People who regularly culture animal cells become so comfortable with standard techniques that novel approaches can seem contrived or even unnatural. However, the typical cycle of seeding cells at very low density in an excess of medium and harvesting (often quite aggressively) just before the point of medium exhaustion is quite an unphysiologic process. Popular culture systems often take cells that originally grew attached to a porous matrix at high densities, with little variability in nutrient and oxygen supply, and…
Search Results for: antibody characterization
Biopharmaceutical Product Development
Catalent Pharma Solutions offers a total solution for the development and manufacture of biopharmaceutical and sterile products. Our proprietary technology — and expertise in working with proteins, peptides, and other biotechnology-derived active materials and small molecules — helps maximize the potential of your API and accelerate your product’s speed to market. From cell line engineering to manufacture of API and drug product for clinical trials, our team of highly experienced protein chemists, biochemists, pharmacists, and pharmaceutical scientists provides the exceptional…
Setting the Stage
Much has already been written lately about addressing the so-called “downstream bottleneck(s).” A number of companies are leading the way toward developing products and platforms for reducing both the costs and the time required for downstream processing. Our task with this special issue was to provide a state-of-the-art update on these activities — but as always, within a limited number of pages allotted. The primary issue behind this bottleneck debacle is to address purification challenges posed by aggregation in cell…
Applying Intelligent Flow Microscopy to Biotechnology
Ongoing requirements for additional insight and CGMP-compliant measurement have led to interest in new technologies that can be applied to the analysis of many different types of particle-containing fluids. Micro-Flow imaging (MFI) is a robust, versatile, and intelligent vision technology that is increasingly used for evaluating populations of microparticles encountered during bioformulation development (1). It is also being accepted in fill–finish processes and many other biotechnology applications. Features of MFI technology that have contributed to its rising popularity include the…
Global Marketplace
Depth-Filtration Platform Product: Stax disposable depth filter platform Application: Downstream processing Features: Simplicity, intuitive operation, safety, and speed improve the efficiency of depth filtration processes. A stack of single-use depth filter capsules are configured in an ergonomic, vertical design to enable a single operator to load, operate, and unload within a reduced footprint. Single-use capsules eliminate the need for cleaning and associated validation. Interlocking modules are interchangeable and scalable. Contact Pall Life Sciences stax@pall.com Clean-in-Place (CIP) Product: RotaCIP cleaning equipment…
Environmental Life-Cycle Assessment of Disposable Bioreactors
Disposable technology for bioprocessing is efficient and cost effective in many product development scenarios. For an industry dedicated to improving human health, however, the environmental contributions of a product must also influence its bottom line. Product transitions evaluated within a people/planet/profit framework require assessment regarding shifts in human and environmental impact. Life-cycle assessment (LCA) offers one perspective by evaluating the environmental loading of inputs and outputs to a product or process. The contribution of individual product life-cycle stages…
21st Century Vaccine Manufacturing
Establishment of standard production platforms can help vaccine development move a step closer to the commercial, technical, and regulatory benefits increasingly enjoyed by developers of monoclonal antibody (MAb) products. Three recent advances especially will assist vaccine manufacturing development: rapid analytical methods to support evaluation of process design and provide in-process control; and the establishment of supply chains and vendors across Asia for bioprocessing equipment and consumables that meet the highest international standards. Whereas some workers in the field may consider…
IBC’s Fourth Annual BioProcess International Analytical and Quality Summit
The fourth annual BioProcess International Analytical and Quality Summit offers a focused look at solutions and approaches to problems facing analytical scientists in product characterization, assay development, method validation and quality control. Separate conference tracks are dedicated to biophysical analysis, posttranslational modifications, and method validation — with an additional track to tie those fields to the need for improved product understanding associated with quality by design. This multitrack format allows you to customize your conference experience based on your personal…
TIDES
For 2009, TIDES renews its focus on science. The agenda was put together by leaders in oligonucleotide and peptide development and manufacturing. The result is a program with novel, in-depth scientific data in each presentation. The agenda once again includes comprehensive coverage of drug candidates in development; new strategies for formulation and delivery; and the latest in regulatory updates, quality initiatives, process and analytical development, and manufacturing. This allows you the opportunity to benchmark your progress against that of your…
MAb Contaminant Removal with a Multimodal Anion Exchanger
Monoclonal antibodies (MAbs) constitute ∼30% of the biopharmaceutical products currently under development (1). An increasing demand for MAbs during the past decade has led to intense development of high-expression cell cultures (2). Today, it is possible to see titers of 4–5 g/L, and expression levels as high as 15 g/L and greater have been reported. As a consequence, demand has increased for more efficient downstream processes. That demand, combined with its potential for reducing time-to-market, has increased interest in the…