August 2012

Connect. Grow. Succeed.

Rentschler Biotechnologie GmbH is a global, full-service contract manufacturer with over 35 years of experience in the development, production, and approval of biopharmaceuticals in compliance with international GMP standards (EMA/FDA). 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 L, 1,000 L, and 2,500…

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…

Optimizing Your Media

    Figure 1: ()   For more than 65 years, Kerry’s Sheffield brand has earned its reputation for reliability and excellence in serving the biotech, pharmaceutical, and nutrition markets. We deliver innovative, animal-component–free supplements to assist customers increase cell proliferation, extend cell viability, and increase target protein production. Every day we expand our capabilities to meet the changing needs of the biotech market by providing the industry’s most innovative and extensive biotechnologies, including complete supplement systems, hydrolyzed proteins, recombinant…

High-Performance for Large-Scale Products

      Recent advances in the research of therapeutic biologics have resulted in increased market demand for novel manufacturing systems to help meet the growing production need. Recent data resulting from increased research into the human immune system has resulted in the development of innovative treatments for a number of diseases with large unmet need both as vaccination and therapy. To compliment this growth, new approaches in pharmaceutical manufacturing help to fill complex biological products, not only to secure…

BioXcellence BI-HEX® Mammalian Expression Platform

    Figure 1: ()   The production of therapeutic proteins like monoclonal antibodies (MAbs) and bispecifics depends on mammalian expression due to the posttranslational modifications occurring in these molecules. At Boehringer-Ingelheims (BIs) BioXcellence unit, we use the BI-HEX™ mammalian expression platform for fast and cost-efficient development of high-titered manufacturing processes. The BI-HEX™ platform is composed of the following interlinked elements: BI’s proprietary vector system, the BI-HEX™ cell lines, which are derived from the CHO-DG44 cell line (1), a short…