A Chemistry, Manufacturing, and Controls (CMC) Strategy Forum was held in January 2012 in San Francisco, CA, to examine the topic of rapid pharmaceutical product development. The purpose of this meeting was to promote an understanding of how best to increase the speed of product development, focusing on areas that improve chances of regulatory success while lessening the time it takes to get a product through development and onto the market. Participants also sought to identify and discuss…
2012
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…
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…
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…
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…
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…
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…
Developing an Integrated Continuous Bioprocessing Platform
Continuous upstream processing (perfusion) is not a new concept in the bioprocessing industry. Genzyme, Bayer, Centocor, and other companies have been implementing perfusion processes for many years. However, interest is now growing for extending this concept to downstream operations to create fully integrated continuous processing. During the past year, Genzyme has presented on and published about its advancement toward the development of an integrated continuous system (1). The company has completed proof-of-principle development at laboratory scale with different…
Encouraging In-House Disclosures In a Whistleblower’s World
Compliance officials have a great deal to worry about. They are judged by results and loaded with stress over the latest changes in government guidance documents and internal budget pressures. They need to continually update their programs to stay abreast of those developments, including revisions that target in-house processes to encourage disclosures from whistleblowers. Failure to provide for such revisions places both a company and individuals at risk Whistleblower Protection Expanded and Includes Rewards In response…
Toward Flexible Hybrid Facilities of the Future
As the bioprocessing industry has shifted away from traditional stainless steel bioreactors and vessels toward single-use technology, a new breed of manufacturing facilities has arisen. Flexible facilities take full advantage of traditional multiuse technologies and combine them with increasingly popular single-use technologies, offering an ability to mitigate risk and decrease manufacturing timelines. Although some companies have made the choice to remain strictly traditional (multiple use) and others have moved fully into single use, the flexible hybrid format gives…