Technical Report No. 56 (Revised 2026) outlines a GMP--compliant, phase--appropriate quality management system (QMS) spanning preclinical development through clinical phases and commercial readiness ...
Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...
Announcing a new article publication for BIO Integration journal. Clinical trials bridge basic research and clinical application, serving as essential steps in drug development. This review examines ...
Overcoming common challenges with today’s biologics, such as developing devices for high-concentration subcutaneous ...
The collaboration marks a turning point in AI-driven drug design and trial forecasting, de-risking the drug development process for industry and patients. Our two companies are applying AI in ...
GenScript, a global leader in life science research tools and services support, has expanded its mRNA synthesis and formulation capabilities with the launch of a GMP-like mRNA manufacturing service, ...
ImmuneOncia Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on immuno-oncology, and Lonza, one of the ...
April 10 (Reuters) - The U.S. Food and Drug Administration said on Thursday it plans to replace animal testing in the development of monoclonal antibody therapies and other drugs with "human-relevant ...
Ofichem, a Netherlands-based CDMO, acquired Meribel Pharma Solutions’ site in Uppsala, Sweden, to support early-phase, IP-driven drug substance development and to expand its non-GMP capabilities in ...