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…

EndoTrap HD® manufactured by Hyglos GmbH (former Profos AG) is a new revolutionary tool especially designed to meet the needs of pharma and biotech industry for the efficient removal of endotoxins in biomanufacturing processes. EndoTrap® HD fulfils all requirements for industrial applications, and it can easily be integrated in/at early or late-stage purification processes of biological substances such as proteins, drugs, antibodies, or vaccines. Background Endotoxins (lipopolysaccharides, LPS) are major contaminants found in commercially available proteins or biologically active substances.…

Figure 1: Millipore Corporation’s new Viresolve Pro and Pro+ solutions are a major leap forward in virus clearance technology. As biotech manufacturers experience high titers, the evolution of process platforms and increasing focus on cost of goods, the demand for a robust high-capacity unit operation is increasing. Viresolve Pro and Pro+ solutions deliver robust parvovirus clearance, high productivity, and performance assurance. The Viresolve Pro and Pro+ solutions offer the highest level of virus clearance for the development of biopharmaceutical products.…

    Figure 1:   Millipore Corporation’s new ChromaSorb membrane adsorber uses an innovative membrane-based anion exchanger to perform robust impurity clearance at a wide range of salt concentrations. This feature enables users to improve their process economics by eliminating the downstream bottleneck of buffer tank capacity inherent with the use of other membrane adsorbers, as well as traditional resin chromatography. ChromaSorb membrane adsorber provides enhanced process flexibility and efficiency and a smaller manufacturing footprint than traditional anion resins and…

    Figure 1:   SterilEnz®-II/G connectors and SterilEnz Samplers represent a novel design improvement when compared with common fittings and fluid injection sites. This article briefly discusses the features, benefits, and technical aspects surrounding the design and integrity testing of the SterilEnz product line as well as advantages over their predecessors.   SterilEnz-II/G Flange Connectors and Samplers   Each SterilEnz-II/G connector is hermetically sealed inside a rugged overwrap pouch (Figure 1). The connector is fitted with a pre-attached, medical…

    Figure 1:   Full-length antibody biopharmaceuticals continue to capture significant market due to their validated effectiveness as specific therapeutics. However, more recently it has been recognized that full-length antibodies may not always be necessary because antibody fragments can provide opportunity for new therapeutics with less complicated, higher-yielding production processes such as Escherichia coli and yeast microbial systems. For full-length antibodies, the downstream processing is facilitated by use of protein A–based affinity adsorbents for capture and initial purification; however…