July 2008

First Biomass Monitor Integrated into Applikon Biotechnology’s Bioreactor Control System

Applikon Biotechnology BV (in the Netherlands) and Aber Instruments Ltd. (in the United Kingdom) have entered into an agreement for the exclusive supply of the first integrated bioreactor controller and sensor for viable cells on the market. Applikon Biotechnology will offer the viable cell sensor and controller option in its EZ Control bioprocess controller portfolio designed for the biotechnological and biopharmaceutical industries. The Aber Biomass Monitor uses a unique in situ probe that incorporates four annular ring electrodes to apply…

An Easy Method for Increasing Cell Yields of Insect Cells in a Benchtop Bioreactor

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…

Scale Up on Efficiency in Biologics Contract Manufacturing

Wacker Biotech has a 20-year track record in manufacturing microbial-derived biopharmaceuticals, giving us a deep understanding of such products and of our customers’ needs. We provide comprehensive contract-manufacturing services and proprietary technologies that significantly lower the cost of goods. Our customers benefit from a comprehensive service for the development of robust, highly efficient, and readily scalable processes and GMP-compliant manufacturing for clinical trials and commercial supply. Service We work in close collaboration with our customers. Projects are managed by dedicated…

Next-Generation Tools in Program Management for CMOs

Figure 1. Effectively working with a contract manufacturer’s project management team to ensure project success is a key goal for not only Althea Technologies, but for all companies working on difficult and complex manufacturing projects. Project management tools are widely used to effectively manage biotechnology and pharmaceutical product development. Implementing a project management office (PMO) is still a challenging undertaking for a contract manufacturing organization that has a wide array of project requirements to address. There are a number of…

A Biotechnology Powerhouse That’s Always Thinking Ahead

Figure 1. AmProtein Corporation is a biotechnology powerhouse that has revolutionized the biologics industry with the discovery of a novel expression vector and development of a disposable bioreactor series. AmProtein has used these two discoveries to develop an unbelievably simple and efficient, industrialized CHO cell protein production platform. This platform includes a revolutionary expression vector; a single-use, plastic bag-based bioreactor system based on a novel, patented O2 transfer method; and serum-free cell culture media. The platform is scalable from bench…

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…

Taking the Next Step with Contract Manufacturers

Pressure is bearing down on all sides. Pharmaceutical and biotechnology companies face stress from increasing costs, intensifying global competition, growing regulatory stringency, and more. For years, pharmaceutical and biotechnology companies have relieved a little of that pressure by outsourcing functions to a limited extent, such as in packaging or distribution. Allowing a contract manufacturer to perform some of these operations frees up companies to focus on their core competencies. Today, however, some of the industry’s most eye-opening success stories are…

Avecia Biologics: Development Expertise. Manufacturing Excellence.

Avecia’s industry-leading expertise enables customers to improve the cost-effectiveness and profitability of new therapies, while maintaining fast-track progress into, and through, their clinical development programme. Process Development and Scale Up Avecia’s experience ensures that process development is applied appropriately dependent upon the development needs of customer products at different clinical stages. Expression in E. coli and yeast, including Pichia pastoris and Saccharomyces cervisiae Wide range of constructs and expression options including developing a customer’s existing system or creating one de-novo…

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…

PACE™ Cell Technology

Figure 1. The costs of producing monoclonal antibodies (MAbs) from mammalian cells are extremely high. Producing 500 kg/year of a MAb can run $200,000,000/year or more. Great effort has been made by the biopharmaceutical industry to reduce these costs. Companies have improved or expanded their existing infrastructures for MAb manufacturing, optimized media formulations and feeds, and/or genetically engineered production cell lines, with the current industry goal of 10 g/L titers and productivities of 100 picograms/cell/day. A twofold increase in volumetric…