BioPharm International-05-01-2020

Material properties play a role in container closure integrity under frozen or cryogenic storage temperatures.

Risk aversion is impeding the use of closed aseptic systems, and adding unnecessary cost and complexity to aseptic operations in the pharma industry.

Questions and answers about contemporary closed-system design criteria for aseptic processing equipment

Pumps and other components meet the demands of single-use systems in biopharmaceutical downstream processing.

Will moving at “warp speed” to develop a vaccine impact efficacy or safety?

Next-generation therapeutics and regulatory requirements create demand for complex, fit-for-purpose tests.

Policy makers seek to ensure supplies of new therapies and to limit shortages.

Having a better understanding about compliance will be of benefit when looking for a job or for furthering one’s career, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.

Having remote operations in place is crucial to maintaining good automation practices.

The SLA5800 Series Biotech and the SLAMf Series Biotech are two new mass flow controller (MFC) models from Brooks Instrument designed specifically for improved gas flow control in biotechnology applications.

Tosoh Bioscience introduced the SkillPak 1 mL and 5 mL pre-packed columns for fast method development and resin screening of monoclonal antibodies, antibody constructs, oligonucleotides, proteins, and viruses.

The Nexera UC Prep, a preparative supercritical fluid chromatography (SFC) system from Shimadzu, works to provide maximum use of lab resources through flexible system configurations in a compact design that requires low installation space.

ReNu SU (single-use) Technology cartridge assemblies from Watson-Marlow Fluid Technology Group are designed for the development and production of personalized medicines.

In this peer-reviewed article, the authors present a series of experimental studies showcasing the performance of MMS in secondary-structure biopharma characterization and compare it with conventional FTIR data.

Synthetic biology has advanced the scope and scale with which biologically derived therapeutics can be developed.

Viral vectors show promise as a delivery mechanism for gene therapy, but which virus types are commercially viable?

The industry’s aversion to risk has led to its treating closed aseptic processing systems as miniature cleanrooms, resulting in redundant and expensive practices. This article ponders this impasse, examining new technologies and applications in light of past regulatory guidance and more than 40 years of operating evidence.

Click the title above to open the BioPharm International May 2020 issue in an interactive PDF format.

But are innovations sufficient to increase adoption? CMOs are demanding better continuous bioprocessing options.