April 2008

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…

In the Information Technology Zone

Successfully driving your global business requires vigorous, secure information exchange within your facility, from site-to-site, and with your partners and contract service providers. Tools to capture data in real time support decision making and enable companies to manage volumes of historical data needed for regulatory submissions. Software is available for data mining, managing clinical trial networks, and assessing toxicology data (among many other things). Information technologies in the biotechnology industry facilitate development and delivery of new therapies and diagnostics, improvements…

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…

Development of an Antibody Screening Assay for Selection of Production Cell Lines

Biopharmaceuticals such as recombinant monoclonal antibodies (MAbs) account for a significant proportion of all new drugs (1,2,3). Although manufacturing site capacities have expanded and process efficiencies have improved greatly, there is still some concern the current biomanufacturing capacity worldwide might not meet increasing market demands (1, 2). PRODUCT FOCUS: RECOMBINANT PROTEINSPROCESS FOCUS: PRODUCTION PROCESS DEVELOPMENTWHO SHOULD READ: QA/QC, PROCESS DEVELOPMENT, AND ANALYTICAL PERSONNELKEYWORDS: CELL LINE DEVELOPMENT, SCREENING ASSAY, MONOCLONAL ANTIBODIES, FC PROTEINS, CHO, IGG, HTRF, ANTIBODY TITER, CELL LINE PRODUCTIVITY,…

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…

In the Bioprocess Zone

Since the turn of the century, industry analysts have touted the “coming of age” of the biotech industry — and they’re inevitably talking about biopharmaceuticals. In fact, biotech has become the innovation engine for the pharmaceutical industry as a whole. Advances in genomics, proteomics, and other biotech research are bringing about not only new drug molecules, but also whole new therapeutic classes such as gene and cell therapies. Biotherapeutics represent the fastest-growing segment of the pharmaceutical industry, with more than…

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…

Management Engagement Is Key to Successful Quality Systems

Many models are available for establishing a quality system in regulated industry, whether for pharmaceuticals, medical devices, or biologics. Each company establishes a set of standard operating procedures (SOPs) that enables it to manage operations and then implements a quality system around its product and process. But why do some quality systems work well, whereas others falter or fail miserably? Does the fault lie in procedures, implementation, or maybe training? Perhaps the answer can be found by examining the involvement…

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…

“In the Zone” at the BIO International Convention

We invite you to the 2008 BIO International Convention, Tuesday–Friday, 17–20 June 2008. Biotechnology innovations are addressing the world’s challenges to heal, fuel, and feed growing and changing populations. Our event cochairs (Catherine Mackey, PhD, senior vice president of Pfizer in La Jolla, CA, and Greg Lucier, chairman and CEO of Invitrogen Corporation in Carlsbad, CA) have focused the 2008 event theme and program to highlight this important role of biotechnology: Innovate. Heal the World. Fuel the World. Feed the…