IBC’s Biopharmaceutical Development and Production Week provides updates on current and emerging methods to improve your bioproduction capabilities and delivers strategies to help you overcome process challenges and accelerate production of the biopharmaceutical industry’s emerging new wave of monoclonal antibodies (MAbs) and novel molecules. Methods The Monday and Tuesday tracks provide a firm foundation in practical methods and strategies for specific unit operations. This can help you tackle some of the specific challenges in your job function. Implement process validation…
2012
Establishing Strategic Supplier Partnerships to Facilitate Manufacturing Success
In November 2009, Talecris Biotherapeutics announced an ambitious US$269 million expansion of its Clayton, NC, manufacturing facility. The company was subsequently purchased by Grifols, Inc. in 2011. Constructing a new facility with a state-of-the-art manufacturing process intended to generate clinical products involves top-notch project management, exceptional fortitude, and numerous supply chain decisions. Suppliers are often relied on to provide standard product support. When used effectively, they can be an invaluable resource beyond basic services. Additional support may include…
Understanding the Patient Journey
The biopharmaceutical industry is abuzz with talk regarding a 2011 US Food and Drug Administration (FDA) guidance on human factors and the mitigation of user-based risk in the development of medical devices (1). As expected, his talk is often accompanied by a sense of anxiety. Device developers and the growing number of biomanufacturers developing combination drug–device products now need answers to usability questions they are hardly familiar with. Wrong answers may have direct (and troubling) implications from a…
Lean Six Sigma
About 10 years ago as a vice president of Avecia Biologics, I wrote an article for an early issue of BioProcess International looking ahead at likely changes in biomanufacturing (1,2,3). For the best part of the intervening period, Avecia Biologics and Diosynth slugged it out in the marketplace, each trying to grow its contract manufacturing business at the expense of the other. But in a life-altering two-year period between 2009 and 2011, both companies saw their realities and…
Global Marketplace
Cold-Chain Tracking Product: PakSense BIOmed XpressPDF package label Applications: Drugs, vaccines, and other temperature-sensitive biologics Features: Calibrated to NIST standards, PakSense BIOmed XpressPDF labels help companies monitor and record product package temperatures. The size of a sugar packet, each waterproof label features a USB connection that automatically generates PDF files. Unlike bulky recorders that read ambient conditions, a label sensor measures the temperature of the surface on which it is attached once a minute. Results can be read at a…
Biopharmaceuticals On Demand
By 2016, five of the top 10 biopharmaceuticals are expected to be monoclonal antibodies (MAbs). Follow-on (biosimilar) versions of those blockbusters will most likely become available in later years due to patent expiry and the introduction of legislation for biosimilars around the world. Personalized therapies will drive the fractionation of the biopharmaceutical market, trending biomanufacturing toward smaller batch sizes and campaign-based production schemes. A growing need for flexible, multipurpose, and cost-effective manufacturing will significantly affect the design of…
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…
The Dinosaurs Can Evolve
Barring fire, major earthquakes, or volcanic catastrophe, concrete is good for centuries — the Pantheon has been in continuous use since 126 AD. The long expected life and high initial cost of biomanufacturing buildings and equipment builds legacy into the system from the start. And the imperatives of launching a new biotechnology industry in the 1980s led to the building of many facilities within a few years to produce the first wave of recombinant DNA products. I spoke…
Participating in the Rx-360 Pilot Joint Audit Program
The Rx-360 consortium has had a profoundly positive impact on pharmaceutical manufacturers and their suppliers. As an international, nonprofit, pharmaceutical supply chain group (established in 2009), its mission is to “create and monitor a global quality system that meets the expectations of industry and regulators that assures patient safety by enhancing product quality and authenticity throughout the supply chain†(1). The list of consortium members (www.rx-360.org/Membership/ListofMembers/tabid/71/Default.aspx) is diverse and presently includes both pharmaceutical manufacturers and suppliers (24 and…
The Global Cold Chain
In biopharmaceutical development, ancillary business operations such as logistics and supply chain management are frequently perceived as secondary objectives to the ultimate goal of discovering treatments and cures for devastating diseases. However, in the hypercompetitive world of drug development, forward-thinking companies have found that optimizing their clinical-trial supply chain can provide a strategic advantage to accelerating drug development. The globalization of clinical research has made the safe, punctual, and compliant transport of study drugs and other temperature-sensitive materials increasingly complex.…