2012

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…

ALLpaQ

      At ALLpaQ, we’ve enjoyed 12 busy months designing and supplying folding plastic bioprocess containers to the pharmaceutical and biotechnology industries. Thinking outside the proverbial bioprocess box, we’ve also responded to customer demand by growing our consultancy arm. This means we can design your organization’s whole containment needs from start to finish, saving you time and money along the way.   Our Knowledge Is Your Power   With 10 years’ experience developing the preeminent range of plastic large-volume…

Scale Up on Efficiency in Biologics Contract Manufacturing

      Wacker Biotech is a dedicated contract manufacturer of biopharmaceuticals with more than 20 years of experience in microbial systems. We offer proprietary technologies (ESETEC®, DENSETEC®) that significantly lower the cost of goods. Our customers benefit from a comprehensive service for the development of robust and highly efficient processes and GMP-compliant manufacturing for clinical trials and commercial supply. We opened recently a new process-development unit to optimize the entire process-development chain, from gene to purified protein. A second…

Scalability of Mobius® CellReady Stirred-Tank Bioreactors

      EMD Millipore has developed a family of single-use bioprocess containers designed for mammalian cell growth and recombinant protein production. The Mobius® CellReady product offering includes bench-scale (3-L), small-scale (50-L) and pilot-scale (200-L) bioreactors spanning early process development through clinical batch production. To enable the successful scale-up of a biomanufacturing process, a number of factors critical to efficient cell growth, viability, and protein production were considered and used to develop an optimized design. These include mixing efficiency, gas…

SoloHill Microcarriers in a 25-L PadReactor™ Single-Use Bioreactor

        The purpose of this study was to demonstrate compatibility and performance of SoloHill’s Collagen-coated microcarriers in ATMI Lifesciences’ Integrity™ PadReactor™ system. The solid polystyrene core of the collagen microcarriers prevents absorption of serum or cell products into the core of the microcarrier, and the 1.03 specific gravity and 125- to 212-μm diameter allows them to be maintained in suspension with gentle low stirring speed. These solid microcarriers provide an excellent substrate for cell growth. They can…