SynCo Bio Partners believe that contract manufacturing should not be “one size fits all” and that the biopharmaceutical contract manufacturing industry needs to explore different collaborative business models in the development of production processes with prospective clients. Most CMOs, including SynCo, offer complete, full process, and analytical method development from the upstream fermentation/cell culture stages to the final purification steps. For small virtual companies to larger organizations with limited available internal resources this can be a good…

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, they have relieved a little of this pressure by outsourcing functions to a limited extent, such as packaging or distribution. Allowing a contract manufacturer to perform some operations frees up companies to focus on their core competencies. Today, however, some of the industry’s most eye-opening success stories are the result of even more extensive…

Asahi Kasei Medical Co., Ltd. is pleased to announce the commercial launch of Planova™ BioEX, its new generation of hollow-fiber membrane virus filters. Planova™ BioEX filters are specifically designed to meet the urgent need in downstream biopharmaceutical processing for robust virus filters that not only enhance safety, but also have higher filtration capacities and shorter processing times, even under demanding filtration conditions such as high protein concentration and high filtration pressure. Developed using Asahi Kasei Medical’s unique technology base in…

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…

    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…

      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…

Figure 1: Production of biopharmaceuticals has over recent years evolved from simple scale-up of lab-based techniques into a much more engineering-driven task. The entire industry has matured. Safety and efficiency are key drivers in this new era. Large and increasing production volumes of biopharmaceuticals create a need for further development of chromatographic stationary phases. The main focus of resin development has been to increase productivity, which can be achieved by a combination of improved pressure-flow resistance along with increasing the…

Buffer preparation and distribution are among the most common unit operations in biotherapeutic production. Despite the sheer volume of buffer consumed in bioprocessing and the importance of buffers in nearly every process step (e.g., cell growth, chromatographic separation, final formulation), buffers generally receive less attention from process development and process improvement teams than more challenging areas such as media preparation or active pharmaceutical ingredient (API) production. As one researcher stated, “buffer preparation is not valued as a strategic core competence…

Figure 1: The recent successful production and application of new therapeutic antibodies has increased the demand to develop the next generation of antibodies. The race to develop new antibodies requires excellence in process development and full-scale production. Following the discovery phase, potential drug targets are taken from early clinical phases to market approval. During this process, efficient screening tools are important for the exploration of the experimental design space — in line with US FDA quality by design (QbD) initiatives…

For over 50-years, W. L. Gore & Associates has earned its reputation for providing innovative, high-value products such as GORE-TEX® outerwear, Elixir® guitar strings, and GORE-TEX® vascular grafts. As the company invented expanded polytetrafluoroethylene (ePTFE), Gore offers an unparalleled level of technical knowledge and experience with this versatile material. This know-how starts with a deep scientific understanding of fluoropolymers, particularly PTFE processing and fluoropolymer development. Gore’s unique technical agility enables the development of a wide range of processes, products, and…