Althea announces first phase of ADC offerings
Althea is expanding its biological drug product manufacturing operations to include highly active materials, such as Antibody Drug Conjugates (ADCs).
Archives for December 16, 2015
More systems training needed to help inspectors spot data falsification say PIC/S experts
Data falsification at API facilities is getting harder to spot say regulators who have called for more systems training and international collaboration.
IPO ready BeiGene adopts GE tech for China cancer biologics plant
Nasdaq-bound Chinese biopharma BeiGene has chosen GE Healthcare’s Flexfactory platform for the monoclonal antibody (mAb) plant it is building in Suzhou.
Growing imbalance in research funding raises concern, NIH responds
Researchers are concerned about trends which suggest a growing imbalance between commercial and academic funding.
FDA updates definitions: what constitutes a manufacturing site change?
The FDA is seeking comment on a draft guidance which outlines the administration’s thoughts on what constitutes a manufacturing site change.