Global Marketplace October 2009

Contamination Control

Product: Endosafe-PTS glucan assay

Applications: Biopharmaceutical process validation

Features: The Endosafe-PTS glucan assay is a rapid test designed to help companies validate that products are free of (1,3)-β-D glucans. Glucans contaminate cell culture fluids, yeast protein production, air quality samples, and cellulose filter preparations. Glucans can cause false positive results in LAL assays. The Endosafe-PTS glucan cartridges have a sensitivity range of 10–1,000 pg/mL, yield results in <30 minutes. They can be run on the same Charles River PTS reader used for endotoxin detection and Gram identification.

Contact Charles River www.criver.com

Single-Use Bioreactor

Product: CelliGen BLU bench-top bioreactor

Application: Mammalian/animal cell culture, research through production

Features: New Brunswick Scientific’s CelliGen BLU benchtop bioreactor combines all the advantages of single-use technology with the trusted performance, advanced process management, and true scalability of a stirred-tank design. Single-use vessels in 5.0-L and 14.0-L capacities come presterilized and ready to use out of the box. A compact control station provides integrated control of all process parameters for high–cell-density growth in research through production applications.

Contact New Brunswick Scientific www.nbsc.com/BLU

Flow and Cleanability

Product: STA-PURE sanitary gasket

Applications: Connecting process streams, fluid management

Features: GORE STA-PURE sanitary gaskets are made from 100% expanded PTFE (ePTFE). They are the only gaskets in their class to pass ASME BPE intrusion categories I and II after 500 SIP cycles, which enables unobstructed fluid flow and improved cleanability. Combining superior dimensional stability with the chemical inertness of PTFE, these ultrapure gaskets can be integrated into a number of systems, including process steams, ultrapure water, media preparation, and upstream and downstream processing.

Contact Gore www.gore.com/stapuregasket

Survey Compares IT Trends

Literature: Manufacturing IT survey

Features: Aegis Analytical Corp. offers a white paper that summarizes the key trends and implications from the findings of an industry survey and offers solutions to help biomanufacturers improve process predictability and outcomes. In collaboration with PharmaceuticalManufacturing.com the company surveyed 538 pharmaceutical and biotech manufacturing professionals to understand current trends associated with accessing and using manufacturing data. Download a complimentary copy of the white paper at www.aegiscorp.com/lifesciences_survey_signup.asp

Contact Aegis Analytical Corp. www.aegiscorp.com

CHO Feed Supplement

Product: EX-CELL CD hydrolysate fusion cell culture supplement

Applications: Mammalian cell culture

Features: This chemically defined CGMP-certified cell culture supplement is based on SAFC’s characterization of hydrolysate components. It is proven to provide cell growth and protein production capabilities equivalent to traditional undefined hydrolysate raw materials. It comes in a ready-to-use 20× liquid formulation and packaged in a 500-mL evaluation size and a 1,000-mL process development size. A dry powder version comes packaged in 100-g and 500-g sizes for pilot to production scale.

Contact SAFC Biosciences www.safcbiosciences.com

Biomolecule Quantitation

Product: Epoch system

Applications: Absorbance measurements

Features: The Epoch multivolume spectrophotometer system is designed for monochromator-based absorbance measurements in volumes ≥2 µL. An Epoch microplate spectrophotometer with Take3 multivolume plates is controlled by Gen5 software. This solution for life-science laboratories allows multiple users/assays and preserves precious nucleic acid and protein samples by using very small volumes for quantification. With a 200- to 999-nm wavelength range, this instrument is designed to facilitate performance in wavelength, end-point, kinetic, and well area scanning of 6- to 384-well microplates.

Contact BioTek www.biotek.com

Collect Airborne Viruses

Product: AirPort MD8 gelatin membrane filters

Applications: Air filtration

Features: Sartorius Stedim Biotech’s water-soluble gelatin membrane filters are suitable for collecting airborne viruses including H1N1 influenza. The AirPort MD8’s gelatin membrane filter method ensures reliable and accurate results. Organisms collected can be cultivated on a range of culture media, and the solubility of the gelatin filter opens up further applications such as combination with quick-test systems, quantitative collection of airborne viruses, and measurement of high microbe or virus concentrations.

Contact Sartorius Stedim Biotech www.sartorius-stedim.com

Osmometry Automation

Product: Advanced 2020-BIO automated osmometer

Application: Osmolality testing

Features: The 2020-BIO is designed for automated osmolality testing. With features such as remote system control, open connectivity, and bidirectional data transfer, it’s an easy fit for laboratory automation platforms. This instrument uses the industry-preferred freezing-point method for accurate osmolality determinations. It streamlines workflow and data integration.

Contact: Advanced Instruments Inc. www.aicompanies.com

Immunofluorescence

Product: HCS reagent kit

Applications: Cellular imaging

Features: The Thermo Scientific Cellomics Synaptogenesis high-content screening (HCS) reagent kit is the newest addition to the company’s range of Cellomics HCS reagent kits. This kit enables simultaneous detection of neuronal populations, neurites, presynaptic vesicles, postsynaptic puncta, and synapses using a fixed end-point assay based on immunofluorescence detection in cells grown on standard high-density microplates. The kit has been validated in cellular imaging assays for reliable and reproducible results, and it works on all HCS platforms to offer flexibility in end-user instrumentation.

Contact Thermo Fisher Scientific Inc. www.thermo.com/hcs

Cell Culture Services

Service: 50-L and 250-L orbital shaking bioreactor production

Applications: Upstream process development for biologics

Features: ExcellGene has expanded its service offerings using 250-L OrbShake bioreactors developed jointly with Sartorius Stedim Biotech and Adolf Kühner AG. These disposable bioreactors mix using orbital shaking to minimize shear forces during oxygen transfer. This is the first CMO to offer production of recombinant proteins at the 50-L and 200-L scale in such bioreactors. The combination enables fast and economical production of gram quantities of protein for preclinical testing and phase 1 studies under CGMP and non-GMP conditions.

Contact ExcellGene SA www.excellgene.com

Container/Closure

Product: SaniSure Cap2v8 system

Applications: Aseptic transfer and storage with centrifuge tubes, research to production

Features: SaniSure Cap2v8 one-piece molded caps give customers a closed system to protect product integrity and reduce contamination and product loss. These single-use systems can be configured with different tubing formulations, lengths, and unique accessories. They meet USP Class VI standards, are lot traceable, and are packaged in a certified ISO Class 7 cleanroom. They come as caps only or as full assemblies and can be gamma-irradiated.

Contact SaniSure, Inc. www.sanisure.net

Fluid Integrity

Product: Sani-Tech Ultra platinum-cured silicone tubing

Applications: Bioprocessing

Features: Manufactured and packaged in a certified clean room, Sani-Tech Ultra products are fully characterized, validated, and tested to a range of specifications, including USP Class VI, ISO 10993, and EP 3.1.9. Laser etching allows lot traceability. The tubing is fully autoclavable and sterilizable, accommodating temperatures from -80 °F to 500 °F (-62 °C to 260 °C). It comes in standard and custom hardnesses and 91 different ID/OD combinations. Options include bulk spool packaging and predelivery gamma irradiation.

Contact Saint-GobainPerformance Plastics http://biopharm.saint-gobain.com