September 2011

From the Editor

      Conference themes and approaches can be looked at as sort of a crazy quilt representing the state of the industry: with pieces of all different shapes and colors that come together to form a cohesive whole. They fit together in many ways, depending on the organizers (quilters?); many pieces are omitted and saved for the next quilt. But how to find the most successful combinations requires technique as well as imagination. Here are some topics I’ve been…

Uniting Small Molecule and Biologic Drug Perspectives

    Cosponsored by CASSS (an international separation science society) and the US Food and Drug Administration (FDA), the January 2010 CMC Strategy Forum explored antibody–drug conjugates (ADCs), which are monoclonal antibodies (MAbs) coupled to cytotoxic agents. The ADC platform of products is being used more and more for clinical evaluation in oncology. More than a dozen companies are developing several types, including products conjugated with calicheamicin, auristatins, and maytansinoids. Such products use the specificity of a MAb to deliver…

Implementation of the ASTM Standard for Manufacturing Systems Verification

In 2007, ASTM International (ASTM), formerly known as the American Society for Testing and Materials, published its “E2500-07” international industry consensus standard for conducting a risk-based design and qualification of good manufacturing practice (GMP) manufacturing systems (1). This guide incorporates risk- and science-based practices to focus on critical aspects affecting equipment systems throughout their design–qualification–operation lifecycle. Presentations at recent PDA and ISPE annual meetings indicate that the bioprocess industry is embracing E2500 to improve system designs and reduce costly validations.…

Generic Biologics

      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…

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…

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…