2011

Addressing Image-Based Compliance and Validation Issues

    Review times for 510(k) submissions have increased by >55% since 2005 because of poor-quality submissions by medical device manufacturers, according to a US FDA July 2011 report (1). Such setbacks can debilitate research and development (R&D) budgets of medical device and pharmaceutical companies and significantly affect their return on investment. As the FDA increases scrutiny of submissions, organizations must ensure adequate controls in assessing drug and device efficacy for preclinical animal studies and clinical trials. Doing so lends…

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…

Trends in Perfusion Bioreactors

    Single-use bioprocessing equipment has come to thoroughly dominate precommercial biopharmaceutical production in only a decade. Yet even with this breakthrough, performance and cost pressures on biopharmaceutical facilities continue to grow. Demands for greater productivity, more efficiency, and lower costs are resulting in an unrelenting push for upstream improvements. Some people in the industry are predicting that perfusion bioreactor technologies may be the next revolution in bioprocessing (1). Perfusion may possibly become a dominant single-use bioreactor technology, with fed-batch…

Sustainability in Bioprocessing

    The concept of sustainability has evolved over the past few decades to describe conditions for harmonious coexistence of industry and nature while meeting socioeconomic requirements of present and future generations. For this environmentally focused report, I like the simple definition offered by Armstrong International, a provider of steam, air, and hot water systems that improve utility performance, lower energy consumption, and reduce environmental emissions. According to a brochure that in part describes its work with Pfizer, Armstrong defines…

Analysis and Immunogenic Potential of Aggregates and Particles

    The number of biotherapeutics on the market has rapidly increased during the past several years. Such proteins commonly exhibit a concentration-dependent propensity for self-association, which often leads to the formation of aggregates that range in size from nanometers (oligomers) to microns (subvisible and visible particles). Publications two years ago focused attention on the potential immunogenicity of active-ingredient aggregates ((1,2,3,4). The authors discussed lack of specificity of compendial measurements and inability of other current methods to address potential effects…

Imaged Capillary Isoelectric Focusing for Charge-Variant Analysis of Biopharmaceuticals

    Analyzing charge variants of therapeutic proteins is critical for characterizing and monitoring quality attributes of antibodies. Charge variants include deamidation, formation of N-terminal pyroglutamate, aggregation, isomerization, sialylated glycans, antibody fragmentation, and glycation at the lysine residues. In some cases, such changes affect binding, biological activity, patient safety, and shelf life. The biopharmaceutical industry relies on tools such as ion-exchange chromatography (IEC), isoelectric-focusing gel electrophoresis (IEF), and capillary equivalents such as capillary isoelectric focusing (CIEF) and imaged CIEF (iCIEF)…

Understanding Chromatographic Media Ligand Density

    The concept of quality by design (QbD), although not new, has presented implementation opportunities and challenges to both the bioprocessing industry and regulators (1,2,3,4). Tools such as design of experiments (DoE), cause and effect analysis, and multivariate analysis provide for systematic risk assessment and help identify critical quality attributes (CQAs) and critical process parameters (5,6,7). QbD is intended to ensure that manufacturing processes make products that meet predefined quality parameters. Key elements in defining such parameters (quality profile)…

GLOBAL MARKETPLACE

        Aseptic Material Transfer   Product: FlexFill single-use biocontainer transfer assembly Applications: Aseptic transfer of bottled media, sera, reagents, supplements, buffers, and microcarriers to bioreactors Features: Meissner’s FlexFill assembly is designed for applications requiring fast and dependable aseptic transfer of small liquid process volumes. Its large screw-cap port allows for rapid and convenient filling of disposable biocontainers in laminar flow hoods using a portable stainless steel FlexCessory stand. The assemblies can be customized to support a range…

IBC’s Fourth Annual AsiaTIDES

The AsiaTIDES conference is a unique opportunity to update your knowledge of the latest research and manufacturing technologies for oligonucleotide-and peptide-based therapeutics and access this rapidly growing market area. Hear the latest reports from around the world — a program agenda not available at any other event in Japan — at a convenient forum in Tokyo. This event continues to be the premier forum to get a comprehensive update, meet key players, and increase your knowledge of the oligonucleotide-and peptide-based…