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…
April 2008
“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…
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 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…
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,…
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…
Cell Cultivation Process Transfer and Scale-Up
Discovery, development, and commercialization of novel biologics frequently involve collaboration between two or more companies. In the context of these business relationships, transfer of technology from one institution to another is a crucial step that needs to be executed flawlessly and rapidly. Follow-up activities usually include the development of productive, reliable, and scalable processes and are equally important because they are usually on the critical path to market. PRODUCT FOCUS: MONOCLONAL ANTIBODIESPROCESS FOCUS: TECHNOLOGY TRANSFER (PRODUCTION) AND ANALYTICAL METHODS DEVELOPMENTWHO…
In the Clinical Trials Zone
A new product takes a long and winding road from a laboratory to the patients it is designed to help. Many factors and organizations affect just how many months and dollars it will take to shepherd a new product from preclinical studies to market. Carefully documented, regulatory-compliant clinical trials are key to marketing approval. Clinical trials involve a choreographed network of regulatory agencies, sponsor companies, and clinical investigators. Myriad specialists in that network include those who produce and deliver an…
Current Status of Protein Quantification Technologies
With the help of rapid advancements in molecular biology and genetic engineering, a rising number of biotherapeutics are being developed and marketed. The quality and safety requirements for this class of active ingredients has steadily increased over the decades since Eli Lilly put forth the first insulin manufactured using genetically modified organisms in 1982. This has led to dynamic developments in protein analysis and proteomics intended to meet a growing demand for new technologies and sophisticated analytical techniques to characterize…
In the Drug Delivery Zone
A rule of thumb in drug development states that the larger a therapeutic molecule is, the more trouble it will be to make, ship/store, and administer to patients. Biotherapeutics include proteins (such as antibodies), vaccines, some smaller peptides (such as hormones), DNA for gene-transfer therapies, cells and tissues, and to a lesser extent blood-fractionation products, allergenics, and RNA/oligonucleotides. Biomolecules are big and unwieldy, they’re produced in complex mixtures by biological processes, and they face numerous challenges in storage and within…