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…

  Summary   Comparison of a complete MAb purification process from a 100-L cell culture volume demonstrated a 50% reduction in process time using the ReadyToProcess platform instead of traditional process equipment. The decrease was made possible by elimination of column packing and testing, membrane wetting and rinsing, system cleaning, cleaning validation, and so on. Additionally, the ReadyToProcess run required less hardware and thus generated a smaller footprint. Both chromatography steps were run on one system using disposable, exchangeable flow…

          Influenza virus vaccines have traditionally been produced by infection of fertilized hen eggs. This labor-intensive approach requires large facilities, which has led to the development of large-scale mammalian cell culture methods for future virus vaccine production processes. The main focus of these studies was to use generic, established, and scalable techniques for industrial production of live influenza vaccines (Figure 1) and potentially also for other viruses independent of type or size. Development of three different…

          Water is a key raw material used in manufacturing products within the healthcare, pharmaceutical, and biopharmaceutical industries. Microorganisms found in these water systems are mainly stressed, slow-growing strains characterized by long incubation times (five to seven days) before growth can be detected using traditional microbiology methods such as membrane filtration or pour plates. That time required before contamination can be detected in water can cause delays in product release and extend the storage time of…

As the adoption of single-use products continues to grow at a very fast pace in the biopharmaceutical industry, customers and suppliers are becoming increasingly aware of the potential impact of these products on the net environmental footprint of operations. At Millipore, a key goal is to design and manufacture products with the lowest carbon and water footprints possible and to ensure that these products are managed in the most environmentally friendly way. Millipore’s sustainability vision calls for the company’s operations…