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…
2012
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…
From the Editor
This issue marks the beginning of BPI’s tenth volume of publication. We debated how and when to launch our tenth-anniversary year: Issue 1(1) was published in January 2003, but the magazine was actually “born” in mid-2002 with its adoption by Informa. We founding editors had six months in our 400-ft2 Eugene, OR, office to build an acquisitions database, create a manuscript pipeline, and design the magazine’s first templates. (A radical idea: BPI was designed by editors, who still create all…
Ten Years of Upstream Production
Disposables: Single-use technology has arguably been the biggest “story” of the past 10 years in bioprocessing. And for many people, implementation of disposable elements began soon after the turn of the century with a Wave bioreactor (1,2), first developed by Wave Biotech in 1996, now a mainstay of many an upstream process development laboratory and sold by GE Healthcare. BPI identified the significance of such technologies early on, making them the subject of a supplement in its second year. By…
Manufacturing Process Automation
When you think of futuristic manufacturing facilities and processes, robots might come to mind in a science fiction setting where humans are absent and production lines are directed by computerized drones that perform tasks we can’t even imagine today. As the pace of technology shuttles us swiftly into the real future, however, life-science manufacturers need to pause to examine the purpose of automation and how we can best steer its course. In bioprocess manufacturing and other industries, technology is growing…
Development of a Plant-Made Pharmaceutical Production Platform
Since the late 1980s, studies have shown that plants can manufacture functional transgenic pharmaceutical compounds. Advantages attributed to plant-made pharmaceutical (PMP) approaches are compelling, and PMP production continues to attract interest from investors and the biopharmaceutical industry (Table 1). Proposed PMP benefits include proven scalability, high production capacity, limited exposure to human or animal pathogens, lower capital expenditures (CapEx), and decreased operating costs. Those putative advantages have proven to be significant business forces driving continued investor support for PMP ventures.…
Recommendations for Cell Banks Used in GXP Assays
Cells and cell-derived reagents form the basis of an operationally challenging class of test methods used in execution of product potency testing (stability and lot release), assessments of pharmacokinetic/ pharmacodynamic (PK/PD) profiles, detection of antidrug antibodies (ADAs) or neutralizing antibodies (NAB), and characterization and comparability testing of biopharmaceutical products. Frequently, cell-based assays provide the only measurement of the tertiary/quaternary structure of each batch of product at the time of lot release and during stability testing to assist in determining product…
Metabolic Process Engineering
Metabolic process engineering (MPE) was developed at Bristol-Myers Squibb Company as a tool to effectively control and optimize industrial cell culture processes used for production of biological drugs. A fundamental need was identified to introduce manipulations to the metabolism of production cell lines without genetic engineering. Optimization goals for production cell line performance include, for example, volumetric productivity, control of product quality attributes and by-product formation, and improved process scalability. With MPE, we could achieve targeted changes to cellular metabolism…
Noninvasive Optical Sensor Technology in Shake Flasks
In process development, appropriate scaling is important to achieve acceptable product quality without compromising titer (1). Scale-down approaches involve matching the oxygen transfer coefficient (kLa) value, impeller tip speed, power per unit volume, or mixing time to those of a bioreactor (2). Bench-top bioreactors are typically used in bioprocess engineering as scale-down models of commercial units in fermentation and cell culture because of their similarity in geometry (H/D ratio) and mechanical properties (agitation type and sparging). By contrast, shaking culture…
Rapid Production of Functional Proteins of a Combinatorial IgG Library in CHO Cells
Recombinant DNA (rDNA) technologies provide a wide range of tools for producing a broad array of recombinant proteins. Since the early 1970s, the biotechnology industry has harnessed those tools — together with genetic engineering and genomics — for developing new classes of innovative and effective therapeutic molecules. The therapeutic recombinant protein market segment now represents the core of the medical biotechnology industry, with hundreds of companies involved in discovery, development, and marketing. Although recombinant technologies are extremely powerful tools, significant…