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 sheets and other forms. We collected all our stashed flocks of paperclips, prides of sticky notes, herds of rubber bands, and gaggles of ink pens, and restocked the supply cabinets with them — reducing supply costs significantly. We learned how recycling saved us money in waste-disposal, and we developed ways to spend less on business travel. The thermostats were reprogrammed to remain within the realm of comfort, but not to heat or cool the building overmuch over weekends. And we learned to turn out lights when they were not needed.
We all ...
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 no effect?
Consider what the document says. In the simplest terms, it articulates four main messages. A strong process development program is essential — preferably using quality by design (QbD) — to eventually obtain expedited product approval and benefit from a relaxed regulatory position with the agency. Process validation (PV) is linked into that activity in verifying its conclusions: a set of team-based activities requiring many disciplines to work together to be effective. PV is value added and never stops. It requir...
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 systems taking the position as a well-proven but legacy technology. As the technology evolves, researchers are finding that perfusion may offer a number of cost and performance advantages.
Figure 1:
The Z RP perfusion bioreactor system from ZellWerk GmbH(GMP breeder, bioreactor, control unit, operation software) ()
Data from the 2011 8
th
Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Producti...
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 this concept as “meeting the needs of current generations without compromising the needs of future generations.”
In theory, that may imply an “either–or” situation: That is, either a facility/process is sustainable, or it isn’t. (And you could argue, then, that nothing truly is.) But in practice, moving from an unsustainable past toward a sustainable future in business is more of a continuum as companies take steps toward more environmental responsibility over...
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 of large protein aggregates on the safety and efficacy of therapeutics. Discussions between regulators and industry have led to development of novel techniques to detect and characterize aggregates and increased research into the role of protein aggregates of all sizes in immunogenicity. In addition, the pharmacopoeias have been revising monographs to improve subvisible-particle testing of biotherapeutics and clarify ter...
+6Analyzing 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) to characterize charge variants. iCIEF has contributed significantly to biopharmaceutical development with its high resolution, minimal development time, reduced sample volume, and fast run times
1
,
2
,
3
,. Those benefits allow for applications across entire pharmaceutical processes, from cell culture development and optimization to commercial quality control (QC) rel...
+1 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) for a target product include
Chromatographic media is the center of downstream purification in the biopharmaceutical manufacturing process and therefore is a critical raw material for achieving a consistent process and producing a high-quality product. For certain processes, traditional ion exchangers often require tight control of critical process parameters such as conductivity and pH (
8
). Lot-to-lot consistency of chromato...
+1 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 of fitting and tubing options. Made of pharmaceutical-grade TepoFlex film, they are available in 500-mL to 6-L volumes.
Contact
Meissner Filtration Products, Inc.
www.meissner.com
Disconnecting Disposables
Product:
Clipster aseptic disconnector
Applications:
Aseptic disconnection of single-use assemblies
Features:
The Clipster aseptic disconnector from Sartorius Stedim Biotech is a disposable device for disconnecting single-use transfe...
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 therapeutics fields. It is the only event in Asia with comprehensive updates on therapeutics in development from major big pharma, biotech, and academic players worldwide. At AsiaTIDES, build basic knowledge, learn about the latest applications, build your collaborative network, and learn skills to move your projects forward in one of today’s hottest research areas.
New This Year
Two new preconference tutorials will be offered:
More Representation from Big Pharma:
The 2012 faculty list ...
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 encourage hESC transformation, it is imperative to undertake high-resolution SNP analysis when studying genetic stability. Furthermore, most hESCs exhibit normal karyotypes after long-term culture, so high-resolution DNA analysis can identify copy-number variations
5
,. And culture-associated genetic aberrations are more likely due to suboptimal culture conditions that select and amplify mutated cells with growth and survival advantages than to an intrinsic property of hESCs.
On Differentiation
Su...
