2008

Designed for Advanced Application

Emerging lifestyle diseases and an aging population are creating a number of major health challenges. Over the past few years, the food industry has been more focused on functional foods, those intended to be consumed within the normal diet but containing biologically active components with physiological benefits intended to reduce certain chronic diseases. This US$35 billion market has been steadily growing at 8-14% per year, as estimated by the Food and Agriculture Organization of the United States (FAO). Although the…

Batch and Fed-Batch Cell Culture

Figure 1. How well does absorbance correlate with cell density and viability measurements in batch and fed-batch cell culture? As expected in science and nature, the answer depends on a set of factors. Many people working with batch or fed-batch cell culture will reference discrete offline measures of cell activity. Total cell density (TCD), viable cell density (VCD), and percent viability can be evaluated offline using a hemocytometer and accepted trypan blue exclusion method. Cedex® and Vi-CELL™ are two examples…

Screening Loading Conditions on Capto S with a New High-Throughput Format: PreDictor Plates

Figure 1. Finding optimal conditions for a downstream purification process is critical to achieving high productivity and a robust biopharmaceutical manufacturing process at large scale. In addition, the FDA’s new Quality by design initiative may increase demands on process development work because a higher degree of process understanding must be acquired. This understanding/knowledge can be obtained if a larger experimental space is considered and/or more detailed studies are performed. The introduction of high-throughput techniques for process development partially addresses these…

A Leader in Filling Technology Services

HCM is a leader in upscale process development and aseptic filling of liquid parenterals in syringes, vials and custom containers. HCM offers clients–from newly-established firms to large-scale commercial enterprises–high quality services and innovative technologies. Quality Services Quality Services Foremost among the services HCM offers are upscale process development and aseptic filling of syringes, vials, and custom containers. In addition to traditional fill and finish, HCM offers online vacuum filling and stoppering as well as lyophilization. HCM offers customers a Stability…

Single-Use Solutions for Complex Processes

While industry is rapidly shifting from stainless steel vessels and hard-plumbed processes to single-use bioreactors and TFF filters, the transition between the multiple process steps remains complicated and time-consuming, often requiring fluid transfers, disrupting sterile barriers, and cleaning protocols. The simple solution to a complex process is connectivity: a continuous flow-path that interconnects all the process steps by means of a sterile singleuse process manifold. Spectrum Laboratories incorporates process filters, reservoir bags, flexible tubing, and other critical elements into a…

Improve Your Capability to Develop Advanced Bioprocesses with Dielectric Spectroscopy

Figure 1. On-line biomass monitoring using capacitance is now a routine task in cell culture. The capability to develop advanced bioprocesses relies on sensitive process monitoring technologies and robust process control strategies. Unlike optical technologies, capacitance is insensitive to dead cells, cells debris, gas bubbles, or other matter in suspension. With its capacitance-based sensor, FOGALE nanotech has supplied many pharma/biotech companies around the globe. The Biomass system is widely recognized as a powerful tool from process development to CGMP production…

Quality Key to Risk Mitigation

Whether applied to business security, product specification, financial exposure or personnel safety, quality is a key element underpinning any biopharmaceutical risk mitigation strategy. A quality system should not be inherently dependent upon personnel, nor should it rely solely on people to ensure the quality of the products manufactured. Irrespective of human resources, the system itself should provide consistency, addressing risk from design inception through to product delivery, ensuring that robust processes are in place that minimize risk to the product…

Developing an Economic Model for Single-Use TFF Cassettes

Figure 1. Tangential-flow filtration (TFF) cassette operations are known for reusable cassettes; however, a single-use model is less established because production-scale single-use TFF cassettes are not readily available. Novasep (through TangenX Technology Corp.) offers the first presanitized, purposely built, single-use TFF cassette for the biopharmaceutical industry. Sius™ cassettes have been designed to offer performance comparable with that of reusable products at a fraction of the cost. Each cassette arrives presanitized, ready to be equilibrated with buffer and used for processing.…

Designing, Developing, and Delivering Our Clients’ Biopharmaceuticals

Eden Biodesign is one of Europe’s leading contract biomanufacturers. We are an expert provider of consultancy, biopharmaceutical process development, and CGMP manufacturing services. Our rarely found blend of experience and expertise, gained from providing our services to more than 100 clients worldwide, ensures that the clinical medicines we develop are regulatory compliant and optimally positioned for further clinical and commercial development. Our state-of-the-art facility is licensed to produce clinical products, which we believe is best in class for its scale…

Reducing Elution Volumes with High Capacity and Improved Mass Transfer Ion Exchange Resins

Figure 1. At recent scientific conferences on downstream processing, there was much discussion about the need to reduce process volumes. Many manufacturing sites are space-limited and to take advantage of chromatographic process improvements, they must be made without the need to increase buffer and holding tankage. One significant opportunity to increase process throughput is to replace conventional with higher capacity ion exchange resins. Recently developed high capacity resins allow more protein to be loaded without the need to replace existing…