Figure 1. Antibody-based drugs represent a growing segment of the pharmaceutical industry and one of the most promising classes of therapeutic drugs. The demand for protein-based drugs is expected to grow steadily for the foreseeable future. However, production of monoclonal antibody (MAb)–based drugs remains very costly, and solutions to lower production costs are needed. Downstream purification steps are becoming a target for cost reduction. The use of ion-exchange chromatography to directly capture MAbs from cell culture streams or as a…

The development of single-use bioreactor technologies is focused on bringing new designs onto the market for effective oxygen transfer and cultivation of not only cell culture processes, but also microbial cultures. The advantages of disposable technologies are: ease of use, prevention of cross-contamination, labor and capital investment savings, reduced qualification and validation, and increased flexibility. The costs of disposables are lower compared with conventional stainless-steel bioreactors because the capital investment is lower. Therefore, the need is reduced for qualification and…

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…

Photo 1. Demand for single-use bioprocess systems in the biotech and pharmaceutical industry has increased significantly in recent years. Among other reasons — such as operations, sourcing, and validation — their lower initial investment capital makes disposable systems very attractive for the pharmaceutical industry. When Wave Biotech introduced the first wave-action reactor/mixer, it was seen by some as the start of single-use technology. Once containers become single-use, all other parts of the manufacturing process ideally have to follow the same…

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…

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…

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…

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…

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…

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…