Welcome to the BioProcess International Conference and Exhibition, your one-stop industry resource for driving down costs; improving quality; achieving rapid, robust, and resilient process development and manufacturing. This week you will have an opportunity to explore challenges, uncover solutions, and develop opportunities at the largest and most highly respected event solely dedicated to biopharmaceutical manufacturing. This year, the conference features more than 50 presentations with new, previously unpublished data as well as many more to choose from, including This annual event also offers an expanded roster of preconference symposia to help you gain new skills and update your knowledge in a variety of areas. Learn from more than 180 case studies and cutting-edge presentations. Consult with more than 150 product and service providers in the exhibit hall. Develop valuable partnerships through rapid-f ire speed networking. And take advantage of continued consultations with fellow attendees through ou...
The need to streamline costs, shorten development timelines, and stretch valuable resources is driving biomanufacturers to seek innovative ways of enhancing manufacturing efficiency. Analytical methods for process development and validation as well as use of production technologies such as disposables and supply chain logistics can help companies establish facility flexibility. Effective management of a good manufacturing practice (GMP) facility requires a keen eye on all those factors. The Enhancing Manufacturing and Development Efficiency track of the 2011 BioProcess International Conference and Exhibition will provide presentations, symposia, and workshops that discuss strategies for improving production flexibility and reducing risk so that bioprocessing companies can be ready for production changes while keeping costs at a minimum. AUDIENCE: PROCESS DEVELOPMENT, MANUFACTURING, ANALYTICAL METHODS KEYWORDS: PLATFORM PROCESSES, SINGLE-USE, SUPPLY CHAIN, FACILITY DESIGN, MONITORING, CHARACTERIZATION TAKE...
Even before the advent of biosimilar products, biopharmaceutical products faced life-cycle concerns. The discovery–development–licensure process is just the beginning. Drug sponsors hope each new product will enjoy decades of relevance and generate millions of dollars in sales. But “me-too” products will come along, process technologies will change, and patents will expire. Even product innovators have to think about comparablity. Out-of specification results can signal problems that have their roots in raw material choices and sources, equipment deviations, analytical method limitations, or training and standard operating procedures. Regulatory authorities expect to see appropriate corrective and preventive measures taken. And if process changes become necessary, they must be reported in compliance with the rules. Risk management is importantwhen it comes to making product and process-related decisions over time. And quality by design (QbD) approaches to process development, validation, and integration w...
After over three decades of progress, cell culture bioprocesses in the biopharmaceutical industry continue to evolve. From early laboratory culture methods to vaccine production in the mid-20th century, the first biopharmaceutical companies had a century of basic understanding to build on when they developed the first recombinant expression systems. Since those first efforts in the 1980s, a succession of cell culture biologists and engineers have improved processes using a series of products that have been increasingly specified for their use. Product titers rose exponentially, and the characterization of media and cell lines steadily improved. While even more knowledge is amassed in the literature as well as through personal experiences and company intellectual property, this evolution will be ongoing. The BioProcess International Conference and Exhibition provides an annual update of progress in cell culture. This year’s program reflects that evolution in process and media optimization for antibodies, c...
A downstream process that leverages the advantages of innovative technologies such as disposables, in-line monitoring, and high-throughput systems as well as the robust methods for its harvest and purification steps can significantly improve in a company’s time (and cost) to clinic or commercialization. The 2011 BioProcess International Conference and Exhibition provides forward-thinking presentations that can help you define, characterize, and simplify your downstream design space. Process Development Many biomanufacturers have already experienced the advantages of high-throughput systems and platform processes in their efforts to accelerate process development and reduce time to clinical trials. The preponderance of biologics on the market today are monoclonoal antibodies (MAbs), which have a well-established, well-characterized manufacturing process. Although many MAbs can undergo platform processes, others cannot and so require further development. At the BPI conference, Deepa Nadarajah (bioprocess en...
Now in its 11th year, IBC’s Formulation Strategies for Protein Therapeutics is a must-attend annual conference for formulation, delivery, and analytical development scientists from biotherapeutic development organizations around the world. The 28 case studies to be presented at this year’s conference were chosen to offer solutions to the most pressing day-to-day challenges in formulation development for therapeutic proteins. Additional presentations address cutting-edge protein science from leading academics and include briefings on strategic issues of importance to this important field: Formulation Strategies is colocated with the BioProcess International Conference and Exhibition. This provides the opportunity to visit with more than 150 suppliers of bioprocess technology and services and network with over 1,500 industry leaders. These topics are new this year : Conference Sessions Keynotes “Understanding How Solution Conditions Affect Stability by Investigating Site-Specific Changes within Proteins,”