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…
November 2011
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…
Imaged Capillary Isoelectric Focusing for Charge-Variant Analysis of Biopharmaceuticals
Analyzing charge variants of therapeutic proteins is critical for characterizing and monitoring quality attributes of antibodies. Charge variants include deamidation, formation of N-terminal pyroglutamate, aggregation, isomerization, sialylated glycans, antibody fragmentation, and glycation at the lysine residues. In some cases, such changes affect binding, biological activity, patient safety, and shelf life. The biopharmaceutical industry relies on tools such as ion-exchange chromatography (IEC), isoelectric-focusing gel electrophoresis (IEF), and capillary equivalents such as capillary isoelectric focusing (CIEF) and imaged CIEF (iCIEF)…
Understanding Chromatographic Media Ligand Density
The concept of quality by design (QbD), although not new, has presented implementation opportunities and challenges to both the bioprocessing industry and regulators (1,2,3,4). Tools such as design of experiments (DoE), cause and effect analysis, and multivariate analysis provide for systematic risk assessment and help identify critical quality attributes (CQAs) and critical process parameters (5,6,7). QbD is intended to ensure that manufacturing processes make products that meet predefined quality parameters. Key elements in defining such parameters (quality profile)…
GLOBAL MARKETPLACE
Aseptic Material Transfer Product: FlexFill single-use biocontainer transfer assembly Applications: Aseptic transfer of bottled media, sera, reagents, supplements, buffers, and microcarriers to bioreactors Features: Meissner’s FlexFill assembly is designed for applications requiring fast and dependable aseptic transfer of small liquid process volumes. Its large screw-cap port allows for rapid and convenient filling of disposable biocontainers in laminar flow hoods using a portable stainless steel FlexCessory stand. The assemblies can be customized to support a range…
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…