BioOutsource partners with Glythera on ADC characterization
Contract Testing Organization (CTO) BioOutsource has partnered with Glythera to characterize their ADC (antibody drug conjugate) in development.
Archives for February 21, 2014
US FDA offers guidance on analytical procedures and methods validation for biologics
The US FDA has issued draft guidance to help the biopharmaceutical industry assemble information and present data to support its analytical methodologies.
EMA predicts 'no ADC influx' following Roche's Kadcyla launch
Antibody-drug conjugates (ADCs) are fully covered by current regulations, the EMA says, though a surge of applications is not expected in the light of Roche’s recent success.