56 BioProcess International APRIL 2009 Optical Sensing Product: Visiferm DO Application: Cell culture and fermentation Features: The Visiferm DO is an optical dissolved oxygen sensor that reduces measurement time and is easier to use than classical technology. Symmetrical, heat-resistant, dual-channel optics and measurement amplifier are self-contained in a standard 12-mm format. Polarization time may be reduced from up to eight hours with traditional sensors to as little as 15 minutes. Calibration is simple because data are stored in the sensor. The sensor is also flow independent and invulnerable to interference from acidic gases. Contact Hamilton Company www.hamiltoncompany.com d F o f f clinical manufacturing through large- scale commercial production, packaging, quality control, and logistics. The packaging line represents a $3.5 million investment and took 14 months to complete. All testing and regulatory compliance was completed before the line’s January start-up. Contact IDT Biologika www.idt- biologika.com Cryopreservation Product: CryoSolve single-use CGMP cell cryopreservation media Application: Cell cryopreservation Features: These single-use syringes with Luer-lock tips help eliminate sharps, avoid cross contamination, maintain sterility, and streamline your process. Raw materials are serum-free (USP/EP) and the medium has been shown to support an average cell viability of 97%. The products are manufactured under CGMP conditions with syringes made of USP Class VI glass, compatible with DMSO. All equipment passed compatibility studies and meets the requirements of low leachables/extractables, low toxicity, and high purity. Contact Akron Biotech www.akronbiotech.com e System ign tool esign ulk tubing and sposable sets, ly and time ctor design tool ophisticated a desktop. The tool produces drawings of any bioprocessing system to specification and incudes authentic images of the components allowing a complex mixture of flow path sizes and devices. It can produce a virtual disposable system that resembles the manifold to be used. On completion of the design and approval by the user, the design can be emailed to any appropriate contractor for assembly. Contact BioPure Technology www.biopuretech.com Process Observation Literature: Line card brochure Features: L.J. Star, Inc. has updated its line card of process observation equipment designed for use in sanitary applications. It includes sight glasses, sanitary fittings, visual flow indicators, light ports, vessel camera systems, and bubble traps. The line card provides a resource for finding products that address your specific processing needs including CIP and SIP applications. The new literature describes sterile visual-flow indicators, flush-mount sight windows, high-pressure in-line sight flow indicators, and MetaClamp sanitary sight glasses. Also included is a self-draining hygienic bubble trap, the first bubble trap designed specifically for pharmaceutical applications. Contact LJ Star www.ljstar.com E. coli Expression Product: ScarabXpress Application: Protein expression Features: ScarabXpress is the latest strain in the multiple-deletion series of clean-genome E. coli. Based on the MDS42 strain, ScarabXpress T7lac contains a chromosomal copy of the T7 RNA polymerase gene expressed from a tightly controlled lac promoter. It is a K12 strain with a 15% genome reduction to remove nonessential genes, sequences for recombinogenic and mobile DNA, and cryptic virulence genes, while preserving robust growth and protein production. Genome reduction optimizes the clean genome E. coli as a biological factory, providing enhanced genetic stability and improved metabolic efficiency. Contact Scarab Genomics www.scarabgenomics.com Global Marketplace
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56 BioProcess International APRIL 2009
Optical SensingProduct: Visiferm DOApplication: Cell culture and fermentationFeatures: The Visiferm DO is an optical dissolved oxygen sensor that reduces measurement time and is easier to use than classical technology. Symmetrical, heat-resistant, dual-channel optics and measurement amplifier are self-contained in a standard 12-mm format. Polarization time may be reduced from up to eight hours with traditional sensors to as little as 15 minutes. Calibration is simple because data are stored in the sensor. The sensor is also flow independent and invulnerable to interference from acidic gases. Contact Hamilton Company www.hamiltoncompany.com
dosage formsFeatures:
online at the end of January. It was built
fully integrated services, which range from formulation development and clinical manufacturing through large-scale commercial production, packaging, quality control, and logistics. The packaging line represents a $3.5 million investment and took 14 months to complete. All testing and regulatory compliance was completed before the line’s January start-up.Contact IDT Biologika www.idt-biologika.com
CryopreservationProduct: CryoSolve single-use CGMP cell cryopreservation media Application: Cell cryopreservationFeatures: These single-use syringes with Luer-lock tips help eliminate sharps, avoid cross contamination, maintain sterility, and streamline your process. Raw materials are serum-free (USP/EP) and the medium has been shown to support an average cell viability of 97%. The products are manufactured under CGMP conditions with syringes made of USP Class VI glass, compatible with DMSO. All equipment passed compatibility studies and meets the requirements of low leachables/extractables, low toxicity, and high purity. Contact Akron Biotech www.akronbiotech.com
Virtual Disposable SystemBioselector design tool
Manifold design Purchase of bulk tubing and
fittings, assembly into disposable sets, and sterilization are costly and time consuming. The BioSelector design tool can help you generate sophisticated disposable manifolds on a desktop. The tool produces drawings of any bioprocessing system to specification and incudes authentic images of the components allowing a complex mixture of flow path sizes and devices. It can produce a virtual disposable system that resembles the manifold to be used. On completion of the design and approval by the user, the design can be emailed to any appropriate contractor for assembly.Contact BioPure Technology www.biopuretech.com
Process ObservationLiterature: Line card brochureFeatures: L.J. Star, Inc. has updated its line card of process observation equipment designed for use in sanitary applications. It includes sight glasses, sanitary fittings, visual flow indicators, light ports, vessel camera systems, and bubble traps. The line card provides a resource for finding products that address your specific processing needs including CIP and SIP applications. The new literature describes sterile visual-flow indicators, flush-mount sight windows, high-pressure in-line sight flow indicators, and MetaClamp sanitary sight glasses. Also included is a self-draining hygienic bubble trap, the first bubble trap designed specifically for pharmaceutical applications. Contact LJ Star www.ljstar.com
Contract PackagingService: Sterile packaging for liquid dosage formsFeatures: IDT Biologika’s new packaging line for sterile liquid dosage forms went online at the end of January. It was built in response to increased demand for fully integrated services, which range from formulation development and clinical manufacturing through large-
Virtual Disposable SystemProduct: Bioselector design toolApplication: Manifold designFeatures: Purchase of bulk tubing and fittings, assembly into disposable sets, and sterilization are costly and time consuming. The BioSelector design tool can help you generate sophisticated disposable manifolds on a desktop. The tool produces drawings of any
E. coli ExpressionE. coli ExpressionE. coliProduct: ScarabXpressApplication: Protein expressionFeatures: ScarabXpress is the latest strain in the multiple-deletion series of clean-genome E. coli. Based on the MDS42 strain, ScarabXpress T7laccontains a chromosomal copy of the T7 RNA polymerase gene expressed from a tightly controlled lac promoter. It is a K12 strain with a 15% genome reduction to remove nonessential genes, sequences for recombinogenic and mobile DNA, and cryptic virulence genes, while preserving robust growth and protein production. Genome reduction optimizes the clean genome E. coli as a biological factory, E. coli as a biological factory, E. coliproviding enhanced genetic stability and improved metabolic efficiency.Contact Scarab Genomics www.scarabgenomics.com
Global Marketplace
APRIL 2009 BioProcess International 57
Interferon ELISAProduct: VeriKine-HS human interferon-beta serum ELISA kitApplication: Measuring IFN-β levelsFeatures: The VeriKine-HS ELISA kit is designed to offer sensitive and reliable results measuring human interferon-beta (IFN-β) level in serum, plasma, and cell culture supernatant samples. This assay enables IFN researchers to accurately and reproducibly measure the level of IFN-β in human serum or plasma samples. It offers low serum/plasma background detection with better dose response than other ELISA kits. It can determine IFN-β levels ≥0.5 IU/mL. The kit’s excellent percent coefficient of variation (%CV), indicates data reproducibility and lot-to-lot consistency. Contact PBL InterferonSourcewww.interferonsource.com
Modular BalanceProduct: Cubis premium balanceApplication: WeighingFeatures: The Cubis premium balance features a modular design that can be custom-configured and adapted to requirements of different applications. Examples include simple weighing to managing complex sequences using the user/password management feature. It has graduated ≤12 kg weighing capacities of and 0.01 mg to 0.1 g readabilities. All balances of this series incorporate second-generation monolithic weigh cells, which make it possible to offer a space-saving, top-loading, full-resolution semimicrobalance with a readability of 0.01 mg to a capacity of 220 mg. It can be optionally equipped with a motorized draft shield.Contact Sartorius www.sartorius.com
SaniSure CLAMPSaniSure CLAMPProduct: SaniSure CLAMPApplication: Advanced sanitary non-metallic clamp used to connect two tri-clamp fittings…..whether plastic to plastic, BPE stainless to BPE stainless, or plastic to BPE stainless.Features: Features: Features: The SaniSure CLAMP is a validatable, precision-calibrated clamp giving customers a true 360 degree compression reducing gasket intrusion and misalignment. The patent pending design is optimized to improve safety, minimize wrist strain, & reduce operating costs and installation time. This innovative design has no sharp edges and is fully autoclavable and gamma sterilizable. As the industry’s attention focuses on reducing cleaning validation costs and improving tear down/installation times, this clamp answers each of these challenges, improving overall production efficiency. The SaniSure CLAMP is quick and easy to secure, light-weight, low-profile, completely tamper proof, and complies with the requirements of USP Class VI.Contact: Sanisure www.sanisure.net
UV Sensor CalibrationProduct: Calibration accessoriesApplication: UV sensor calibrationFeatures: A complete NIST-traceable calibration package is now available for inline UV sensors AF45 and AF46. These new calibration filters test photometric accuracy and linearity with absorbance ≤2.4; stray radiant energy and blocking, which is the most important test for any photometric measure; and wavelength verification and spectral stability, which ensure consistent measurement. The new design architecture eliminates measurement offsets due to interreflections. Contact Optek-Danulat, Inc. www.optek.com
Mycoplasma ControlProduct: Fluorodyne EX EDT filterApplication: Mycoplasma controlFeatures: The Fluorodyne EX EDT filter has a new hybrid sterilizing grade membrane for highest throughput and mycoplasma control. It incorporates MachV for high dirt retention, Ultipleat folds for enhanced surface area, and narrow core for increased speed. A 0.1-μm sterilizing layer rated greater than 10-log reduction of Acholeplasma laidlawii at 10Acholeplasma laidlawii at 10Acholeplasma laidlawii 7 cfu/mL. Laser barcodes simplify data capture. The filter comes in sheet, cartridge, and capsule formats, providing highest safety and economy for biomanufacturing. Contact Pall Life Sciences [email protected] or www.pall.com/biopharm.
High-Shear Fluid ProcessingProduct: M-110EH-30 ATEX microfluidizerApplications: Particle size reductionFeatures: The M-110EH-30 ATEX laboratory Microfluidizer processor is designed for continuous high shear fluid processing. It will operate at ≤30,000 psi process pressure and is recommended for particle size reduction for submicron and nano-sized particles, deagglomeration, cell disruption, immiscible liquid emulsions, solid-in-liquid suspensions, and liposomes. Using fixed geometry diamond interaction chamber technology and a ceramic plunger, the unit processes a variety of fluids, including the most difficult yeasts and plant cells.Contact Microfluidics www.microfluidicscorp.com
