2008

In Line Buffer Dilution

Biopharmaceutical companies continue to wrestle with how to approach the implementation of process analytical technology (PAT). The accelerated adoption of many new technologies has benefited from the identification of a “killer app,” an early application that enables a readily achieved breakthrough in capability. This can be a totally new capability (e.g., e-mail on the internet) or a major step-change (e.g., 10× or more) in an existing capability. Flashes of inspiration cannot be achieved at will, but we can identify elements…

Single-Use Containers Demand Single-Use Sensors

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…

A Platform for Purifying Pharmaceutical-Grade Plasmid DNA Using CIM® Monolithic Columns

Figure 1. CIM Convective interaction Media® are monolithic chromatographic supports used for purification of plasmid DNA, viruses, and other large biomolecules on a laboratory and industrial scale. CIM® monoliths are characterized by large flow-through channels (average diameter of 1,500 nm), which enhance the mass transfer between the mobile and stationary phase. This results in a high and flow-independent dynamic binding capacity and resolution. For plasmid DNA purification on an industrial level, these characteristics increase productivity, making CIM® monolithic columns attractive…

Biopharmaceutical Product Development

Catalent Pharma Solutions offers a total solution for the development and manufacture of biopharmaceutical and sterile products. Our proprietary technology — and expertise in working with proteins, peptides and other biotechnology-derived active materials and small molecules — helps to maximize the potential of your API and accelerate your product’s speed to market. From cell line engineering to manufacture of API and Drug Product for clinical trials, our team of highly experienced protein chemists, biochemists, pharmacists and pharmaceutical scientists provide the…

Holistic Solutions Available As Single Parts

Bioengineering AG has 30 years of experience in the construction of hygienic plants. Thereby holistic process equipment from the feed line to the valve system for the final cleaning has become the status quo. Our new BioAccessories department focuses on all our components and accessories. Now you do not need a Bioengineering system to be able to use our developments. For special applications we offer the possibility of custom-made or even newly developed parts. Safety with Leak-Proof Couplings: Sterility begins…

Preparative Peptide Purification

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…

Accurate and Rapid IgG Titer Determination for Clone Selection and Bioprocess Development

Figure 1. Accurate and rapid IgG titer determination is critical in the selection of cell lines and culture development for antibody production. ForteBio’s Octet QK and Octet RED Systems provide rapid and accurate IgG quantitation in a label-free format that is easy to use. The Octet family of instruments offers analytical capabilities that provide greater value in applications where existing methods such as HPLC and ELISA have limitations in throughput, performance, workflow, and ease of use. Principle Different protein concentrations…

CMC Continues to Grow

With expansion of production capacity, range of services, and customer base, CMC continues to grow. Earlier this year, CMC acquired the former ICOS Biologics development and manufacturing facility in Seattle, WA, from Eli Lilly. Now known as CMC ICOS Biologics, this facility focuses primarily on mammalian production, and during 2008 it is being upgraded to enable production of in-market biopharmaceuticals as well as late-stage clinical trial material. Dr. Gustavo Mahler, previously with Bayer Healthcare, has been appointed president of CMC…

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…

Single-Use Technology for Aseptic Filling

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…