With Richter-Helm BioLogics and Richter-Helm BioTec, over 20 years of experience in development and manufacturing of biopharmaceuticals and the innovative strength of high-performance teams are coupled with the solid foundation of the owner companies Gedeon Richter Plc. (Hungary) and HELM AG (Germany). Preclinical to Commercial Supply Richter-Helm BioLogics offers services for development and manufacturing of biopharmaceutical products from customers in the pharmaceutical and biotechnology industries. Richter-Helm BioLogics develops and produces recombinant proteins, plasmid DNA, and vaccines in microbial systems. Richter-Helm…

          Applications of microbial fermentation technology in new therapeutics are expanding. SAFC offers unique cGMP fermentation-based manufacturing capabilities through its Jerusalem facility, including highly potent APIs and biologics. SAFC scientific teams provide a complete range of services, including process evaluation and development, optimization and scale up, technology transfer, manufacturing, analytical testing and regulatory filing to help customers bring new drugs to market faster. SAFC is finding new applications for its expertise in fermentation technology, including the…

          Sandoz is one of the leading specialists in microbial fermentation of classic and recombinant microorganisms. The company’s comprehensive know-how is based on more than six decades of experience in the field of classical microbial products and more than two decades in recombinant microbial production at commercial scale. Building on this know-how, Sandoz offers a broad variety of integrated services including innovative expression systems, process development, scale up and production of recombinant products derived from microbial…

          Vetter, a leading provider of aseptically prefilled drug delivery systems, is poised to launch a new state-of- the-art facility at the Illinois Science + Technology Park in suburban Chicago. An expansion of Vetter Development Service, the Chicago site will support preclinical through phase II development projects. The 24,000-ft2 facility includes three cleanrooms, microbiology and chemical laboratories, and administrative offices.   Early-Phase Work   Developed at the urging of Vetter’s North American clients, the Chicago site,…

  Conclusion   The removal of DNA from cell culture broths and lysates may be required to accomplish the CBER-recommended concentration of DNA impurity of About the Author Author Details Michael Wang, PhD, is a Marketing Manager Bioprocess at 3M Purification Inc., 400 Research Parkway Meriden, CT 06450-1018; 203- 238-8795; Mwang9@mmm.com. REFERENCES 1.) Dorsey, J. 1997. The Role of Charge in the Retention of DNA By Charged Cellulose-Based Depth Filters. BioPharm 10:46-49.   2.)3MPI Application Brief: DNA Removal from Bioprocess…

          Increased productivity and reduced costs continue to be the driving forces in process development. Recent advances in upstream processes have dramatically improved the productivity of cell culture fermentation. However, prolonged fermentation and high concentration of monoclonal antibodies (MAbs) at harvest may also lead to product degradation and/or aggregation. Clearing these unwanted by-products remains one of the main challenges in downstream processing of therapeutic MAbs. Media with high binding capacity for target molecules and significant resolution…

          A clear mandate has emerged throughout the industry to improve the timelines from candidate identification to phase 1 clinical trials. The goal of reducing the time to phase 1, combined with increasing titers and regulatory requirements, presents novel challenges to downstream development. To meet these challenges, Boehringer Ingelheim has developed the BI-Purification Excellence (BI-PurEx) strategy to shorten the development time to clinical trials while improving process understanding during early development phases to ensure a safe,…

          Over the past decade the adoption of single-use technologies has moved beyond upstream processes to bulk and filling applications. One example of integrating single-use systems in a final fill operation is to simplify connections to mobile stainless steel transfer tanks. These tanks are designed to transfer product from formulation suites to storage areas and ultimately to filling suites. To allow sterile connection to and from these vessels, designers traditionally add three-way valve assemblies to fill…

          Eshmunoâ„¢ is a new and unique family of ion-exchange resins that are designed specifically for highly productive downstream bioprocessing. The first member of the family, Eshmunoâ„¢ S, is a smart cation exchanger designed for fast and efficient purification of antibodies in direct capture and steps following protein A chromatography. Eshmunoâ„¢ Q is the newest family member. This smart anion-exchange resin coupled Merck KGaA’s renowned tentacle structure with the new hydrophilic polyvinyl ether base matrix. As…

Today’s antibodies are sourced from a diverse set of mammalian hosts whose isotypes have different affinities for protein A and protein G. ForteBio’s new protein G biosensor provides an “out-of-the-box” solution for direct quantitation of the mammalian immunoglobulins that do not bind to protein A. Readings can be performed in buffer, chromatography eluents, conditioned medium, and cultured lysates using a convenient 96- or 384- well microplate format. Assay parameters can be adjusted to detect concentrations from 0.05 µg/ml to 2,000…