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…
Saturday, September 1, 2012 Daily Archives
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 This year, the conference features more than 55 presentations with new, previously unpublished data — and many more to choose from, including Updates from the US Food…
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…
Special Events
SYMPOSIA ON MONDAY, 8 OCTOBER 2012, 1:00–5:00 PM #1: Biosimilars: Defining Successful Development Strategies in an Evolving Regulatory Environment #2: Best Practices for Implementation Challenges with Single-Use Systems #3: Best Practices in Managing Variability of Raw Materials #4: Regulatory Requirements in Preclinical CMC Development #5: Best Practices in Cleaning and Cleaning Validation: A Science-Based and Integrated Approach for Biopharmaceuticals #6: Risk Management in Fill–Finish Operations #7: CMC Project Management throughout the Product Development Life Cycle #8: Microbial Protein…
Thermo Fisher Hosts a Series of BioProcessing Seminars
Thermo Fisher Scientific wrapped up its North American series of BioProcessing Technology Seminars in June 2012 in North Carolina. Over two months, the company and local biomanufacturers hosted six all-day events at different venues focusing on cell culture media design, single-use systems, bioreactor technologies, and performance optimization. Agendas included interactive presentations from industry experts and typically ended with a tour of a local bioprocessing facility. On 21 June in Cambridge, MA, Eric Langer (BioPlan Associates) kicked off the fifth meeting…
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…