2011

Production and Purification of a PER.C6-Expressed IgM Antibody Therapeutic

    Immunoglobulin G (IgG) antibodies have been used to treat cancer for many years (1). Another class of antibodies—immunoglobulin M (IgM)—has been overlooked in spite of offering unique advantages that make them highly desirable as cancer therapeutics. Serving a valuable function in our innate immune system, IgM antibodies are the first to be secreted when an abnormal cell is present (2). These antibodies play a critical role in recognition and elimination of infectious particles (3,4), in removal of intracellular…

Analysis and Immunogenic Potential of Aggregates and Particles

    The conclusion of this CMC Forum continued to focus on the latest developments in detection and characterization of protein aggregates (1). Afternoon sessions detailed the most recent experiments probing the role of protein aggregates in immunogenicity, with discussions on the best models to use and initial results. Topics included potential thresholds for immunogenicity, linking laboratory and clinical data, and predicting and testing potential immunogenicity of products throughout a development lifecycle.     Afternoon Sessions   Amy Rosenberg (Division…

Differential Cell Culture Media for Single-Cell Cloning

    Recombinant therapeutic protein production using cell culture systems is a US$70 billion market. Most biotherapeutic proteins, including monoclonal antibodies (MAbs), are produced in Chinese hamster ovary (CHO) cells, which can generate the posttranslational modifications required for full biological function. Single-cell cloning is an important step in generating homogenous recombinant protein-producing mammalian cell lines. Recent advances in media development technologies have enabled limiting dilution cloning (LDC) and protein production in a serum-free environment to meet regulatory requirements.   LDC…

Glass Delamination and Breakage

    Although glass is widely considered to be the most traditional and cost-effective option for a parenteral drug container or delivery system, it may not always be the most economical or the best choice for certain products. With knowledge emerging about the suitability of materials in contact with drug products, it is time to look at alternatives that may offer a more appropriate choice and mitigate the risks associated with glass. As single-use technology finds its way into upstream…

Global Marketplace

  High-Throughput Osmometry   Product: Advanced 20G osmometer Applications: Cell culture process development and optimization Features: New approaches to accelerate cell culture process development and optimization require higher sample throughput for osmolality testing. The Advanced 20G high-throughput osmometer was developed by combining state-of-the-art osmometry technology and robotics within a parallel sample processing scheme. Samples can be analyzed in 96-well format within 35 minutes, with the same accuracy as provided by stand-alone osmometers. This system has been applied to support osmolality…

IBC’s 28th Annual Antibody Development and Prodution

Antibody Development and Production covers the entire spectrum of topics related to development and production of the most promising therapeutics in the biopharmaceutical industry. An estimated 30% of new drug products likely to be licensed in the next decade will be antibodies. With the reality of their biosimilar equivalents getting closer, companies need to develop processes faster to preserve their time on the market free from generic competition and keep costs down. With that in mind, we developed the 2012…

Clinical Development of Biosimilars

    Biosimilars require comparative studies that are different from the typical placebo-control clinical trials for first-generation proteins. A typical clinical trial programs must show equivalence of a biosimilar to the originator protein. Hans-Peter Guler, senior vice president of clinical development at INC Research, recently discussed with me the primary objectives and approaches to conducting an equivalence design.   By contrast with trials for originator proteins, equivalence trials require a different statistical approach. The biosimilars company needs agreement from the…

From the Editor

      Kudos once again to our IBC colleagues for another excellent BioProcess International Conference and Exposition. Throughout the week of 31 October– 4 November more than 1,400 attendees and 125 exhibitors engaged in lively discussions on critical issues affecting our industry. The Long Beach, CA, convention center proved to be a comfortable and accessible venue for multiple session tracks, technical workshops, and seminars. Among the trends and topics that made frequent appearances in presentations were the ongoing challenges…

Innovation Is One Key to Economic Future Success

    Following up on its 28 June 2011 innovation forum, the Hamilton Project (an economic policy initiative of the Brookings Institution, www.hamiltonproject.org) created a new document detailing A Dozen Economic Facts About Innovation for the United States. Drawing from insightful comments by panelists during the event, authors Michael Greenstone and Adam Looney focused on three specific points: Innovation has historically improved the US standard of living through higher wages, lower prices, and health advancements. The pace of innovation has…

Americans Say Yes to Stem Cell Research

    University of Nevada, Reno, researchers reported in Nature Biotechnology this past summer on their survey of >2,000 Americans about stem cells and other controversial research topics. Supporters of using embryonic stem cells in disease research outnumbered opponents five to one. Most respondents (>66%) also approved of induced pluripotent stem cell treatments. But opponents of stem-cell–based cosmetic treatments outnumbered supporters by almost two to one.