Global Marketplace April 2009

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

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

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

Contract Packaging

Service: Sterile packaging for liquid dosage forms

Features: 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-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

Virtual Disposable System

Product: Bioselector design tool

Application: Manifold design

Features: 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 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.1jstar.com

Modular Balance

Product: Cubis premium balance

Application: Weighing

Features: 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 CLAMP

Product: SaniSure CLAMP

Application: 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: 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

Mycoplasma Control

Product: Fluorodyne EX EDT filter

Application: Mycoplasma control

Features: 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-m sterilizing layer rated greater than 10-log reduction of Acholeplasma laidlawii at 10⁷ 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]”>www.pall.com/biopharm.

www.optek.com

Interferon ELISA

Product: VeriKine-HS human interferon-beta serum ELISA kit

Application: Measuring IFN- levels

Features: The VeriKine-HS ELISA kit is designed to offer sensitive and reliable results measuring human interferon-beta (IFN-) level in serum, plasma, and cell culture supernatant samples. This assay enables IFN researchers to accurately and reproducibly measure the level of IFN- 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- levels =0.5 IU/mL. The kit’s excellent percent coefficient of variation (%CV), indicates data reproducibility and lot-to-lot consistency.

Contact PBL InterferonSource www.interferonsource.com

High-Shear Fluid Processing

Product: M-110EH-30 ATEX microfluidizer

Applications: Particle size reduction

Features: 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