Early Development Services bring together manufacturability and developability assessment, protein expression, protein engineering, and immunosafety and immunogenicity evaluation to help identify risks earlier in development.
Assessment can provide insight into:
- Sequence liabilities that may affect manufacturability or safety
- Expression in a commercially relevant system
- Product quality risks, including aggregation or assembly issues
- Immunogenicity or immunotoxicity concerns
Protecting the potential of a promising asset
Understanding these risks earlier can support more informed decisions as candidates progress toward manufacturing and clinical development.
Read the article to learn how early development assessment can help identify risk sooner on the path toward IND.
