Month: December 2025
Sword Bio Expands Space to Support Growth
Sword Bio today announced that it has expanded into additional space to accommodate the rapid growth the company has experienced over the past year. The team has nearly doubled in size, driven by exceptional market response to Sword Bio’s commitment to scientific expertise, personalized service, and industry-leading lead times. With the newly added space, Sword…
Preparing for GLP and GCLP Compliance in Bioanalytical Studies
Bioanalytical laboratories sit at a critical juncture in drug development, supporting non-clinical toxicology/PK studies and human clinical trials. Ensuring compliance with both 21 CFR Part 58 (“GLP”) for non-clinical work and with Good Clinical Laboratory Practice (GCLP) frameworks for clinical sample analysis builds data integrity, regulatory trust and operational robustness. In this article we review…
Strategies for Immunogenicity Mitigation During Clinical Development
Immunogenicity—the immune system’s ability to recognize and respond to a therapeutic protein—remains one of the greatest challenges in biologics development. Unwanted immune activation can generate anti-drug antibodies (ADAs) that neutralize efficacy, accelerate drug clearance, or provoke hypersensitivity reactions. Even when responses are subclinical, they can compromise pharmacokinetics and increase interpatient variability. Because immunogenicity can arise…