September 2010

Poster Presentations

Product Lifecycle Management Jayne Hesley, applications scientist in marketing for Molecular Devices, Inc. (Sunnyvale, CA) Homogeneous Antibody Binding Assay: Comparing Imaging Systems and Optimizing Acquisition Parameters for High-Throughput Screening Hybridoma cell lines are cultured to produce monoclonal antibodies for use in diagnostics, vaccine development, or therapeutics. One well-accepted assay for screening the antibody-containing supernatant of hybridomas is to capture the antibody on the surface of beads (

Sequence Variant Analysis Using Peptide Mapping By LC–MS/MS

    Monoclonal antibodies are usually expressed in mammalian cell lines and are produced in several variants known as isoforms (1,–2). Microheterogeneity can result from posttranslational and enzymatic modifications as well as those caused by processing, alteration, storage, and incorrect translation of the target protein (1,3). Common sources of heterogeneity include Fc glycosylation, partial carboxypeptidase processing of heavy-chain (HC) C-terminal lysine residues (4), deamidation or isomerization (5), Fc methionine oxidation, hinge-region fragmentation (6), aggregation, and sequence variants. Sequence variants are…

Minimizing the Environmental Footprint of Bioprocesses

    Biomanufacturers must take active measures to minimize their environmental footprints and promote environmental sustainability. The collateral benefit of reducing environmental footprint often is viewed as only a secondary consideration after cost of goods and product quality. Biopharmaceutical processes are 80% defined by the time of proof-of-concept studies (clinical trial stage 2b). This milestone is before the official technical transfer to commercialization or manufacturing organizations and almost always before the environmental evaluation of a production process. This step is…

Demonstrated Performance of a Disposable Bioreactor with an Anchorage-Dependent Cell Line

    Increased adoption of disposable storage vessels and mixing systems for biopharmaceutical manufacturing operations has provided economic and efficiency benefits to a number of life-science companies. Single-use technologies have reduced validation requirements, shortened turnaround times, eliminated cleaning regimes, increased the speed of set-up procedures, and facilitated the development of flexible manufacturing platforms. Many biomanufacturers have sought to extend those benefits into the field of cell culture by using disposable bioreactors. Here we describe work undertaken to develop and demonstrate…

IBC’s 14th Annual Well Characterized Biologicals Practical Case Studies, Analytical Strategies, and Regulatory Perspectives for Protein Product Characterization

IBC’s Well Characterized Biologicals conference is the top forum for hearing industry case studies and unpublished new data on the challenges, strategies, and technologies involved in protein characterization. Register now for exclusive access to meet FDA reviewers and industry experts who will share their insights to help you implement new approaches and avoid common pitfalls in your own characterization projects. Hear first-hand from FDA reviewers about their “pet peeves” and suggestions to help you improve your IND packages and characterization…

Building Regulatory Compliance for Personalized Medicine

    Regulatory compliance is the means by which biopharmaceutical companies bring new medicines to market. But as we embark on developing and bringing to market more complex, more personalized medicines in the 21st century, we are about to find that our most experienced sources of compliance know-how and intelligence are getting ready to leave for the comforts of retirement. Demographics are working against the biopharmaceutical industry.   Survey Results   A 2006–2007 survey by the University of Southern California…

Global Marketplace

  Single-Use Bioreactors         Product: Modular, integrated bioreactors Applications: Single-use cell culture Features: PBS Biotech has introduced its “next-generation” single-use bioreactors. The first three models support maximum working volumes of 3 L, 15 L, and 80 L to support expansion and process scale-up from R&D to pilot plants. The modular, preconfigured bioreactors feature an integrated controller with a graphical user interface, proprietary low–shear-stress Air-Wheel agitation, automated sampling, and an on-board database. Each unit is built to order,…

Managing Manufacturing Networks

    Smart management and maintainance of multiple production sites is essential for global manufacturers and suppliers to reach both existing and emerging markets. Optimal performance of these networks requires keen efficiency, due diligence, and cost reduction. Biomanufacturers are taking a close look at their facilities when developing strategies for reducing time to clinic and decreasing the cost of operations, including labor, energy, raw materials and supplies, and other resources. The Managing Manufacturing Networks track of the BioProcess International Conference…

Manufacturing Convergence Technologies

    Many regenerative medicine products represent a convergence of pharmaceutical, biologic, and medical device technologies. Although such products could have a great impact on medicine, they often pose significant challenges for their developers, requiring companies to incorporate competencies from several technology sectors. By addressing commercial regulatory and manufacturing challenges at an early stage in product development, these companies are more likely to succeed in reaching their commercial goals. Exact regulations governing the manufacture of a convergent technology — or…

Containment of High-Potency Products in a GMP Environment

Many modern medicines are highly potent, with only tiny doses required to achieve a therapeutic effect. But a nanomolar medicine poses extra hazards during manufacturing, whether the product is a biologic or a small molecule. These issues have to be evaluated and addressed in the design of a manufacturing facility for such products. Not only is it vital that the product not become contaminated, but employees and the general public must be protected from the product. Exposure to just a…