Manufacturing Equipment, Upstream Processing

The platform combines an expression system with equipment and process controls to enable rapid development and scale-up of robust titers.

The company announced the launch of its first-in-class Lynx CDR connectors at INTERPHEX 2016.

Flexsafe 3D Pre-Designed Solutions feature appropriate components, functionalities, and quality controls that meet the specific requirements of each step in upstream and downstream processing and in final filling.

Andrew Bulpin, executive vice president of EMD Millipore’s Process Solutions Business, speaks to Pharmaceutical Technology about the trends shaping the biopharmaceutical manufacturing industry.

EMD Millipore will provide process development services for Precision Biologics’ preclinical monoclonal antibody.

Innovative polyethylene film sets new benchmark

What challenges do biopharmaceutical manufacturers face when deciding to move from a fed batch process to a continuous process?

Both upstream and downstream processes can benefit from continuous manufacturing advantages.

Consider these best practices when deciding to implement single-use components.

Budgets for biopharmaceutical activities are gaining in select functional areas except outsourcing.

Critical issues that should be considered when scaling up a hot-melt extrusion process.

The standardization of upstream and downstream bioprocessing is growing, but several kinks need to be ironed out.

Experts discuss solutions for filter bacterial retention and related challenges. Contains online bonus material.

In a 2004 guidance, FDA says that the "use of redundant sterilizing filters should be considered in many cases." But not all manufacturers agree on what redundant filtration is.

A recent industry survey shows keen interest in improving bioreactors and cell-culture media.

Life-sciences companies spend proportionally more resources on information technology and get less in return on their investment than companies in other industries. The poor return on investment partly results from regulatory costs that are unique to the pharmaceutical industry, but also stems from a failure to manage data strategically.

Drugmakers have the common goal of manufacturing safe and sterile pharmaceutical products and understand that the filtration process is a critical means of achieving this goal. Preuse filter-integrity testing provides evidence that a filter will perform correctly, has the right pore size, and has been installed correctly.

A look at the true cost-drivers of cell-culture production.