July 2009

Boehringer Ingelheim: From Mind to Market

      The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and 41,300 employees. Since its foundation in 1885, the family-owned company has been committed to researching, developing, manufacturing, and marketing innovative products of high therapeutic value for human and veterinary medicine. Our therapeutic areas are respiratory, cardiovascular, central nervous system, urology, virology, rheumatology, metabolism, immunology, and oncology. Boehringer Ingelheim is one…

PAT–Based In–Line Buffer Dilution

Figure 1: Process Analytical Technology (PAT)–based in-line buffer dilution (IBD™) systems produce either binary or ternary blends with tight adaptive control. Up to 100× concentrates are diluted to meet the final dilution end product (1×) specifications. The conductivity of the diluted end product can be controlled to within ±0.1% of the upper limit of the user-defined conductivity range of the detector, and to ±0.1 pH units. Two experiments that were designed and performed to illustrate this blending accuracy are discussed…

ASI Encompasses the Complete Single-Use System

Advanced Scientifics is a leader in the design and manufacturing of single-use systems for the pharmaceutical and biotechnology industries. The company offers a multitude of solutions for flexible containers. Numerous films are available such as polyethylene (PE) and ethyl vinyl acetate (EVA) bags, as well as C-Flex, Silicone, PVC, and PharMed BPT tubing types. With sizes ranging from 50 mL to 2,500 L, Advanced Scientifics can produce single-use containers of nearly any configuration as well as multiple porting options with…

Three Ways to Increase Laboratory Efficiency

Equipment automation is the key to the emerging needs of laboratory efficiency. Automation reduces the risk of manual mistakes, minimizes experimental repetitions, and saves material. This retains lower operation costs, increases efficiency, and eases factorial-designed experiment approaches, such as design of experiments (DoE). Automated laboratory processes combined with comprehensive data management programs open the way into laboratory- and site-spanning information networks. With its Parallel Bioreactor System, DASGIP supports laboratory automation in microbiology and cell culture: It offers excellent opportunities for…

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 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 provides the exceptional…

Fast and Robust Purification Platform for Influenza Vaccines Production Based on CIM® Monolith Technology

    Figure 1:   Due to potentially very dangerous flu outbreaks in recent years, the need for production of influenza vaccines in sufficient quantities has been expressed. Also, the time needed from vaccine design to the market and overall process efficiency needs to be improved. This, along with drawbacks of the traditional viral vaccine production in embryonated chicken eggs, has led to the use of reverse genetic techniques and cell-culture–based virus propagation. Because existing downstream processes of virus purification…

25 Years Listening to the BioProcessing Market

Applikon Biotechnology is the world’s leading manufacturer of glass autoclavable vessels. Over 25 years ago, autoclavable vessels were sold as systems by many companies. When a large west-coast biotech company wanted a modular approach and also wanted changes in the design of the vessel, Applikon listened and complied. The glass bioreactor is now the standard of the industry and is sold in similar forms by many of Applikon’s competitors. Applikon has kept its focus on the bioreactor and anything related…

High-Throughput 96-Well Osmolality Determinations Supporting Cell Culture Process Development and Optimization

As the pharmaceutical industry focuses on developing biological drugs derived using cell culture processes, the ability to optimize the growth, health and potential yield of the cell line becomes increasingly important. Finding the optimal cell culture media is a daunting and time-consuming process due to the amount of potential media components and the unique requirements of the cell line being researched. Osmolality information is a crucial component to this research because of its close relationship between cells and media. Background…

Tuning Oxygen Transfer in Small-Scale Fermentors to Mimic Manufacturing Productivity: A Case Study

Figure 1: An appropriate fermentation scale-down model is critical to allow comparison of lab scale studies to the manufacturing case. Modeling of fermentors increases confidence that a fermentation process is scalable within the confines of available equipment and that the data acquired are an accurate representation of production fermentations. Modeling fermentation oxygen transfer between development scales of 1–100 L and production scales of 1,000–10,000 L+ has been extensively studied, and there are numerous approaches including P/V, KLa, and OUR models.…

An Innovative Disposable Depth Filtration System

      The Zeta Plus Encapsulated System is a disposable depth filtration system designed for the bioprocessing industry where upstream cell culture clarification or downstream impurity removal is required. The Zeta Plus Encapsulated System consists of two product lines: a small system that is ideal for lab-scale production or scale-up studies, and a large system designed for production-scale biomanufacturing. Each is composed of a filter holder, a set of top and bottom manifolds, and a flexible number of capsule…