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Economy and Reproducibility: Varying Virus Spike Conditions on a Planova 20N Virus-Removal Filter

June 2, 2007

Introduction; Materials and Methods

Increasing Efficiency and Throughput with Separation and Purification

June 2, 2007

Increasing efficiency and throughput in downstream separation and purification performance is currently a major focus in the biopharmaceutical industry. Traditional TFF systems cannot be scaled in a linear fashion to meet the projected demand for fermentation and cell culture based products. NCSRT has created a patented line of filtration solutions that address the bottlenecks currently experienced as biopharmaceutical products scale up from clinical trials to blockbuster production quantities.

Providing Process Development, Flexible Manufacturing, and Analytical Services to the Global Biotech Community

June 2, 2007

Cook Pharmica LLC is a biopharmaceutical contract manufacturer of mammalian cell-culture products. Cook Pharmica's mission is to provide process development, flexible manufacturing, and analytical services to the global biotech community, enabling its partners to bring their life-saving discoveries to patients. Founded in 2004, Cook Pharmica is a privately held, wholly-owned subsidiary of Cook Incorporated.

cGMP Custom Manufacturing of Tomorrow's Medicines

June 2, 2007

Cobra Biomanufacturing is dedicated to designing robust processes that deliver high-quality preclinical and clinical biopharmaceutical products for its international life-sciences customers. From proteins and viruses to DNA and cells, Cobra offers a full range of biomanufacturing services and has established an enviable track record in cGMP manufacturing.

Very High Capacity Cation Exchange Resin

June 2, 2007

A new, very high capacity cation exchange resin* for process scale applications was developed by the researchers at Tosoh Corporation. This resin, with dynamic binding capacities approaching 145 mg/mL for IgG molecules, is the newest member of the Toyopearl product line.

Feature-Rich, Integrated Quality, and Regulatory Compliance Management Software for Biopharmaceutical Companies

June 2, 2007

Abstract: Sparta Systems' TrackWise quality and compliance management software (QMS) helps global biopharmaceutical companies reduce risk, achieve compliance, and lower costs. TrackWise streamlines processes by improving visibility, traceability, and accountability through structured workflow, escalation and reporting.

Utilizing RFID Technology to Make Filtration Processes Easier, More Reliable, and Faster

June 2, 2007

Radio frequency identification (RFID) technology is a reliable, accurate method of conveying critical information from point to point. Well established digital data transfer standards ensure complete and accurate exchange of critical data at almost instantaneous speeds. Unlike bar codes, RFID possesses larger data storage capability meaning more information is available. RFID tags are embedded in the filters which make the data available at point of use, where you need it, and inherently less susceptible to mechanical damage. Finally, RFID does not require a specific orientation to be read, eliminating the need for human intervention, thus lending itself to reliable automated processes.

Providing a Comprehensive Range of Biopharmaceutical Process Development and cGMP Manufacturing Services

June 2, 2007

Cytovance Biologics is a contract biopharmaceutical process development and cGMP manufacturing organization specializing in products derived from mammalian cell culture. Our highly experienced team of experts is committed to providing best-in-class services that help our customers move recombinant protein and antibody products rapidly and cost-effectively into and through clinical development. We employ a collaborative and flexible approach and business practices that meet the long-term needs of our customers and deliver long-term value and support.

Process Validation: Using Tolerance Intervals for Setting Process Validation Acceptance Criteria

June 1, 2007

One goal of process characterization is establishing representative performance parameter ranges that can be used to set validation acceptance criteria (VAC). Characterization studies yield varying numbers of data points from multiple experiments, and may also include data generated at different scales (e.g., bench, pilot, and commercial), which add complexity to the analysis. Many statistical approaches can be used to set ranges from large data sets. As an example, we present the statistical considerations and techniques for setting validation acceptance ranges for a chromatography step used in purifying a recombinant protein. Performance parameter data from a combined data set consisting of 67 bench, six pilot, and three full-scale runs were analyzed using the statistical analysis software JMP (SAS Institute). The combined data set was used to compute tolerance intervals, so that sources such as scale and column feed material could be properly modeled. The resulting ranges were used to establish..

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