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…

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…

Figure 1. As a leading provider of process and analytical solutions for the biotechnology and pharmaceutical industries, Applied Biosystems offers an extensive portfolio of tools to help optimize every stage of biopharmaceutical production — from characterization to purification to pharmaceutical manufacturing. These solutions provide pharmaceutical manufacturers with the tools they require to maximize throughput and yield and ensure product quality. Purification High Performance on a Large Scale: Applied Biosystems POROS Perfusion Chromatography products are today’s best-performing chromatographic media for process-scale…

Figure 1. A virus validation study is required for virus-removal filters prior to employing them in a biopharmaceutical purification process. Validation conditions are determined on a case-by-case basis by each filter user. Optimizing conditions for removal of parvovirus is important to achieve LRV = 4. However, the optimal conditions are often unclear for validation studies, because each product may behave differently. We attempt to establish optimal conditions for human IgG and show the effects of varying IgG concentration, purity of the virus…

Figure 1. Recently, purification of biomolecules, such as peptides and proteins, by process scale HPLC using reversed phase silica gel media has become increasingly important in biopharmaceutical production. DAISOGEL SP-300-C4-BIO is the newest product using this technology, a butylsilyl(C4)-modified silica gel with 30-nm pore diameter for applications involving peptides, proteins, and other large molecules. Besides selectivity, several other aspects influence the performance of chromatography in preparative processes and consequently have a crucial effect on the total process cost. Therefore, when…

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…

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…

The biopharmaceutical industry is a predominantly research-based industry that is rapidly maturing toward commercialization. As it does so, biopharma executives have to grapple with complex issues concerning process development, scale-up, and preclinical manufacture of material for toxicology studies, clinical studies, and eventually commercial sale. Selecting a suitable CMO, negotiating a robust contract, and managing on-going relations are of utmost importance to successfully securing a timely, quality supply of product. There are very different types of CMO. Some CMOs are biopharma…

Rentschler Biotechnologie GmbH is a full-service contract manufacturer with over 30 years of experience in the development, production, and approval of biopharmaceuticals in compliance with international GMP standards with a highly skilled staff of 350. As part of the Rentschler Group and headquartered in Laupheim, Germany, Rentschler is one of three leading European CMOs operating globally. Dedicated to delivering high-quality biopharmaceuticals produced in mammalian cell culture, Rentschler has nine stand-alone GMP suites with volumes of 30 L, 250 L, 500…

Trust, competence, and motivation are the major characteristics of a reliable contract manufacturer for clinical projects. At Miltenyi Biotec, customers have more than just projects: they have goals that Miltenyi Biotec helps them to achieve. Miltenyi Biotec is a midsized biotechnology company, focused on medical devices, equipment, and therapeutics for R&D and clinical applications. The product expertise includes GMP-grade antibodies, peptides, growth factors, cytokines, aphaeresis materials, and cellular products, resulting in a broad and significant understanding of different manufacturing challenges.…