By Rob Wright
During the ill-fated 1970 Apollo 13 mission to the moon, it was astronaut Jack Swigert who alerted ground control that something had gone terribly wrong when he uttered the phrase, "Houston, we've had a problem here." Those same words seem very fitting to the current state of affairs regarding the skyrocketing costs of drug discovery. Recent estimates place the expense of successfully bringing just one drug to market at between $350 million and $1.2 billion. However, in the past decade, companies having brought four to 13 drugs to market have watched the price tag reach stratospheric heights — orbiting $5 billion+. "I think the pain point has reached a threshold that's no longer bearable," states Dalvir Gill, Ph.D., CEO of TransCelerate BioPharma.
By Xuemei M. He, Sherif Hanala, and Mark Snyder, Bio-Rad Laboratories, Inc.
Mixed-mode chromatography has become an important purification tool for downstream process developers. Under specific purification conditions one or more such interaction modes may be involved in the binding or repulsion between the target protein and the chromatography media. Therefore, the behavior of a protein during purification by mixed-mode chromatography is often not predictable on the basis of its pI or amino acid sequence.
As the pharmaceutical industry pipeline continues to shift from traditional small molecule-based drugs to a new class of biologic therapeutics, bioresearchers need powerful bioanalytical techniques for the in-depth characterization of the protein of interest required at each development stage.
By Ryan Mauro, Validations Sales Specialist, Sartorius Stedim Biotech
Process validation is the collection and evaluation of data throughout the manufacturing process, which establishes, scientifically, that there is consistency of quality, reproducibility, and traceability from batch to batch.
By Kathrin Schmale, Strategic Marketing Manager, DASGIP; and Karl Rix, CEO, DASGIP BioTools, LLC
Advanced benchtop bioreactors can harmonize unit operations between development and production while supporting the aims of quality by design.
By Reynaldo Roman for Marken
On December 21, 2012, the U.S. Fish and Wildlife Service (FWS) finally addressed an issue that has been of significant debate among importers of Chinese hamster ovary (CHO) cell specimens and trade experts. FWS informed the trade community that only shipments of actual CHO "cell," "cell cultures," and "cell lines" are regulated by the agency and require an import/export license for trade.
By Staffan Ingfors, Head of Global Service Network, Envirotainer
With more than 50 unit load device (ULD) handling locations worldwide, Envirotainer operates the world's largest independent network of ULD ground handling and repair services.
By Michael Boetzkes, Quality Manager, Vaisala Canada Inc. Life Science Division
Any good quality manager knows that assumptions about an instrument can lead to unpleasant surprises during the calibration cycle. Test and measurement equipment play a critical role in most production and development processes. These instruments are used to make decisions regarding the effectiveness of processes and to ensure product quality.