Saturday, October 1, 2011 Daily Archives

Toward Defined Culture Conditions for Pluripotent Stem Cells, Part 1

    On 31 March 2011, ~50 delegates attended a workshop organized by STEMCELL Technologies on implications of standard defined culture conditions for embryonic and induced-pluripotent human stem cells as part of the annual meeting of the UK National Stem Cell Network in York, UK. Researchers from both academia and industry need to develop a better understanding of those implications. Our company wanted to give them a better appreciation of key challenges facing ancillary material suppliers who manufacture standard defined…

Limited Analytical Technologies Are Inhibiting Industry Growth

    Progress in the development of bioprocessing-related assays and analytical instrumentation has not kept up with industry demands. The industry wants analytical technologies (especially for single use) to help improve productivity, optimize and monitor processes, provide real-time product quality control, and characterize biosimilars. These trends are reflected in our recent survey data. Over 30% of biopharmaceutical manufacturers and contract manufacturing organizations (CMOs) have expressed demands for improved assays and analytical equipment (1). BioPlan Associates’ eighth annual survey of biopharmaceutical…

Monoclonal Antibody Manufacturing

    Continuing the theme of this occasional series, we examine the role of manufacturing in the supply chain in terms of what is required to deliver affordable medicines to patients. The industry has debated the relevance of manufacturing costs in the overall big picture (1). Rising manufacturing costs as a proportion of the overall selling price coupled with increased competitive pressures creates a strong drive to reduce manufacturing costs. However, cost of goods (CoG) is not the only strategic…

A Best-Practices Exchange with Solutions to Common Problems and Techniques for Next-Generation Products Formulation Strategies for Protein Therapeutics

Now in its 11th year, IBC’s Formulation Strategies for Protein Therapeutics is a must-attend annual conference for formulation, delivery, and analytical development scientists from biotherapeutic development organizations around the world. The 28 case studies to be presented at this year’s conference were chosen to offer solutions to the most pressing day-to-day challenges in formulation development for therapeutic proteins. Additional presentations address cutting-edge protein science from leading academics and include briefings on strategic issues of importance to this important field: Solutions…

Recovery and Purification

    A downstream process that leverages the advantages of innovative technologies such as disposables, in-line monitoring, and high-throughput systems as well as the robust methods for its harvest and purification steps can significantly improve in a company’s time (and cost) to clinic or commercialization. The 2011 BioProcess International Conference and Exhibition provides forward-thinking presentations that can help you define, characterize, and simplify your downstream design space.   Process Development   Many biomanufacturers have already experienced the advantages of high-throughput…

Cell Culture

After over three decades of progress, cell culture bioprocesses in the biopharmaceutical industry continue to evolve. From early laboratory culture methods to vaccine production in the mid-20th century, the first biopharmaceutical companies had a century of basic understanding to build on when they developed the first recombinant expression systems. Since those first efforts in the 1980s, a succession of cell culture biologists and engineers have improved processes using a series of products that have been increasingly specified for their use.…

Product Life-Cycle Management

    Even before the advent of biosimilar products, biopharmaceutical products faced life-cycle concerns. The discovery–development–licensure process is just the beginning. Drug sponsors hope each new product will enjoy decades of relevance and generate millions of dollars in sales. But “me-too” products will come along, process technologies will change, and patents will expire. Even product innovators have to think about comparablity. Out-of specification results can signal problems that have their roots in raw material choices and sources, equipment deviations, analytical…

Manufacturing Management and Analytical Strategies

    The need to streamline costs, shorten development timelines, and stretch valuable resources is driving biomanufacturers to seek innovative ways of enhancing manufacturing efficiency. Analytical methods for process development and validation as well as use of production technologies such as disposables and supply chain logistics can help companies establish facility flexibility. Effective management of a good manufacturing practice (GMP) facility requires a keen eye on all those factors. The Enhancing Manufacturing and Development Efficiency track of the 2011 BioProcess…

From The Organizers

    Welcome to the BioProcess International Conference and Exhibition, your one-stop industry resource for driving down costs; improving quality; achieving rapid, robust, and resilient process development and manufacturing. This week you will have an opportunity to explore challenges, uncover solutions, and develop opportunities at the largest and most highly respected event solely dedicated to biopharmaceutical manufacturing. This year, the conference features more than 50 presentations with new, previously unpublished data as well as many more to choose from, including…

From The Editor

      Not long ago I assembled a few current and former coworkers to meet with a young woman who is contemplating a career in journalism. Part of that visit involved comparing experiences of those who had been in the field for many years with those who had finished their formal education only a few years ago. We wondered whether the field still welcomes newcomers with degrees other than in journalism; or whether publishers now insist on that specific…