2012

Novel Single-Use Sensors for Online Measurement of Glucose

    According to an FDA guidance document, process analytical technology (PAT) tools “are intended to support innovation and efficiency in pharmaceutical development” (1). The agency encourages manufacturers to use a PAT framework for developing and implementing effective innovative approaches in development, manufacturing, and quality assurance. The sensors described here are one possible response to the requirement of systems by analyzing and controlling critical cultivation parameters with real-time process measurements.   Working Principle   Glucose was measured using a #CITSens…

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…

Poster Presentations

  Enhancing Manufacturing Development Efficiency   Svetlana Dukleska (Merck) Early Research Stability Studies Can Aid in Rapid Screening of Potential Drug Candidates In a competitive research and development (R&D) space with tight time lines, it is important to have a toolbox of extended characterization and analytical assays for rapid screening of potential candidates. Additionally, early research stability studies can provide initial information on potential degradation pathways for screening candidates, for purification development, and for establishing stable formulations. Herein, we show…

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…

Advancements in Processing That Optimize Samples for Future Research

    Many factors contribute to the quality of biospecimen collections, and most are not mutually exclusive. How we assess the value of a biosample at the time of collection may be very different from at the time of analysis, which can be (and often is) an event in the distant future. To help ensure quality and create a sample resource that is not easily depleted, both novice and experienced “biobankers” can follow some general sample life-cycle management principles to…

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…

Global Marketplace

  Product Development   Service: Contract development and manufacturing Applications: Clinical- and commercial-scale complex biologics Features: Therapure Biopharma specializes in biologics development, scale-up, and manufacturing. At its 130,000-ft2 CGMP facility in Toronto, Ontario, Canada, the company offers cell-line, process, and analytical development; product manufacturing and testing; and aseptic fill–finish and lyophilization. It has >20 years of experience working with mammalian and primary cell cultures, whole blood, and plasma sources. Contact Therapure Biopharma www.therapurebio.com     Capsule Filters   Product: CM…

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,…

BioProcess International Conference and Exhibition

Expand your knowledge with unparalleled access to new, unpublished data and exclusive case studies from companies of all sizes and perspectives at the most comprehensive event for those directly involved with improving the speed, cost, and quality of developing and manufacturing biotherapeutics. This event will help you improve manufacturing and development efficiency, enhance process understanding and quality, advance cell culture and upstream processing, streamline recovery and purification, and optimize the quality and novelty of your next-generation biologic drug products. To…

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…