September 2012 Supplement

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 performance. Chris Pacheco of Amgen says activities toward achieving operational excellence should focus on team performance and process cycle time. His presentation will open the “manufacturing optimization” sessions on Tuesday. Pacheco will discuss strategies to help prevent and alleviate problems associated with production bottlenecks in the “critical path.” It also enables a facility ...

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 This year, the conference features more than 55 presentations with new, previously unpublished data — and many more to choose from, including Attendees can benefit from an expanded roster of preconference symposia (see below) to help them gain new skills and update their knowledge in a number of areas, learning from more than 180 case studies and cutting-edge presentations and consulting with more than 150 providers in the exhibit hall. This is your chance to develop valuable partnerships through rapid-fire “speed networking” and continued consultations with fellow attendees through our LinkedIn group online. With all these opportunities for gaining new...

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 Production Systems XCELLEREX SITE TOUR THURSDAY, 11 OCTOBER 2012 1:30–4:30 PM EXHIBIT HALL HOURS Tuesday 3:15–7:00 PM    Wednesday 9:45 AM–7:15 PM    Thursday 9:45 AM–1:40 PM DEDICATED POSTER VIEWING Wednesday 12:30–1:45 PM TWO-DAY TRAINING COURSES TAKE PLACEON TUESDAYAND WEDNESDAY, 9–10 OCTOBER 2012, 9:00–5:00 PM For details about the course agendas and instructors, visit www.IBCLifeSciences.com/courses

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 to involving partners the right way at the right time. AUDIENCE: PRODUCT AND PROCESS DEVELOPMENT, BUSINESS DEVELOPMENT KEYWORDS: OUTSOURCING, QBD, RISK, BIOSIMILARS, COMPARABILITY, PRODUCT AND PROCESS CHARACTERIZATION, TECHNOLOGY TRANSFER TAKE-AWAY: CREATE MORE VALUE AND ENHANCE QUALITY FOR PRODUCTS AND PRODUCT CANDIDATES THROUGH THE LATEST STRATEGIES FOR PROCESS DESIGN, IMPLEMENTATION, AND CONTINUOUS IMPROVEMENTS. Performance By Design Product quality ...

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 the development assessment of an IgG2 monoclonal antibody (MAb) using degradation pathways that were determined by early research stability studies and extended characterization of the molecule. Cation-exchange high-performance liquid chromatography (HPLC) analysis of material stored at elevated temperatures showed a severe shift toward acidic variants after a one-month storage. Liquid chromatography with mass spectromet...

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 engineers can experiment in a virtual space before working with real (often expensive) chromatography skids and other hardware. Using new and improved analytical methods and scalable equipment, a downstream group can establish a “design space” for a given process. Automation is beginning to make inroads. And vendors offer options for addressing the downstream bottleneck — many of them based on single-use technology. AUDIENCE:

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 developed to help manufacturers in areas such as process validation, quality by design (QbD), and characterization. Such analytical tools are facilitating manufacturers in the processing of vaccines, another rapidly growing area of the industry. AUDIENCE: PROCESS DEVELOPMENT, REGULATORY, ANALYTICAL, FACILITY DESIGN KEYWORDS: QBD, ANTIBODIES, CHARACTERIZATION, CELL LINES, BIOASSAYS, RISK MITIGATION, CHARACTERIZATION TAKE-AWAY: Get up-to-date on the ...

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 support scientific processes are essential in today’s competitive environment,” says Steve Lang of Janssen Research & Development. His Wednesday morning presentation will include case studies and “lessons learned” examples in cell culture process development. The talk will focus on preclinical enabling strategies and decision processes. AUDIENCE: UPSTREAM PROCESS DEVELOPMENT, QA/QC, ANALYTICAL KEYWORDS: CHO, M...