August 2012

Development of a High Capacity, Mixed-Mode Resin for High Conductivity MAb Feedstocks

      Cation exchange resins are used in many protein purifications. The high capacity of these resins is very important to process throughput particularly as protein expression levels reach titers >10 g/L. In many cases the feedstock may need to be diluted before loading onto a cation exchange resin to maintain the high protein dynamic binding capacity (DBC) reported by the manufacturer. The additional water, buffer volumes, and process time add cost to the loading step. Tosoh Bioscience is…

Biopharmaceutical Development and GMP Manufacturing

      Richter-Helm has more than 25 years of experience in the development and good manufacturing practice (GMP)–compliant production of a wide range of biopharmaceuticals, including recombinant proteins (e.g., cytokines, growth factors, antibody fragments, surface antigens) plasmid DNA microbial vaccines (e.g., attenuated whole cell vaccines).   Customized Solutions   Richter-Helm offers customized solutions for all steps in biopharmaceutical projects through contract development and manufacturing services featuring GMP state-of-the-art facilities for microbial production fermentor scale up to 1,500 L strong…

Safety in Single-Use Systems

      Single-use technologies are a growing market and becoming increasingly common in biopharmaceutical manufacturing. Because of this growth and their increasing use in further reaches of upstream and downstream processes, understanding the safety and sanitation of single-use technology is vital. One of the key benefits of single-use systems is their potential to eliminate cross-contamination during pharmaceutical manufacturing. In processes that are entirely single-use, replacement of the fluid path assembly during production eliminates the concern for contamination in any…

Grade, Range, and Format

      In pharmaceutical and biochemical manufacturing processes, the emphasis is on knowable quality levels, defined components, and predictable, repeatable yields and products. This underlines the importance of reliable specification and quality claims, whether they point to cGMP, molecular biology grade, high purity, or simpler grades. The point is to be what they are claimed to be. Naturally, it is not a question of the highest purity possible, but rather the highest purity necessary at a cost that makes…

Sandoz: Provider of Customized Solutions in Biotech Manufacturing

      Sandoz is one of the leading specialists in biotech development and manufacturing. Comprehensive know-how is based on more than two decades in microbial and mammalian cell culture production at commercial scale. Today Sandoz offers a broad variety of integrated services including innovative expression systems, process development, scale-up, and production of recombinant products derived from microbial systems and mammalian cell culture in state-of-the-art facilities. Our expertise is based on numerous projects successfully performed in collaboration with our customers.…

Insect Cell Cultivation in Orbitally Shaken Flasks with Sensors

Figure 1: () The utility of insect cells for protein production has been described in several reviews. Grown in batch mode, production cell lines Sf-9, Sf-21, and BTI-TN-5B1-4 can reach high cell densities (>1 × 107 cells/mL) in an optimized culture medium. Alow-shear cultivation system that guarantees sufficient oxygen supply is also required. The kL a parameter is used to characterize oxygen transfer in a cultivation system. The 250-mL shaken flasks used in this study were coupled to a Shake…