Biologics Developability
Just as Lipinski’s “rule of 5” became a “rule of thumb” for evaluating and developing small molecule pharmaceutics with drug-like properties and desirable bioavailability, a set of “rules” has begun to coalesce in recent years for the development of biologics with reduced risk of attrition during clinical development due to manufacturability issues or other liabilities that can be listed under the umbrella of “developability issues”, including undesirable PK/bioavailability, off-target safety risks, and immunogenicity.
Experimental assessment or in silico analyses of properties related to developability risks is crucial in (1) shaping lead molecule optimization strategy, (2) supporting selection of a final drug candidate molecule for progression into manufacturing, GLP toxicity studies, and other preparations for human clinical trials, and (3) reducing attrition and failure of therapeutic molecules in clinical trials. During the development stage, developability evaluation focuses on assessment of critical quality attributes (CQAs) and quality control of product and manufacturing process-related impurities to ensure safety and efficacy.
Here, we feature articles reflecting the latest thinking across the industry on the topic of biologics developability. This collection narrates the recent advancements in the field covering early stage developability assessment, and practical considerations, new technologies and strategies for CQA assessment and control systems at later stages of drug development. We thank the authors for their contributions and hope this collection of reviews will stimulate continued efforts, innovation, and refinement in the field and ultimately, meaningfully decrease attrition during biologics development.
Edited by
Dr. Nathan Higginson-Scott(Seismic Therapeutic)
Dr. Feng Yang(Genentech)
Dr. Li Zhou(AbbVie)