August 2012

Pharmaceutical Biotechnology Innovations in Manufacturing

Challenging conventional process technologies with innovation and forward-looking solutions lead to the next generation of manufacturing processes. With its biotechnology, chemistry, and fine chemistry capability, DSM has an extensive toolbox for developing the most economic and sustainable solutions for customers. DSM’s biotechnology uses microorganisms, enzymes, and mammalian cells to produce novel ingredients and improve existing food ingredients, (bio)pharmaceuticals, plastics, and chemicals. Mammalian Cell Culture–Based Manufacturing A state-of-the-art facility, located in Groningen, The Netherlands, is dedicated to the development, scale-up, and…

Sartopore® Platinum

    Figure 1: Sartopore® Platinum TwinPleat ()   Sterile filtration using 0.2-µm rated filters is a critical step in upstream and downstream biomanufacturing alike. Typical applications comprise sterile media addition into the bioreactors, cell harvest clarification post-depth filter, chromatography column protection, and final sterile filtration of purified bulk drug substance. Total throughput, flow rate, unspecific adsorption, and wettability of sterile filters can have direct impact on total cost of ownership. There have been innovative application-specific approaches in sterile filtration…

High-Throughput 96-Well Osmolality Determinations

      As the pharmaceutical industry focuses on developing biological drugs derived using cell culture processes, the ability to optimize the growth, health, and potential yield of the cell line becomes increasingly important. Finding the optimal cell culture media is a daunting and time-consuming process due to the amount of potential media components and the unique requirements of the cell line being researched. Osmolality information is a crucial component to this research because of its close relationship between cells…

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…