March 2008

Throwing a Flag at Biosimilars

PHOTO COURTESY OF ROGER LUNDBLAD (PICTURED). When I officiated at high school (US) football, I learned a lot from the experience. Contrary to popular opinion, there are rule books referees study. However, although the rule book is modest in size, the case book for interpretations is large. This brings me to the topic of generic or follow-on biologicals and biosimilar products for which there will be rules, and the interpretations will be many. Continuing with the US football analogy, the…

IP Strategies to Combat Distribution of Counterfeit Drugs

Counterfeit products are no longer restricted to Gucci purses and Rolex watches. The pharmaceutical business has seen an alarming rise in the number of counterfeit products entering traditional distribution and supply chains. As a result, consumers can unknowingly purchase counterfeit pharmaceuticals from their local pharmacy and receive little or no therapeutic benefit, or worse, die as a result of ingesting counterfeit products. Pharmaceuticals are subject to counterfeiting in a number of ways. A counterfeit product may contain no active ingredient…

Biological Assay Development and Validation

IBC’s 16th annual Bioassay Conference is the meeting for learning about developing, qualifying, validating, and maintaining important biological assays. Come and discover the newest techniques for streamlining development and validation using easy-to-understand statistical approaches. Hear how other assay developers are accelerating their development plans and meeting aggressive timelines. Learn about use of the newest technology and regulatory trends to develop the right assay, at the right time, in the quickest possible way. After attending this conference, you will catapult your…

Products, Services, and Literature

Downstream Processing Product: SciPure 300 GMP production platform Applications: Tangential-flow filtration (TFF) Features: Revolutionary purification platform automates, documents, and analyzes any TFF application needed in a GMP environment. The user-friendly interface is built on the familiar Windows XP operating system and .NET framework; administrative users have easy access to and control over all process parameters, users, permissions, and recipes. The system logs all program variables and automatically maintains optimal TFF conditions through continuous data acquisition and precision control loops. Contact…

“Hitchhiker’s Guide” to Bioprocess Design

Acceptance criteria Numerical limits, ranges, or other suitable measures for acceptance of results from analytical procedures that a drug substance, drug product, or materials at other stages of their manufacture should meet (1). Numerical limits, ranges, process signatures, or other suitable measures that are necessary for making a decision to accept or reject the result of a process, in-process variable, a product, or any other convenient subgroups of manufactured units (2). Numerical limits, ranges, or other suitable measures for acceptance…

Taking the Next Step

Long-term hopes for stem cells to cure various diseases are nourished by the latest developments in stem cell research. First clinical studies have begun (Thera Vitae, Israel: congestive heart insufficiency), and patents have been filed (Stem Cell Therapeutics, Canada: combined regulation for the production of neural cells). Clinical use depends on technological requirements for a reproducible cultivation and controlled differentiation of cells in sufficient numbers, so more and more researchers are focusing on the scale-up of stem cell production. For…

Near-Infrared Spectroscopy for Rapid, Simultaneous Monitoring

The use of cellular physiology to make target molecules has been practiced for centuries, with early examples being the production of wine and beer through yeast fermentation. Single (e.g., bacteria and yeast) and multicellular (plant or animal) organisms can be harnessed to produce otherwise chemically complex, low-yield, or chemically uncharacterized materials. These include “lock-and-key” receptor complexes with perfect stereochemical specificity, large-scale protein scaffolds, or antibiotics. One example is penicillin, with a sensitive β-lactam ring structure at its core (1). Mass-production…

Automated Closed-Loop Solution for Bioreactors and Fermentors

Today, there is much discussion regarding the promise of improved insight into bioprocess industry processes. Look to the pages of industry publications such as this one, and you’ll see that industry leaders in process measurement and control have begun to discuss openly the potential for simulating and modeling bioprocesses. “Important opportunities such as the application of mass spectrometers, dissolved carbon dioxide probes, and inferential measurements of metabolic processes have come to fruition today opening the door to more advanced process…

Carbohydrates and Their Analysis, Part Two

A polysaccharide is a complex glycan with at least 10 monosaccharide units. It can be formed by the multiples of the same monosaccharide (a homopolysaccharide) or by two or more monosaccharides combined (heteropolysaccharide). Two homopolysaccharides can have completely different conformations — and thus properties — based on the position and type of glycosidic linkages in the structure (Figure 9). Polyglucose ranges from cellulose — β(1,2,3,4) glucan, with its zig-zag chains regularly superimposed to each other and bound tightly by hundreds…

PAT Tools for Accelerated Process Development and Improvement

Broadley-James Corporation, Emerson Process Management, and the University of Texas at Austin are working together to examine and quantify the potential for faster optimization of batch operating points, process design, and cycle times. We’re also looking for more reproducible and predictable batch endpoints. The objective of this effort is to show that the impact of PAT can be maximized through the integration of dynamic simulation and multivariate analytics in a laboratory-optimized control system during product development. Data from bench-top and…