12 AUGUST ? After its fastest review yet for a cancer drug, FDA has approved the colorectal cancer drug Eloxatin (oxaliplatin).
Colorectal Cancer Drug Approved on 'Fast Track'—After its fastest review yet for a cancer drug, FDA has approved thecolorectal cancer drug Eloxatin (oxaliplatin). Used in combination withother cancer drugs, the drug was shown to shrink tumors in some patients anddelay resumed tumor growth.http://www.fda.gov/bbs/topics/NEWS/2002/NEW00825.html
The Solution Lies with SOLBIOTE™: Achieving Sustainability, a Growing Focus in Biopharma
October 28th 2024The nexus between biopharmaceuticals and sustainability is seemingly far apart, however, it is increasingly recognized as an inevitable challenge. It is encouraged to take a sustainable approach to reducing the environmental impact of the production and supply of medicines while improving people's health; delivering the well-being of people and the planet. Yosuke Shimojo (Technical Value Support Section Manager, Nagase Viita) will unveil how SOLBIOTE™, a portfolio of injectable-grade saccharide excipients, would be a key for the biopharmaceutical development and achieving sustainability for a better future of the industry.
Exploring New and Improved Analytical Methods for Traditional and Unique Modalities
December 12th 2024Biophysical characterization is critical to understand the make-up and behaviors of biologic therapies and vaccines, both early in development and throughout the manufacturing scale-up process. As biologics become more complex in structure, and as scientists improve their understanding of the effects of structure on stability, efficacy, safety, etc., there is a need to develop new and improved analytical methods to characterize biologic products. During this presentation, experts will discuss the latest challenges in biophysical characterization and will present solutions to overcome these challenges.
Leveraging Novel Analytical Approaches For Advanced Therapies
December 12th 2024The characterization and analysis of advanced therapies, such as cell and gene therapies (CGTs) can be difficult, as these products are designed to function using complex mechanisms of action (MOA)s. There are a wide range of challenges associated with accurately assessing the potency and impurity profiles of these complex biologicals. As many CGT programs qualify for accelerated review pathways, novel approaches for analysis and characterization can help generate data that allows for real-time decision making and faster development timelines. Catalent has developed a relative potency bioassay using quantitative polymerase chain reaction (qPCR) to assess relative transcription activity in cells treated with ligands or transgenic vectors. The assay platform can be used to qualify a repeatable, accurate, linear, and specific bioassay for assessing relative potency for CGTs, mRNA- and other nucleic acid-based therapies.