Saturday, December 1, 2012 Daily Archives

A Decade of Success

    After nearly a year of planning, BPI announced the winners of its first awards program on the evening of 9 October 2012, during the BioProcess International Conference. Award finalists, sponsors, and guests joined us for a banquet ceremony in the Providence, RI, Convention Center to honor the 36 finalists for our Decade of BioProcess awards — and announce the 12 winners.   In his welcoming comments to the 150 attendees, BPI publisher Brian Caine noted that “during this…

Efficient, Flexible Facilities for the 21st Century

    A number of recent improvements in the engineering of high-titer expression vectors, in biopharmaceutical process development, and in facility construction have converged to present new opportunities for cost-effective, flexible, biomanufacturing facility construction. The evolution of requirements for biopharmaceutical facilities is driven by globalization of the biopharmaceutical industry, patent expirations of several blockbuster biopharmaceutical products, and the increasing shift in new product development away from blockbuster drugs and toward more personalized, niche products. An increase in product approvals (primarily…

Managing Cost Without Sacrificing Quality

    Over the past decade, significant pressures have threatened the future of many pharmaceutical and biopharmaceutical companies. Increasing drug development costs, declining research and development (R&D) productivity, mounting regulatory setbacks, and looming patent expirations — with fewer blockbuster therapies on the horizon — are collectively challenging many businesses to stay profitable and competitive within the industry. Many companies are intensifying their focus on reducing operating costs, particularly within manufacturing operations. This trend is almost an omnipresent feature of management…

Safety, Flexibility, and Efficiency

    International pharmaceutical and biotech companies are demanding solutions for current and future challenges of their industries — solutions that will stand the test of time while offering significant advances over current manufacturing techniques. Modern and highly proficient production lines for commercial manufacturing of parenteral drugs can represent a crucial criterion in the success of these companies. New and innovative high-speed filling lines for prefilled syringes present an excellent opportunity to meet current production demands. Following is an example…

A Framework for Process Knowledge Management

    Process development and manufacturing for biopharmaceuticals are often disjointed activities. Disconnects between groups within an organization can be aggravated by a lack of common terminology and poor data-management practices. Implementing a simple data model based on the ISA-88 standard for batch control can help companies capture process and facility data throughout their product life cycle (1). The first half of this two-part article illustrates how translating a process description to a structured electronic format could transform the bioprocessing…

Multiproduct Facility Design and Control for Biologics

    Multiproduct facilities are increasingly integral to corporate biologics network and supply chain strategies. Manufacturing capacity strategies ensuring appropriate facility design and procedural controls to manage the risks of producing multiple products are critical to the successful deployment of commercial and clinical supply plans. A Chemistry, Manufacturing, and Controls (CMC) Strategy forum was held in Bethesda, MD, in August 2011 to highlight various challenges, risks, and control strategies associated with multiproduct facilities. Multiproduct strategies for the manufacture of a…

Where’s the Viral Marketing When Spreading Information on Actual Viruses?

The importance of the Centers for Disease Control and Prevention (CDC, www.cdc.gov) in the tracking and treatment of viruses such as the influenza virus cannot be underestimated. It is a first line of defense against an influenza pandemic as well as a way to analyze seasonal influenza outbreaks to make certain that they do not deviate from their normal seasonal and geographic patterns. The CDC seeks to communicate with the American public through a wide variety of media. To its…