News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
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.
When Arcturus presented its mRNA vaccine candidate to Recipharm, it was at the stage of a frozen product, a ready-to-administer sterile injectable for Phase I & II clinical trials.
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?
The clinical value of biologics for the treatment of many disease indications has been accompanied by phenomenal sales. By 2026, the global market for biologics is projected to increase to $537 billion, while the blockbuster Keytruda could be the...
As the world grapples with the effects of ongoing health crises, the market is expanding quickly as developers shift their focus to proactive therapeutics.
The production of seasonal vaccines, such as those for influenza, presents unique challenges to manufacturers due to the necessary time constraints resulting from annual strain selection. The timeline for development of a seasonal influenza vaccine...
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 ultimate goal of formulation development is a stable product. In the case of a protein product, that can be defined as delivering the correct dose, in the native secondary and tertiary...
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...
Download World Courier’s latest piece which shares the story of the changes in temperature-controlled transport and what these trends mean to your business. Explore industry demands and evolving...
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...