When it comes to agriculture, the people of Austria are among the most dead-set against so-called “genetically modified organisms” of any population in Europe (1). But as is so often the case elsewhere, their attitude toward biotechnology used in medicine is much more friendly. This may have to do with the country’s traditional strength in environmental biotech (ranging from wastewater treatment and organic waste composting to anaerobic digestion for biogas generation) and also food biotechnology. That is the suggestion of…
Tuesday, April 1, 2008 Daily Archives
Sharing Is What It’s All About
Recently in Washington, DC, two conferences were held on the topics of cell and gene therapy. The California Separation Science Society (CASSS, www.casss.org) hosted a Well-Characterized Biological Products (WCBP) Chemicals, Materials, and Controls (CMC) strategy forum on “Current Practices for Assessing the Comparability and Stability of Gene Therapy Products,” while blocks away, Phacilitate hosted the 2008 Cell and Gene Therapy forum. At the WCBP CMC strategy forum, participants heard the US FDA–CBER perspective on the importance of comparability studies for…
BioProcess International Analytical and Quality Summit
This event offers key strategic insights from industry leaders regarding assay qualification and validation optimization, improvement of the pace and quality of analytical results, and improvement of product quality through increased process understanding. It brings together three conference programs including The 4th Annual Analytical Method Validation, the 2nd Annual Biophysical Analysis for Bioprocessing, and IBC’s 5th Annual Process Quality Forum on Process Characterization and Control. Analytical Method Validation This event gives assay development and validation scientists a broad view of…
Products, Services, and Literature
Process Monitoring Product: SciLog conductivity, pressure, and temperature (pictured) sensors Applications: In-line single-use purification monitoring Features: Sensors come with embedded memory with stored IDs, serial numbers, lot numbers, calibration, and any calibration offsets. Products are cleanable with NaOH or sterilizable by autoclaving, ethylene oxide, or gamma irradiation. Sensors and monitors document parameter changes during processing and send them to a printer, programmable logic controller (PLC), or to a spreadsheet on a personal computer. They come in a variety of sizes…
Understanding Analytical Methods
As biosimilars move into the forefront of consciousness in the biopharmaceutical industry, analytical methods, especially comparability studies, have an increasingly important role to play. Additionally, as more products progress from phase 1 to 2–3 studies and require production-scale manufacturing, analytical methods are an important component of technology transfer or in-house scale-up efforts. The Analytical Methods for Biologics track will elucidate these challenges, and will include discussions about the latest changes in immunogenicity guidance, posttranslational modifications, analytical strategies, comparability testing, and…
Moving On in Cell Culture
Record-breaking titer outputs in mammalian cell culture systems in the past few years have pushed the industry to a new crisis of sorts: resolving the downstream bottleneck. However, the cell culture and fermentation groups at biopharmaceutical companies aren’t yet ready to sit back and rest on their laurels. Instead, they are moving forward, tackling the downstream issue with upstream modifications and continuing their drive for more cost-efficient processing. The Cell Culture and Upstream Processing track will focus on cell culture…
Anything But Chromatography?
In 2006 a new term was coined that is now all too familiar in the industry: downstream bottleneck. With observations of a slow cycle of downstream process improvements indicating potential solutions in the next five years, downstream processing is a very hot topic at conferences and in publications. Thus, the Recovery and Purification track will be highly focused on this pertinent and timely issue. Beyond discussing the bottleneck itself head-on in the opening sessions, the track will focus on alternatives…
In the Therapeutics Zone
Small molecules are still not providing cures for many diseases, and this is why biological therapies continue to be developed. They often offer greater convenience to patients, as well as longer lasting therapies,” says William Prather, MD, senior vice president of corporate development at the Israeli stem cell company, Pluristem. The therapeutics area at this year’s BIO International Convention will play host to many interesting technologies for producing and improving protein therapeutics, vaccines, and stem cells. Protein Therapies Remain Top…
Tackling Formulation and Delivery
The final hurdle in getting a product to market is the formulation and fill–finish step in process development. By their nature, protein therapeutics are more fragile and require a great deal of work to achieve product stability in final formulations. A cell line can be highly productive and efficient in protein production, but if you can’t stabilize the resulting protein and deliver it to patients intact, that’s a costly and useless exercise. The Formulation and Drug Delivery track of the…
In the Laboratory Automation Zone
When you hear the phrase “laboratory analysis” on a TV commercial, maybe you imagine a technician in a white coat and safety goggles pouring a chemical from one test tube to another. Technicians still wear white coats and goggles, but today, in many labs, they’re not the ones pouring the chemicals. Instead, tiny trays carrying minuscule dabs of samples are whisked by robots from one analytical workstation to another. The workstations are equipped with ultraprecise instrument systems to prepare the…