Manufacturing Standards Key to Advancing Cellular and Gene Therapies
FDA works with industry on strategies for assuring high-quality regenerative medicines.
The Role of the Quality Unit
The differences between the quality control and quality assurance units can be found in their names, according to Siegfried Schmitt, principal consultant at PAREXEL.
Using Simulation to Address Capacity Limitations
Modeling tools help process engineers optimize a biopharmaceutical facility’s capacity.
The Human Cost of Congressional Stalemates
Faced with divisive political and social issues, Congress must find a way to reach consensus.
Singular Developments Advance TFF Technology
Single-use and single-pass TFF devices are facilitating advances in biopharma manufacturing.
Glass or Plastic? Container Material Choices
Choosing a suitable material for fill/finish containers begins during the product development stage.
Real-Time Logistics
Internet of Things, advanced analytics, and blockchain solutions such as smart contracts promise to give manufacturers more control over products and supply chains.
The Immune Context in Microbiological Testing
The control of biologics microbiological impurities, contaminants, and mimetics is evolving.
Impact of Media Components on CQAs of Monoclonal Antibodies
The authors review how media components modulate the quality of monoclonal antibody products
Top Trends in Biopharmaceutical Manufacturing, 2017
Innovation speeds discovery, drives down costs, and improves productivity.
Bioburden Control in the Biopharmaceutical Industry
Protecting against microbiological contaminationover the whole manufacturing process grows increasingly important.
BioPharm International, September 2017 Issue (PDF)
Click the title above to open the BioPharm International September 2017 issue in an interactive PDF format.
