Figure 1. The demand for biopharmaceutical products is increasing rapidly; however, development timelines of about 12 years leave little time for return on investment before a patent expires. Fast process development is therefore crucial to speed up the market entrance of new biopharmaceuticals. Until recently, chromatographic process development was restricted to a sequential regime. However, new innovative methods have been developed to perform up to 96 parallel chromatographic experiments on a Tecan Freedom EVO® robotic workstation (pictured, right), allowing for…

Biopharmaceutical manufacturers face increased pressure to commercialize new drugs faster and at a lower cost. As a result, production demand is outpacing available manufacturing capacity. To meet existing and future demand and maintain a competitive advantage, many manufacturers are striving to develop increased efficiencies within their manufacturing processes. This is where single-use systems — particularly single-use transfer lines — can deliver significant value, including added flexibility, improved production yields, and increased cost savings. The trend today is toward transfer lines…

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. 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…

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…

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…

Cell counting and viability assessment are routine but essential parts of bioprocessing procedures, and accuracy, reproducibility, and standardization are essential to successful outcomes. Traditional methods produce variable results because they rely on subjective discrimination of dye-stained cells using a hemacytometer and microscope. Substantial operator-to-operator variability in the cell counts is common, even when one researcher examines the same sample twice. Guava technologies offers a solution: a simple, accurate, and reproducible absolute cell counting and viability assay that overcomes many of…

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…

Figure 1. CellPrime rTransferrin recombinant human transferrin provides an animal-free alternative to iron salts for industrial cell culture. It is a recombinant analogue of human transferrin expressed in Saccharomyces cerevisiae. Supplied as a human holo-transferrin analogue, CellPrime rTransferrin binds specifically to the transferrin receptor, thereby facilitating iron uptake into cells for optimal cell culture performance. Here we describe cell culture data demonstrating that CellPrime rTransferrin shows equivalence to human transferrin (hTf) and superiority to bovine transferrin (bTf) in stimulating cell…

Figure 1. This study describes a simple procedure for improving insect cell yields in a benchtop cell culture bioreactor. Here, yields of Spodoptera frugiperda (Sf-9) cells were increased by nearly 29% through monitoring dissolved carbon dioxide (dCO2) levels in the culture and adding air to the vessel headspace to reduce dCO2. The method can also be used to maximize yields in a wide range of mammalian cell types. Introduction Producing high yields of protein from insect cells usually requires maintaining…