September 2012 Supplement

Formulation and Delivery

    Biopharmaceutical formulation and delivery are more than science; they also must take into account patient preferences and behavior, the biology of diseases being treated, and even the concerns of legal, sales, and marketing groups. But science is the foundation. Formulation work has become more methodical and quantifiable thanks to advancing analytical technologies — which brings quality by design (QbD) into formulation laboratories. The vast majority of biotherapeutics and vaccines are parenteral drugs — many of them lyophilized and…

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…

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 This year, the conference features more than 55 presentations with new, previously unpublished data — and many more to choose from, including Updates from the US Food…

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…

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…

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…

Recovery and Purification

    Modern separation and purification engineers are hard tasked with handling concentrated feed streams, recalcitrant proteins, and new contaminant profiles coming from the use of serum-free culture media. With regulatory, public, and industry attention increasingly focused on the subject of viral safety, for example, a risk-based approach following an FDA quality systems initiative continues to build momentum. That regulatory perspective affects how recovery and purification unit operations are designed and conducted. Process modeling software is becoming increasingly sophisticated, so…

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…

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…