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.
Cytovance Biologics Inc. announces development and manufacturing deal with NeuroFx for stem-cell-derived cell-free therapy for strokes.
CMC Biologics and River Vision Development announce manufacturing agreement for RV001, a monoclonal antibody to treat Grave’s orbitopathy.
Financial expectations for Baxter’s biopharma solutions arm will drop 10% as the result of a client’s decision to move its manufacturing in house.
FDA issues guidance regarding fees for drug compounding outsourcing facilities.
FDA issues draft guidance on dissolution testing for immediate-release solid oral dosage forms.
The broader aim of FDA's metrics initiative is to encourage quality manufacturing operations that will help avoid drug shortages.