Sartorius Stedim Biotech’s Sartoclear Dynamics is a clarification system designed to harvest mammalian cell cultures with high cell densities using single-use technology.
GEA’s Panther NS3006L high-pressure homogenizer is a standalone unit designed to reduce particle size to nanometer ranges.
Approaches to the generation of process models, optimization techniques, and application of a design space are explored.
The addition of a new manufacturing line at Lonza’s Portsmouth, NH site enables Alexion to add dedicated product supply for 10 years.
Evans Analytical Group expands into the pharmaceutical/biopharmaceutical industry with acquisition of ABC Laboratories.
Catalent’s licensing of Excelimmune’s antibody combination therapy platform can enable more consistent, cost effective production of antibody combinations.
While all market signs are pointing up, memories of past setbacks may discourage from expanding capacity.
EMA’s revised guideline on the implementation of accelerated assessment is open for public consultation.
The guidance provides recommendations for submitting analytical procedures and method validation data to FDA.
FDA warns an Arkansas compounding company that it is in violation of the FDCA.