Recent achievements driven by the application of novel approaches and tools have caused significant savings in time and money for cell-line selection and development. This conference will report on the latest applications of automated tools, “-omics” technologies, analytical methods, and engineering strategies to help you understand and improve the stability, quality, and workability of your cell lines. Hear the latest case studies and unpublished data from industry and academia, and collaborate with your peers during strategic discussion groups and interactive…
Author Archives: BPI Contributor
Global Marketplace
Biobanking Resource Product: CryoFeed microsite Applications: Cell and tissue banking Features: Wheaton offers a curated collection of information about preserving cryogenic biospecimens online. The company responded to an influx of questions about sample containment by creating the CryoFeed website. It provides biobanking-related news and technical tips as well as a place where users can discuss related issues. As samples are collected and cryogenically stored at hospitals, universities, research institutions, and pharmaceutical companies, Wheaton says interest in biobanking and long-term storage…
IBC’s 22nd International Intensive Symposium Biological Assay Development, Validation, and Maintenance
Plan now to attend this highly technical conference for just the right mixture of practical tools, regulatory trend overviews, emerging technologies, and product case studies. Bioassay scientists are intensifying their use of new technologies. Quality by design validations are becoming common, with statistical tools implemented during development, and cells are being developed for single-use applications. This is the must-attend event for bioassay professionals who want to keep up with these changes — where scientists gather to discuss how to overcome…
Global Marketplace
Biosensing Product: SpectroSens optical microchips Applications: Environmental monitoring and antibody detection Features: By using light to measure change, optical biosensors from Stratophase bring precision, flexibility, and cost-effectiveness to real-time monitoring and diagnostics. The SpectroSens microchip biodetector is coated with specific antibodies that bind with high specificity and affinity to biological targets. When a given toxin, bacteria, antibody, or virus is present in a sample, it binds and triggers a positive detection. One disposable microchip can be used to test multiple…
TIDES Oligonucleotide and Peptide Research, Technology, and Product Development
More therapeutic candidates are nearing approval, and the many classes of oligonucleotide therapeutics in development are creating great excitement. The peptide pipeline is vital, with candidates that could be blockbusters. To tap into this market and get the best information to move your program forward, there is no better place to meet than at TIDES. Manufacturers face tremendous pressure to keep drug costs down with uncertainty about regulatory expectations for analytics and GMP manufacturing issues. The industry needs to know…
Sustainabilty Is Good for Business
James Cerruti is senior partner of strategy and research for Brandlogic, a full-service brand consultancy that published in June its 2011 Sustainability Leadership Report: Measuring Perception vs. Reality in partnership with CRD Analytics. The report measured actual and perceived performance of environmental, social, and governance (ESG) factors for 100 major corporations. The report is based on a survey of key audiences who are considered to be “highly attentive” to ESG issues: investment professionals, purchasing and supply chain managers, and graduating…
Production of CGMP-Grade Lentiviral Vectors
Lentiviral vectors are important tools for gene transfer because of their ability to transduce a number of cell types without the need for host cells to be dividing. As a result, investigators are using them as gene delivery vehicles in clinical applications. Since lentiviral vectors play such a vital role in gene therapy, they need to be manufactured at large scale for clinical trials. But, large-scale production using CGMP methods can present a number of challenges.
To address these challenges, the authors of this case study developed a process that allows for extensive scale-up in a safe, sterile, and reproducible system to produce clinical-grade lentivirus. This manufacturing process is very efficient and can be carried out using minimal staff (two operators for production of each subbatch). It provides the extensive scale-up capacity necessary to produce CGMP-grade lentivirus, and it has been used successfully in several completed and on-going phase 1–2 ex-vivo gene therapy clinical trials.
Global Marketplace
Disposable Bioreactor Product: UniVessel SU controller Applications: R&D and process laboratory-scale cell culture Features: UniVessel SU bioreactors work with most Sartorius Stedim BIOSTAT benchtop controllers as well as those for conventional, stirred-tank glass bioreactors. The system includes disposable SENSOLUX sensor patches for optical noninvasive pH and dissolved oxygen (DO) measurement. It is applicable to small-scale protein expression, media, and process optimization studies. Contact Sartorius Stedim Biotech SA www.sartorius-stedim.com GMP-Grade Nutrient Product: CGMP-grade hyaluronic acid Applications: Cell culture, drug delivery, and…
Innovation Is One Key to Economic Future Success
Following up on its 28 June 2011 innovation forum, the Hamilton Project (an economic policy initiative of the Brookings Institution, www.hamiltonproject.org) created a new document detailing A Dozen Economic Facts About Innovation for the United States. Drawing from insightful comments by panelists during the event, authors Michael Greenstone and Adam Looney focused on three specific points: Innovation has historically improved the US standard of living through higher wages, lower prices, and health advancements. The pace of innovation has…
Americans Say Yes to Stem Cell Research
University of Nevada, Reno, researchers reported in Nature Biotechnology this past summer on their survey of >2,000 Americans about stem cells and other controversial research topics. Supporters of using embryonic stem cells in disease research outnumbered opponents five to one. Most respondents (>66%) also approved of induced pluripotent stem cell treatments. But opponents of stem-cell–based cosmetic treatments outnumbered supporters by almost two to one.