The Biologics Price Competition and Innovation (BPCI) Act of 2009 establishes an abbreviated approval pathway for biologic drugs in the United States that are demonstrated to be highly similar (biosimilar) to or interchangeable with biological products licensed by the US Food and Drug Administration (FDA). BPCI was part of the Patient Protection and Affordable Care Act (Act) that was signed into law on 23 March 2010 (1). As the name of the umbrella legislation implies, the legislative…
2011
Development of a Universal Influenza Vaccine
Seasonal influenza affects millions of people around the world, with as many as 500,000 deaths annually resulting from influenza-related illnesses. The flu virus undergoes frequent and unpredictable mutations (antigenic drift and shift) that limit the ability of available strain-specific vaccines to protect the population against strains other than those specifically included in a particular season’s flue vaccine. Annual reformulation of the vaccines is needed for annual immunizations. BiondVax Pharmaceuticals Ltd., an Israeli biotechnology company, is developing a universal…
Key Aspects of Enzyme Activity and Steady-State Kinetics
Living systems rely on enzymes to perform many essential functions for survival. One prime example is digestion, the conversion of food into energy. Each enzyme possesses specific requirements for the types of molecules that it can use as substrates or reactants to convert to products. Here, I provide some basic information about enzymes, explain their biochemical parameters (e.g., kinetic parameters) and significance for characterization, and review related assays currently available to the bioprocess industry. Lactose intolerance is a common enzyme…
Comparing H1N1 Virus Quantification with a Unique Flow Cytometer and Quantitative PCR
A novel influenza A (H1N1) virus was discovered in Mexico in early 2009 (1). Infections from this strain led to declaration of a pandemic midyear, with about 61 million patients and 13,000 deaths reported by the US Centers for Disease Control (2). Although the pandemic officially ended in August 2010 (3), vaccines are still in demand to protect people against the H1N1 strain that is now expected to circulate seasonally for years to come. To best respond to…
Meeting Increased Demands on Cell-Based Processes By Using Defined Media Supplements
Rapidly increasing demand for cell-derived products has placed huge pressures on the biomanufacturing industry’s production capacity requirements. Media development strategies continue to be a primary focus for optimizing output from cell culture systems. Animal cells used in manufacturing protein products have complex nutrient requirements specific for each cell type, clone, and product. Individual nutrient requirements were once addressed by using serum-based media rich in growth factors and supplements, which provided an optimal culture environment for cell growth and productivity (1).…
An Approach to Design and Performance Testing of an Impeller-Driven Single-Use Mixer
Single-use technology is now well established for many bioprocessing unit operations, including sterile filtration and product storage, where it provides specific benefits such as elimination of cleaning and cleaning validation, reduced risk of contamination, and enclosed systems for safer handling. Recently, single-use technology has been introduced into more complex unit operations such as purification by chromatography (1), tangential-flow filtration (2), and mixing systems. More complex processing steps, however, present a challenging task for developers of single-use products. Mixing…
Localized Surface Plasmon Resonance for Bioprocess Development, Monitoring, and Validation
Academic laboratories have embraced localized surface plasmon resonance (LSPR) as the “new wave†of label-free technology (1). This technique is based on the ability of colloidal metal nanoparticles or nanostructured metallic films to absorb light in a narrow wavelength range. Metal nanostructures “sense†changes occurring at their surfaces by shifting the frequency of the light they absorb or reflect. As a consequence, a basic LSPR system requires only optical fibers, a source of white light, and a detector…
Global Marketplace
Resin Information Literature: Toyopearl info in French Applications: Purification of proteins, peptides, and oligonucleotides Features: Tosoh Bioscience introduces a new website and brochure featuring the Toyopearl resin portfolio for French-speaking scientists. The website overviews materials of construction and provides links to company information. The brochure covers all aspects of biochromatography for method development and larger-scale applications: size-exclusion chromatography (SEC), ion-exchange chromatography (IEC), hydrophobic interaction chromatography (HIC), and affinity chromatography (AFC) including protein A. Small prepacked Toyoscreen columns for rapid method…
Exchanging Real-World Solutions to Improve Speed, Cost, and Predictability BioProcess International Conference & Exhibition
The BioProcess International Conference is your one-stop industry resource for driving down costs; improving quality; and achieving rapid, robust, and resilient process development and manufacturing. This is where challenges are explored, solutions are uncovered, and opportunities are developed — at the largest and most highly respected event solely dedicated to biopharmaceutical manufacturing. New This Year New, unpublished data in every conference session Reports from the FDA, EMA, and leading industry players on biosimilars and biobetters Sessions on managing global manufacturing…
Expanding Emerging Market Access Through Regulatory Strategy
The growth potential for biopharmaceutical companies in emerging markets is no secret. By 2015, up to 35% of the global biopharmaceutical market will be in China and other developing countries. Yet even though most companies have reset their research and development (R&D) and supply chain models to support global expansion, their regulatory submission strategies and capabilities often fall short. The number of regulatory requirements has grown exponentially as biopharmaceutical companies enter new and disparate markets, but efforts in…