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 and Exhibition will include sessions (see box below) highlighting the technology, innovation, and strategic business approaches to optimize performance of current operations and prepare new facilities to meet future technological challenges.
Modernizing Facilities with New Process Technologies
How much and when to invest in novel technology certainly depends on the unique needs of each company. Biomanufacturers should determine how the new tec...
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 (<10-μm diameter microspheres) and then measure the captured amount by tagging with a fluorescently labeled secondary antibody and imaging the beads' fluorescence. A similar assay can be done to measure ligand-binding on cell surfaces. Robust homogeneous assays are straightforward to develop and these assays can be automated and scaled up to 1,536-well plates because no washing away of excess antibody or label is required. These studies show that the IsoCyte DL scanning cytometer achieves sen...
Biopharmaceutical manufacturers have often explored the idea of real-time process control and monitoring — but until relatively recently, few case studies were available to help put all the information together in a coherent plan for true product lifecycle management. Shifting from previous BPI Conference programs that included a “scale-up” track, this year’s lifecycle track will reflect how companies are being encouraged to view development, design, and manufacturing as a continuum rather than (more “traditionally”) as a set of discrete phases. And continuous improvement throughout a product’s lifecycle, including postlaunch activities, is an important goal of these new approaches.
Upstream and downstream processes still exist as separate operating units, but much development and design work is performed in parallel these days. Different functional departments within biopharmaceutical companies are communicating with one another in ways not encouraged (or facilitated) before. Software to operate and trac...
Downstream processing can be complex, expensive, and time-consuming part of biotherapeutics production. Biomanufacturers are seeking technologies to clear bottlenecks and incorporate rapid in-or at-line analytics. Data obtained from using these methods under a well established design space can then help companies better characterize, monitor, and control their processes. The BioProcess International Conference and Exhibition features a Recovery and Purification track over three days, 22–24 September 2010, that will cover these issues and provide attendees with the information needed to manage downstream challenges.
Analytical Tools for Process Monitoring and Control
Unlike the semiconductor or chemical processing industries, the bioprocessing industry is relatively new to adopting process analytical technology (PAT)-based methods for monitoring and controlling unit operations. Nonetheless, some analytical methods familiar to the industry are gaining popularity as elements for improving process understandi...
With infusions of public and private venture capital as well as technological advances, vaccine development is entering a new golden age as one of the fastest growing sectors in the biotechnology industry. In the 19th and 20th centuries, immunization programs eliminated or controlled infectious diseases including smallpox, polio, measles, mumps, and rubella. The biotech era has made significant changes both in the number of companies involved in vaccine manufacture and the production systems they use.
BPI CONFERENCE SESSIONS
Wednesday, 22 September 2010
Keynote Presentation: Global Vaccine Production Challenges — Emerging Immunotherapeutics, Manufacturing Flexibility, and Reducing COGS
Lessons Learned from the 2009 Flu Season to Guide Rapid Vaccine Development and Manufacturing Scale-Up
Process Development for Novel Vaccines and Immunotherapeutics
Defending Biosimilar Competition: Bioprocess IP Protections for Next-Generation Vaccines and Immunotherapeutics
Process Development and Analytical Characterizat...
