News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
Assessing key parameters of the upstream process to achieve high titer while maintaining desired integrity Customizing the downstream process to address the different needs from supercoil plasmid and linear isoform A platform approach with integrated...
Process characterization and validation is an important step in the product development journey and late-phase development, and it is required before transferring an existing manufacturing process.
Join us as our in-house experts, along with Cecile Bellamy from Pfizer, discuss current and future trends in biopharmaceutical raw material selection.
Medical science is continuously searching for better ways to administer drugs into the body and to maximize the therapeutic effectiveness of the drugs given.
The ability to amplify, modify and fabricate DNA is fundamental to modern molecular biology. Why do so many researchers take their constituent parts for granted?
Download the eBook written by Catalent experts to learn about innovative products and techniques for scale-up of complex biologics, get optimal cell culture medium and feed to maximize performance potential, novel analytical techniques for monoclonal...
The Cadence inline diafiltration (ILDF) device is designed for continuous processing, in-process buffer exchange or contaminant removal in various processes in a wide range of applications. This includes buffer exchange for final drug substance,...
At Pall we have supported the water intrusion test for more than 20 years and we developed the Palltronic® AquaWIT IV system to deliver fast and simple automated in-situ testing of gas and vent filters wherever they are located.
In September 2017, BioPharma-Reporter.com conducted its second annual ‘state of the industry’ survey on its user base of biopharmaceutical industry professionals. The key objective of the survey was to gauge views about the current state of the global...
The Cadence™ BioSMB platform from Pall Life Sciences is the first disposable flow path, continuous multicolumn chromatography solution that is fully scalable from the process development (PD)...
mAbs are produced for a number of therapeutic applications. However, mAbs are not a homogeneous family of products. Each mAb is unique, based on its isoelectric point, hydrophobicity and ability...
For many years cylindrical stainless steel tanks have been used in biopharmaceutical production.The primary reason for the cylindrical shape was that it provided the mechanical stability required...
Single-use bioreactors have only been cylindrical in design, until now. The Allegro™ STR single-use, stirred tank bioreactor provides advantages over the traditional cylindrical shape. Download...
In May 2016, BioPharma-Reporter conducted its inaugural ‘state of the industry’ survey. The key objective of the poll was to gauge views about the current state of the biopharmaceutical...
Pharmaceutical fluid transfer involves many tubing-to-fitting connections, and unfortunately those connections can leak and result in contamination, production delays, lost income and headaches....
Pall’s single-pass tangential flow filtration (SPTFF) technology provides a simple solution for continuous concentration and optimization of DSP steps. The Cadence™ Inline Concentrator (ILC)...
Pyrogens in pharmaceuticals, medical devices, biotherapeutics and cosmetics can cause fevers in humans and are potentially life-threatening. Yet standard pyrogen detection methods have drawbacks. The Limulus Amoebocyte Lysate (LAL) test only identifies...
Assessment of biosimilar molecules requires an orthogonal analytical approach. Any one particular analytical technique is not able to fully define the physical and biological characteristics of...