Saturday, September 1, 2012 Daily Archives

Specialty Focus Sessions

    The value of a good bioprocessing industry conference would not be complete without presentations on the most up-to-date information about the current technologies and research in the fastest growing segments of the field. Thanks to their promising therapeutic outlooks in areas such as cancer, antibody–drug conjugates (ADCs) have created a growing number of novel biologics candidates in various phases of clinical trials. Issues associated with their scale-up, processing, and characterization remain, however. Meanwhile, novel analytical technologies have been…

Agenda-at-a-Glance

    For 2012, The BPI Conference and Exhibition returns to Providence, RI and the Rhode Island Convention Center ()   For 2012, The BPI Conference and Exhibition returns to Providence, RI and the Rhode Island Convention Center ()   For 2012, The BPI Conference and Exhibition returns to Providence, RI and the Rhode Island Convention Center ()   For 2012, The BPI Conference and Exhibition returns to Providence, RI and the Rhode Island Convention Center ()   For 2012,…

Enhancing Manufacturing and Development Efficiency

    Boosting manufacturing efficiency remains a key focus area as bioprocessing companies continue to leverage best-practice strategies for their operations. Multiproduct facilities especially are having to shift resources and maximize flexibility within narrow cost windows. Such flexibility may require reevaluation of facility layouts and design, implementation of new technologies including single-use systems, and renewed approaches toward technology transfer, operations schemes, and raw-material supply chain challenges.   Manufacturing Optimization   Manufacturers are increasingly seeking ways to increase process and personnel…

The Votes Are In!

On 15 August 2012 BioProcess International announced the 36 finalists for the 2012 BioProcess International Awards — Honoring a Decade of BioProcess. Finalists were determined through an independent judging process, and the results were tabulated and certified by Deloitte & Touche, LLC. To view the names of the finalists and descriptions of their industry contributions, please visit http://awards.bioprocessintl.com/finalists — or read the special 20-page award finalist insert in BioProcess International’s September supplement, The Official Pre-Event Planner of the BPI Conference…

Product Life-Cycle Planning

    Quality by design (QbD) has changed the biopharmaceutical industry’s approach to chemistry, manufacturing, and controls at its core. And that’s changing how companies plan for and execute the life cycle of their products. New candidates entering development especially benefit from strategies implemented from the start. The 2012 BioProcess International Conference and Exhibition devotes a track on Tuesday and Wednesday (9–10 October 2012) to examining those strategies in the dawning age of biosimilars: from regulatory approaches and analytical innovation…

Creating a Corporate Compliance Program

    Regulatory compliance is an evolving concept that must be flexible enough to adapt to both a company’s unique business climate and to changing regulatory circumstances. Although standard operating procedures (SOPs) are a compliance tool and can and should be strongly recommended, they cannot become the end of a process. Compliance is not a set of standards or procedures that sit on a shelf until something goes wrong. Instead, compliance requires thought in creating a code of conduct and…

Cell Culture and Upstream Processing

    Cell culture processes are a vital part of manufacturing, yet the bioprocessing industry still needs optimized process development approaches. Increasing interest in chemically defined media, perfusion cell processes, and high-throughput approaches are driving the need for better understanding of cell culture characterization and process development for current and next-generation protein therapeutics.     Process Development   Optimizing the business process of cell line development involves creating competitive advantages with increased efficiency and reduced risk. “Intelligent business practices that…

From the Editor

    Another successful BioProcess Theater at the Biotechnology Industry Organization’s annual BIO Conference and Exposition (Boston, MA) led BPI into the summer on a high note. In fact, a number of our presentations this past June attracted standing-room–only audiences in the exhibit hall’s BioProcess Zone, with steady attendance throughout the three days of the event. The BioProcess Theater creates a forum for discussion of technologies and applications for both exhibit-hall–only attendees and full-conference registrants. Presenters enjoy long conversations afterward…

From the Organizers

    Welcome to the industry meeting place for exchanging real-world solutions for improving speed to market, cost, and quality. This week in Providence, RI, you will have an opportunity to explore challenges, uncover solutions, and develop opportunities at the largest and most highly respected event that is solely dedicated to biopharmaceutical manufacturing. This year, the conference features more than 55 presentations with new, previously unpublished data — and many more to choose from, including Updates from the US Food…

Legacies in Bioprocessing

Bioprocessing is full of legacies. Our remote ancestors discovered fermentation: microbial magic that transformed fruit to wine and grain to beer. Building on the work of Edward Jenner and others, Edward Ballard systematically reinfected cattle to make vaccines. Louis Pasteur revolutionized both fermentation and vaccination by showing that different microbes caused fermentation and spoilage (saving wine and beer production from disastrous batch contamination), establishing the germ theory of disease, and using that knowledge to develop new vaccines against endemic infections.…