2011

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…

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…

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…

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…

A Brief History of Perfusion Biomanufacturing

    Today’s renewed interest in perfusion culture is due to an increased awareness of its advantages, some general improvement in equipment reliability, and a broadening of operational skills in the biomanufacturing industry. Some misperceptions persist, however, according to a 2011 review by Eric Langer (1). Our view here of the history of perfusion and fed-batch processes includes some discussion of technological process improvements and challenges that the bioprocess industry faces. A team of authors at Serono in Switzerland wrote…

Biosimilars in Development

    The 2009 Biologics Price Competition and Innovation Act (BPCIA) provided the bioprocessing industry with the legislative pathway toward approval of biosimilars. US Food and Drug Administration information regarding how it will translate that legislation, however, had been limited until an August 2011 article finally provided some insight on how those guidances might actually play out (1). As expected, the agency appears to be implementing a science-driven approach, with sponsor companies needing to apply complementary orthogonal analytical methods to…

Use of Blast Freezers in Vaccine Manufacture

    Vaccines are powerful and cost effective prophylactic tools for protecting public health. The Global Alliance for Vaccines and Immunizations (GAVI) estimates that ~5.4 million lives are saved each year by the administration of vaccines for hepatitis B, measles, haemophilus influenza type B (hib), pertussis (whooping cough), yellow fever, and polio (1). According to the World Health Organization, seasonal influenza alone claims 250,000–500,000 lives every year globally, many of which could be prevented by more widespread vaccination with the…