Use of automated liquid handling equipment for rapid testing and reproducible screening of thousands of molecules, cells, and compounds has become an essential component of life-science laboratories across the globe. Along with an increase in such use, transferred volumes have shrunk, as demands increase on transfer accuracy and precision when aspirating, diluting, dispensing, mixing, and washing. Automated liquid handlers are generally used to increase the productivity and repeatability of volume transfer, but as discussed here, they are still prone to…
June 2009
A Presanitized, Purpose-Designed, Single-Use TFF Strategy
For many years, biopharmaceutical manufacturers have worked to increase capacity, address upstream production issues, and improve product yields. Notable successes recently achieved in upstream technology have significantly increased expression rates and therefore, upstream production capacities. Successes in generating higher titers combined with increasingly stringent quality and regulatory requirements have led to a number of challenges in aligning the efficiency of downstream processing with upstream titers. It is generally recognized that downstream processing costs account for about 70% of…
Applying Intelligent Flow Microscopy to Biotechnology
Ongoing requirements for additional insight and CGMP-compliant measurement have led to interest in new technologies that can be applied to the analysis of many different types of particle-containing fluids. Micro-Flow imaging (MFI) is a robust, versatile, and intelligent vision technology that is increasingly used for evaluating populations of microparticles encountered during bioformulation development (1). It is also being accepted in fill–finish processes and many other biotechnology applications. Features of MFI technology that have contributed to its rising popularity include the…
BioProcess International Conference and Exhibition
IBC’s BioProcess International Conference and Exhibition (BPI) will head back to the US east coast for 2009 to Raleigh, NC. This has become the largest, most respected forum focusing on technical, regulatory, and strategic planning challenges in the manufacture of biotherapeutics. Four comprehensive conference tracks as well as intimate workshops, strategic discussion groups, training seminars, and colocated conferences will continue to provide you with an interactive and lively format all in one location. BPI allows you to meet face-to-face with…
Global Marketplace
Custom DNA Product: McBox luc minicircle and plasmid DNA Applications: Transfection optimization Features: The McBox luc kit includes 100 µg each of certified minicircle and plasmid DNA, both including the firefly luciferase reporter gene. A vial with endotoxin-free water for injection ensures high quality after dilution. Scientists can now directly compare minicircle DNA with a corresponding “classical” plasmid in individual applications. Minicircle DNA contains almost exclusively the gene of interest and its regulating sequence motifs. This provides a safe and…
New Validation Guidance Causes a Stir
In November 2008 the US FDA finally issued a new draft guidance on process validation (1). The original guidance on this topic was published in May 1987, and the FDA explained that “since then, we have obtained additional experience through our regulatory oversight that allows us to update our recommendations to industry on this topic.” The new guidance is intended to reflect some goals of the FDA’s Pharmaceutical GMPs for the 21st Century, an initiative that was finalized in 2004.…