Figure 1. Established in 1997, integrated Genomics (IG) provides a full range of products and services to support research in microbial genomics, metabolic analysis, and engineering. Our flagship genome analysis system, ERGO™, provides a bioinformatics toolkit enabling better and faster identification of gene function and pathways across organisms, which is evident within more than 100 scientific publications in top peer-reviewed journals (www.integratedgenomics.com/igpubs.html). The ERGO in silico metabolic discovery and analysis tool set is the world’s largest commercially available database of…

Invitrogen has 45 years of experience in the cell culture business. Over this time, the Invitrogen name and reputation has made us the recognized leader in cell culture systems. In 2003, Invitrogen expanded on this tradition in innovative cell culture products through the creation of a team focused on process development, PD-Direct® BioProcess services. The PD-Direct team responds to core customer needs by offering customers comprehensive service from cell line and media development, to process optimization. Upstream Optimization Services The…

innovatis has established a technology portfolio to assist with the implementation of process analytical technology (PAT) at pharmaceutical companies focused on manufacturing biologics. PAT is a critical component in FDA’s initiative entitled, “Pharmaceutical CGMPs for the 21st Century: A Risk-Based approach,” which was announced in August 2002. This initiative is intended to support innovation and efficiency in pharmaceutical development, manufacturing and quality assurance. PAT is a system of building into processes “quality by design” (QbD), an idea that product quality…

Photo 1. Biopharmaceutical processing has been greatly improved over the past 10 years with the introduction of single-use/disposable technology. There has been a landslide of disposable products introduced in the areas of filtration, mixing, sampling, and transferring solutions aseptically. It is common to find papers and studies that detail the efficiencies that disposables offer to the biopharmaceutical market. What about aseptic filling? More importantly, what about the cost of aseptic filling? PDC aseptic Filling Systems offers an answer. The biopharmaceutical…

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…

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…

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…

Figure 1. Single-use components are finding more use in the biopharmaceutical industry. One application increasing in use is transportation of sterile liquids. There are many challenges to consider when shipping a flexible container with sterile liquids. Typical Bio-Containers used in shipping applications are constructed of multiple layers. The fluid-contact layer is typically constructed of low, linear low, or ultralow density polyethylene (LDPE, LLDPE, or ULDPE). A variety of gasbarrier layers can be used in construction of the multilayer film, and…

Improving production quality, efficiency, and yield is the objective of every commercial biotechnology process. Automation of assay tasks now routinely performed manually directly improves production bioprocesses. The US FDA supports and encourages this activity through the process analytical technology (PAT) initiative within its regulatory structure. The features and benefits of the online series of Automated Reactor Sampling (ARS-M™) systems supplied by Groton Biosystems are detailed here. Online Automatic Assays Today the most vital late-stage and production assay measurements — with…

Figure 1. Manufacture of synthetic peptides ranges from milligram to multikilogram amounts. When a peptide is a biopharmaceutical (API) candidate, the amount required will increase as it moves through clinical trials to marketed product. When developing purification methods, the required “product” API quantity and purity should be considered. Bradykinin is a physiologically and pharmacologically active peptide of the kinin family used in development of antagonists and therapies for hereditary angioedema. Here we describe two different methods of purifying a crude…