Dr. Berthold Bodeker
Single-use technologies are changing the way how biopharmaceuticals development and production, particularly from mammalian cell culture, are being performed. Almost all process steps from cell expansion, fermentation, cell removal, purification to formulation and storage of drug substance can be done in disposables, although there are still severe limitations with single use technologies, particularly in the areas dependent on individual vendor systems, pretesting and quality control of disposables, bag and connections standardization and qualification as well as leachables and extractables validation.
Otis Johnson
The challenge of successfully developing a drug and bringing it to market cannot be overstated. In fact, only 1 in 10,000 compounds make it to markets and costs in excess of $US 1 billion in doing so [1, 2]. This figure represents a huge upfront investment that must be managed well to increase the probability of success. Increasing constraints on resources in pharmaceutical research and development, in parallel, have made it more critical to develop timely and accurate forecasts for clinical trial timelines.
Scott M. Wheelwright, PhD, Kuntal K. Sinha, Jeff Marra, Ph.D., Ken Getz, Atul Saran, John Watson
1. What, in your opinion, is currently the single largest trend with respect to strategic partnering?
SW: In my current work with a Chinese biopharmaceutical firm we see many companies that are seeking entry to the Chinese market place. These companies are primarily driven by the desire to
C. Ray Goff, Jr.
Can you assure customers their product is kept at the proper specifications from the manufacturer site to the end-user location? Is there proof?
C. Ray Goff, Jr.
Often ideas are generated but little is done on the follow-up to bring them to fruition. The purpose of this paper is to support the final stage of the Bow Tie Method- the management proposal.
David J. Snodin, Ph.D., David P. Elder, Ph.D.
This series of articles is intended to provide a general overview of the issues surrounding genotoxic impurities (GTIs) and their potential resolution. Part 1 will focus on general and regulatory aspects, part 2 will review toxicological issues, whereas part 3 addresses chemistry/ pharmaceutical considerations.
Lori Ball, Kristina Robson, Mary Rose Keller, Steve Sweeney, Jay Schiestle
The new paradigm rapidly emerging in comprehensive sample management is being driven by a powerful and unprecedented combination of scientific, economic and regulatory factors. Continuing advances in biomarker research mandate the more efficient use and management of the estimated one billion samples in storage globally.