Volume 9, Issue 1
2010

Cover image: Structure of Adenovirus Type 5 derived from cryo transmission electron microscopy. See http://tinyurl.com/2a4p73h for visualization. Image courtesy of NanoImaging Services, Inc.

Optimizing Clarification and Concentration Steps Using an Automated Process System and Design of Experiments (DoE)
By Timothy L. Bowen, Catherine Blake, Deborah R. Cohen, and Kieron Walsh

Process optimization is a key development step that precedes scale-up and tech-transfer in a manufacturing environment. New England Biolabs (NEB) and GE Healthcare (GEHC) set the objective of improving filtration clarification and concentration process steps with the target of improving overall efficiency, and reducing the labor time and expense associated with these unit operations...

Improving Process Economics When Developing a Vaccine Portfolio
By Philip Ball and David Simpson

Over the last few years, the challenges of vaccine development have created perhaps an unprecedented level of scrutiny, not just within the biotech industry, but also in the consciousness of the general public. This was certainly the case during the recent H1N1 influenza outbreak. The demand to know when a vaccine would be available, and if producers could meet the global demands consistently made front page news. The challenge of rapid and scalable manufacture is of course nothing new in biopharmaceutical development and in many respects, monoclonal antibodies are leading the way as the industry moves towards the required level of industrialization...

Novel Automated Micro-Scale Bioreactor Technology: A Qualitative and Quantitative Mimic for Early Process Development
By Gareth Lewis, Richard Lugg, Ken Lee, and Richard Wales

With increasing time pressures to move biological therapeutics into the clinic, bioprocessing development studies have to be limited. Currently, core studies typically involve the use of shake flasks and benchtop bioreactors to select the most productive clones, optimum media, and bioprocessing conditions. The capacity for using benchtop bioreactors is especially limited as it is resource-intensive and has high capital equipment and infrastructure costs. Consequently, scientists frequently cannot perform full design-of-experiments (DoE) and are generally only able to take one or two of their most promising clones forward for partial DoE runs in benchtop bioreactors...

Quality Risk Management Application Review in Pharmaceutical and Biopharmaceutical Industries
By Lorely Milá Cáceres et al.

An interesting situation occurred ten years ago in an industry where quality had been the critical factor in management decision-making. Quality was abruptly bumped to second place behind pricing, which started a global rush to find lower-cost suppliers and eventually resulted in massive outsourcing. During this evolution, the importance of quality systems for the pharmaceutical and biopharmaceutical community was recognized by regulatory agencies that began establishing risk management standards...

Hydrolytic Enzyme Production by Aspergillus niger in Solid State Fermentation: Stimulation of Transcriptional Regulation Through Carbon and Nitrogen Supplementation
By Shauna M. McKelvey and Richard A. Murphy

Filamentous fungi are an important class of organisms with significant commercial importance in the biotechnology sector. Those that dominate the markets and are deemed the most important include: Aspergillus, Penicillium, and Trichoderma. They have become indispensable for the production of enzymes due to their exceptionally high capacity to express and secrete proteins. In addition, recent advancements in genomics have allowed for the sequencing or partial sequencing of many of these species. The significance of these fungi and their associated enzymes has accelerated interest in understanding the mechanisms involved in the regulation of gene expression, primarily through the characterisation of the transcriptional elements involved...

Storage and Transportation of Biological Materials: The Importance of a Sample Management Plan
By Lori A. Ball

Biological samples such as human tissue, cell lines, and serum specimens are a direct source of molecular data that can be used to identify targets for disease therapy, detection, and prevention. However, the validity and reliability of data derived from burgeoning analytical technology is highly dependent upon properly preserved, well-annotated biospecimens. As a result, biopreservation and biobanking have become an increasingly integral component in advancing today’s biotherapeutic development...

The Effects of Temperature Variation in the Bioethanol Production Process
By K.L. Tiwari, S.K. Jadhav, and S. Tiwari

Fermentation utilizes organic substrates and organic electron acceptors to produce reduced organic substances as end-products. Bioethanol has a number of advantages over conventional fuels because it is produced from renewable resources. Ethanol is a high octane fuel that can replace lead as an octane enhancer in petrol by helping to oxygenate the fuel mixture so it burns more completely and reduces polluting emissions. The burning of ethanol more closely represents a natural carbon dioxide cycle since the released CO₂ is recycled back into plants where the carbon dioxide becomes the carbon source for new sugars, starches and cellulose...

Found Money: Tax Credits and Incentives Can Offset Research Costs
By Daniel Lewicki, Walter Marvin, and David Ji

How much new business does it take to add $100,000 or even $1 million to the bottom line? Even with tax deadlines looming for companies that filed extensions, there is still time to maximize the benefits of all available tax credits and incentives. A powerful tax incentive known as the research and development (R&D) tax credit is available in the United States at both the federal and state levels to help manufacturers recover a significant amount of R&D costs...