2011

Optimization, Robustness, and Scale-Up of MAb Purification

The biopharmaceutical industry needs faster and more efficient development of new drugs and their market introduction as well as shorter process development times for both upstream and downstream operations. It has become more commonplace to use high-throughput development techniques to save time (1). Development is also sped up by applying platform technologies based on the unsurpassed selectivity of protein A resins (2,3,4,5,6), which is the foundation for downstream processing of monoclonal antibodies (MAbs). This is the second of two articles…

GLOBAL MARKETPLACE

Antimicrobial Incubator Product: Multitron incubator shaker Applications: Cell line screening and seed cultures for larger validated processes Features: ATR has added an optional antimicrobial coating to the interior of its Multitron incubator shaker cabinet. This exclusively formulated coating inhibits the growth of bacteria, molds, and fungi over 100,000-fold. The coating is safe, effective, long-lasting, and approved for use in medical and food industries by independent certification. It is applied in production and can be ordered with any Multitron unit. All…

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…

Exchanging Real-World Solutions to Improve Speed, Cost, and Predictability BioProcess International Conference & Exhibition

The BioProcess International Conference is where challenges are explored, solutions are uncovered, and opportunities are developed, making it the largest and most highly respected event solely dedicated to biopharmaceutical manufacturing. Save time and reduce cost of goods with tips on streamlining processes and implementing novel technologies. Find new collaborators and partners with superior networking opportunities at the industry’s largest event devoted solely to biopharmaceutical production. Consult with >150 providers of novel and practical services and products in the exhibit hall.…

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…

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…

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…

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…

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.…

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…