July 2008

Single-Use Solutions

The increasing popularity of “single-use” or disposable bioreactors for upstream processing can be understood by considering a typical biotechnology manufacturing facility. The infrastructure required to implement traditional glass/steel bioreactors is substantial, and the time and expense required to validate it can be significant. The requirement that both the bioreactor itself and its ingress and egress tubing use inert materials such as 316-L electropolished stainless steel results in a large capital investment and long lead times for components. In addition to…

Antibody and Protein Therapeutic Kinetic Characterization in Bioprocessing

Figure 1. There are a variety of affinity tag-protein strategies, and the use of affinity tags depends on the target protein, the expression system, and the application. The Octet QK and Octet RED systems provide an easy-to-use, label-free, high-throughput system to capture affinity-tagged biologics for quantitative or kinetic biomolecular interaction analysis. Kinetic characterization of biologics during clone selection, screening, and development is critical at all stages of therapeutic engineering and bioprocessing. Key Applications Quantitative kinetic characterization (kobs′ ka′ kd′ KD…

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.…

Optimization of a PEGylation Reaction Using Design of Experiments (DOE)

The covalent attachment of polyethylene glycol (PEG) to a therapeutic protein is frequently used to increase the half-life of that protein in patients while reducing their immunogenic response. The PEGylation reaction can be optimized to maximize the desired product (average moles of PEG per mole of protein) molecules while limiting undesired byproducts (under- and over-PEGylated species). In the example discussed here, the desired molecule was mono-PEGylated, yet the preoptimized reaction yielded multi-PEGylated species visible by SDS-PAGE. The goal of our…

Octet RED System

Figure 1. Select promising leads earlier in the development process with the Octet RED system’s rapid, highly sensitive detection and label-free analysis of small peptides and small molecules. The Octet RED system’s rapid data acquisition and high sensitivity means that even the fastest reactions and smallest binders will be easily characterized. The Octet RED system shares the advantages of the Octet QK system: BLI technology, no microfluidics, eight-channel parallel processing, walk-away automation of up to 96 samples, and affordability —…

Building a Community of Users and Expanding Novel Cell-Based Applications of the WAVE Bioreactor

Figure 1. Developed in 1996, the WAVE Bioreactor™ and Cellbag™ disposable bioreactor systems have revolutionized cell culture for commercial and R&D applications in the production of cell-derived products using animal, insect, plant, microbial, and virus cultures. Oxygen transfer and mixing are accomplished by the novel principle of wave-induced agitation. Wave action generates free surfaces for bubble-free oxygen transfer from the headspace of each Cellbag bioreactor, and it also mixes the fluid suspending cells or particles. This design eliminates the need…

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…

Expertise in Fluoropolymer Engineering Provides Unique Products for Biopharmaceutical Processing

Throughout its 50-year history, WL Gore & Associates has earned its reputation for providing innovative, high-value products such as GORE-TEX® outerwear, Elixir® guitar strings, and GORE-TEX® vascular grafts. Having invented expanded polytetrafluoroethylene (ePTFE), Gore offers an unparalleled level of technical knowledge and experience with this versatile material. This know-how starts with a deep scientific understanding of fluoropolymers, particularly PTFE processing and fluoropolymer development. Gore’s unique technical agility enables the development of a wide range of processes, products, and creative, reliable…

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…