PI is becoming increasingly well-understood and its utility is continuously evolving to meet specific manufacturer needs, from product development to manufacturing, whether approached stepwise or end-to-end.

Receiving customer forecasts as early and as completely as possible is critical to the success of the supply chain continuum.

As biopharmaceutical manufacturing grows increasingly global, the production and transport networks required to keep operations running smoothly become more complex.  This paper provides a framework for making challenging decisions linked to cold chain management before outlining potential solutions that could solve many of the issues surrounding the frozen transfer of biopharmaceuticals.

The seamless functionality of single-use technology equipped with a scalable distributed control system (DCS) empowers you to capture the benefits of collecting and sharing data while simultaneously creating a connected enterprise that grows with the pace of your business.

The use of single-use technologies has been growing steadily over the past decade, but there are challenges. Explore the potential solutions for single-use supply constraints.

Glympse Bio is developing bio-engineered, in-vivo diagnostic technologies that could offer biologics developers earlier insight into target engagement and therapeutic response. That spells big implications on translational research, speed to clinic, and time to market.

The potential logistical benefits of the VIA Capsule™ system for the cryogenic transportation and short-term storage of cryopreserved cell products was evaluated. CSL Behring gathered data from two independent shipments from Pasadena, California, to King of Prussia, Pennsylvania, and back, using the VIA Capsule™ shipper.

Since it is not possible to anticipate every possible transport route, a set of industry-recognized tests was selected to represent a challenging use scenario. The two main risks to frozen material during transport are mechanical and thermal. In this note we have evaluated the  Celsius® FFT | FFTp Box Shipper and Celsius® FFT | FFTp Bulk Shipper using the ASTM D-4169 test for mechanical risks and the ISTA 7D test for thermal risks.

As the demand for plasmid DNA (pDNA) based gene therapy and vaccines increases, large-scale, cost-effective, and reproducible pDNA production is required. The key to success is a real-time in-process control method that ensures a high percentage of supercoiled pDNA in the final product. Read how the CIMac™ pDNA Analytical Column allows the monitoring of degradation products (open circular and linear pDNA), the removal of impurities (RNA), and ensures that each production step yields the amount of supercoiled pDNA anticipated.

A biopharmaceutical manufacturer was looking to reduce the operating costs of existing purification steps with high resin costs. In this case study they review transferring an existing batch chromatography process into a multi column format and then scaling up that process to an continuous perfusion run. The result was a dramatic reduction in protein A resin requirements.