2011

Global Marketplace

  High-Throughput Osmometry   Product: Advanced 20G osmometer Applications: Cell culture process development and optimization Features: New approaches to accelerate cell culture process development and optimization require higher sample throughput for osmolality testing. The Advanced 20G high-throughput osmometer was developed by combining state-of-the-art osmometry technology and robotics within a parallel sample processing scheme. Samples can be analyzed in 96-well format within 35 minutes, with the same accuracy as provided by stand-alone osmometers. This system has been applied to support osmolality…

IBC’s 28th Annual Antibody Development and Prodution

Antibody Development and Production covers the entire spectrum of topics related to development and production of the most promising therapeutics in the biopharmaceutical industry. An estimated 30% of new drug products likely to be licensed in the next decade will be antibodies. With the reality of their biosimilar equivalents getting closer, companies need to develop processes faster to preserve their time on the market free from generic competition and keep costs down. With that in mind, we developed the 2012…

Clinical Development of Biosimilars

    Biosimilars require comparative studies that are different from the typical placebo-control clinical trials for first-generation proteins. A typical clinical trial programs must show equivalence of a biosimilar to the originator protein. Hans-Peter Guler, senior vice president of clinical development at INC Research, recently discussed with me the primary objectives and approaches to conducting an equivalence design.   By contrast with trials for originator proteins, equivalence trials require a different statistical approach. The biosimilars company needs agreement from the…

IBC’s Fourth Annual AsiaTIDES

The AsiaTIDES conference is a unique opportunity to update your knowledge of the latest research and manufacturing technologies for oligonucleotide-and peptide-based therapeutics and access this rapidly growing market area. Hear the latest reports from around the world — a program agenda not available at any other event in Japan — at a convenient forum in Tokyo. This event continues to be the premier forum to get a comprehensive update, meet key players, and increase your knowledge of the oligonucleotide-and peptide-based…

Toward Defined Culture Conditions for Pluripotent Stem Cells, Part 2

    At the UK National Stem Cell Network ‘s annual meeting in York, UK on 31 March 2011, a workshop organized by STEMCELL Technologies workshop addressed defined media for human stem cell culture. As illustrated in Part 1 (October 2011), it is critical to understand the pathways that maintain genetic stability during hES self-renewal, which is a prerequisite for all clinical applications. Because physiological DNA damage can take place during normal cellular proliferation, and accumulation of unrepaired DNA could…

From The Editor

      In one company I worked for, we were all given a year to participate in a project called “Budget Busters.” Each person and department was tasked with figuring out ways to save operating costs on all levels. Monthly cash awards were given to those who had made significant contributions to the program. Our mailroom manager created notepads for us from scrap paper. We began reusing manila folders, and our editorial department began using both sides of manuscript-tracking…

How QbD and the FDA Process Validation Guidance Affect Product Development and Operations, Part 1

    Earlier this year, the FDA issued its long-awaited process validation guidance document, which had been several years in development. It is well written and effectively articulates what many progressive companies have been thinking and doing for years. But many people in the industry are asking questions: How will it affect our process development programs? How will it affect the submissions and licensure of our products? And how will it aid in our commercial operations? Or will it have…

Trends in Perfusion Bioreactors

    Single-use bioprocessing equipment has come to thoroughly dominate precommercial biopharmaceutical production in only a decade. Yet even with this breakthrough, performance and cost pressures on biopharmaceutical facilities continue to grow. Demands for greater productivity, more efficiency, and lower costs are resulting in an unrelenting push for upstream improvements. Some people in the industry are predicting that perfusion bioreactor technologies may be the next revolution in bioprocessing (1). Perfusion may possibly become a dominant single-use bioreactor technology, with fed-batch…

Sustainability in Bioprocessing

    The concept of sustainability has evolved over the past few decades to describe conditions for harmonious coexistence of industry and nature while meeting socioeconomic requirements of present and future generations. For this environmentally focused report, I like the simple definition offered by Armstrong International, a provider of steam, air, and hot water systems that improve utility performance, lower energy consumption, and reduce environmental emissions. According to a brochure that in part describes its work with Pfizer, Armstrong defines…

Analysis and Immunogenic Potential of Aggregates and Particles

    The number of biotherapeutics on the market has rapidly increased during the past several years. Such proteins commonly exhibit a concentration-dependent propensity for self-association, which often leads to the formation of aggregates that range in size from nanometers (oligomers) to microns (subvisible and visible particles). Publications two years ago focused attention on the potential immunogenicity of active-ingredient aggregates ((1,2,3,4). The authors discussed lack of specificity of compendial measurements and inability of other current methods to address potential effects…