August 2012

Managing Cell-Based Potency Assays

      Established at the forefront of current good manufacturing practice (cGMP) cell-based potency assay contract testing, Eurofins Lancaster Laboratories, Inc. provides assistance in all aspects of bioassay development, validation, method transfer, and long-term assay maintenance. Characterization of a biological product — which includes the determination of physicochemical properties, biological activity, immunochemical properties, purity, and impurities — is necessary to establish the safety and efficacy profile of a given product (as per ICH Q6B guidelines). Cell culture–based potency assays…

Increased Speed to Market with an Emphasis on Quality

Speed to market has become a key factor of success in the biopharmaceutical industry, yet it can be difficult to achieve without compromising product quality. By seeking out products that are able to provide maximum efficiency while simultaneously maintaining first-rate quality, companies can not only get to market quicker, but also gain a competitive advantage. A new bag port line, manufactured by Value Plastics (VP), both addresses these concerns and tackles them head on by incorporating them into the product…

Automated, Nondestructive, Rapid Microbial Testing

Automated, nondestructive, rapid sterility and environmental monitoring () Rapid microbial testing methods continue to gain acceptance in pharmaceutical manufacturing, but experience shows that most companies still use traditional methods for their testing. The ability to deliver results in less time than traditional methods provides compelling benefits to manufacturers. Two key areas of microbial testing where these benefits can be realized include environmental monitoring and sterility testing. Microbial testing must be completed throughout the manufacture of pharmaceuticals, including the raw materials…

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…