By Kathryn Martin Remington, Ph.D., Principal Scientist for Clearance Services, BioReliance
Chromatography steps are typically the backbone of the purification process for a biopharmaceutical product, and are usually included in the evaluation of the viral reduction capacity of a manufacturing process. In viral clearance studies of chromatography steps, the capacity of the chromatography resin to provide physical separation of the spiked virus from the product fraction is determined. Viral reduction by chromatography steps is considered less robust than by other less complex steps, such as inactivation steps. This is because chromatography can be more difficult to accurately scale down, and also because a number of operating parameters may influence the viral reduction that is achieved.
By Mark A Collins Ph.D., BioFortis, Inc.
In this white paper we review the key drivers impacting "traditional" biobanking and detail the challenges such biobanks face in delivering new biomarker-based research. To facilitate the discussion of approaches to overcoming these challenges we introduce the concept of Next Generation Biobanking, and define the attributes an "ideal" Next Generation Biobank would need to drive effective biomarker-based research. Finally, we demonstrate the benefits of adopting a Next Generation Biobanking approach, with a case study in cancer biomarker discovery.
By Dr. Frank Westad, Chief Scientific Officer, CAMO Software
Multivariate statistical process monitoring (MSPM) has been established as a valuable tool for ensuring reliable product quality in the process industry. However, many organizations today are still not fully utilizing its potential to make significant improvements in their production environment.
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.
By Jason Heberle, CTP, Cold Chain Development Engineer, Cryopak, Inc
One of the most continuously undefined, yet singularly utmost important, variables of temperature-controlled shipping is the actual ambient temperature that will be found en route.
This article covers improving compliance and efficiency in the pharmaceutical supply chain with reduced cost and risk. How does the sponsor ensure that product transfer conforms to the same established written procedures demanded at the investigator level throughout the full length of the supply chain? Or, more specifically, while in the hands of nonpharmaceutical, noninvestigator personnel?
The IBC Well Characterized Biologicals conference, taking place October 21 to 23, 2013 in Washington DC, is the leading industry conference to provide multiple, detailed case studies of the challenges, strategies, and technologies involved in characterization and comparability of new biological molecules. Readers save 20 percent off the standard rate* when you mention code B13193BIO during registration. Download the brochure at http://bit.ly/18WTlgW.
*New registrations only