GLOBAL MARKETPLACE November 2011

Aseptic Material Transfer

Product: FlexFill single-use biocontainer transfer assembly

Applications: Aseptic transfer of bottled media, sera, reagents, supplements, buffers, and microcarriers to bioreactors

Features: Meissner’s FlexFill assembly is designed for applications requiring fast and dependable aseptic transfer of small liquid process volumes. Its large screw-cap port allows for rapid and convenient filling of disposable biocontainers in laminar flow hoods using a portable stainless steel FlexCessory stand. The assemblies can be customized to support a range of fitting and tubing options. Made of pharmaceutical-grade TepoFlex film, they are available in 500-mL to 6-L volumes.

Contact Meissner Filtration Products, Inc. www.meissner.com

Disconnecting Disposables

Product: Clipster aseptic disconnector

Applications: Aseptic disconnection of single-use assemblies

Features: The Clipster aseptic disconnector from Sartorius Stedim Biotech is a disposable device for disconnecting single-use transfer lines and bag assemblies in biopharmaceutical applications. Validation has been carried out with stringent test regimes: Biological and physical tests were combined to provide data representing a range of process conditions. It is designed for disconnecting silicone tubings and comes as a stand-alone product or preassembled with single-use transfer lines and bag assemblies. The devices come in 0.375-in. × 0.625-in. and 0.5-in × 0.75-in. sizes.

Contact Sartorius Stedim Biotech www.sartorius-stedim.com

Adapt to Single Use

Products: AdaptOr kits

Applications: Adapting autoclavable bioreactor systems to single use

Features: New Brunswick Scientific’s adapter kits allow you to use 5-L and 14-L CelliGen BLU single-use vessels with a range of existing bioreactor systems using Applikon BioBundle controllers. Additional kits are in development. All vessel components in product contact are made of USP Class VI materials and have been tested for leachables and extractables so they can be used in GMP environments.

Contact New Brunswick Scientific, Inc. www.nbsc.com

Single-Use Mixing

Product: SaniSure gamma-stable stir bar

Applications: For containers in which product needs to be agitated and remain in suspension (if and when traditional mixers may inhibit cell growth)

Features: SaniSure gamma-stable stir bars are made with industry-accepted PVDF contact material to minimize particulate shedding. (Standard PTFE stir bars are not recommended for gamma irradiation, limiting their use in biopharmaceutical single-use assemblies.) These lightweight stir bars are ADC-free and meet USP class VI requirements. They come in eight standard sizes and can be customized with different diameters, lengths, configurations, and materials to suit specific applications.

Contact SaniSure, Inc.www.sanisure.com

Single-Use Bioreactor

Product: CELL-tainer bioreactor

Applications: High-density cell cultures

Features: CELLution Biotech’s CELL-tainer single-use bioreactor provides two-dimensional motion for oxygen uptake and CO₂ removal. Cells grow at high densities, enabling greater production in the same volume of culture. A single bioreactor bag allows for 150-mL to 15-L working volumes. Patented technology offers short mixing times, high mass-transfer rates, and reliable measurement and control of temperature, pH, dissolved oxygen, and rpm speed. Bacteria and yeast cultures (as well as mammalian and insect cells) can be grown at high density. Traditional pH and DO probes are integrated into the bags, with measurements monitored through dialysis membranes.

Contact ATR Biotech www.atrbiotech.com/celltainer.htm

Universal LC Analysis

Product: Intelligent System Emulation Technology (ISET) for the 1290 Infinity LC system

Applications: High-performance and ultrahigh-pressure liquid chromatographic (HPLC/UHPLC) analysis

Features: Agilent Technologies added ISET to allow its 1290 Infinity LC system to emulate other chromatography systems (regardless of brand) for seamless method transfer. This allows the system to emulate other instruments with a simple mouse click and run existing methods without modifications, while delivering the same retention times and peak resolution. QA/QC laboratories can run legacy methods unchanged even as they take advantage of the speed, resolution, and sensitivity of newer methods.

Contact Agilent Technologies www.agilent.com/chem/1200

Hose Identification

Products: b> AdvantaLabel, DocuLink, HoseTrack, GammaTag, and others

Applications: Rapid, accurate identification of bioprocess hoses and manifolds for safety, traceability, and regulatory compliance

Features: AdvantaPure’s options for hose identification include color tracing, laylines, and laser-etched hose collars and tags. Trademarked methods include AdvantaLabel color stripes and labels, DocuLink software, and Hose Track and GammaTag radio-frequency ID tags (the latter capable of withstanding gamma irradiation). These can be used separately or in combination for multiple-tier identification.

Contact AdvantaPure www.advantapure.com

Disposable Filling

Product: PreVAS system

Applications: Liquid product filling

Features: Bosch Packaging Technology’s PreVAS disposable filling system concept was developed in cooperation with a strategic partner for disposable materials. Flow behavior, interfaces, tubing layout, distribution, and connection-point aspects are pursued holistically. Mock-ups of the customizable systems are useful in creating operator-friendly layouts of transfer and glove ports. A Bosch peristaltic pump permits toolless and single-handed tubing change that is well suited for isolators. The pump handles volumes ≤500 mL, and an autoclavable version comes with a removable pump head and connections made from PEAK plastics.

Contact Bosch Packaging Technology www.boschpackaging.com

Automating Osmometry

Product: Advanced 2020-BIO automated osmometer

Applications: Osmolality testing

Features: The 2020-BIO features remote system control, open connectivity, and bidirectional data transfer for laboratory automation platforms. It uses the industry’s preferred freezing-point method for highly accurate osmolality determinations and streamlines workflow and data integration.

Contact Advanced Instruments Inc.www.aicompanies.com

Contract Testing

Service: Compendial raw materials testing

Applications: Protein research and product development

Features: At an expanded and relocated facility in Wilmington, NC, AAIPharma Services combines its compendial raw-material testing laboratory and supporting business under one roof to offer a standard 10-day turnaround time for most tests. The new GMP lab features state-of-the-art engineering controls, updated IT infrastructure and gas generation systems, HPLC systems for increased throughput, and updated support systems, including a Lancer glassware washer and MilliQ water systems. The move improves laboratory integration with other services, and it does not constitute a site change.

Contact AAIPharma Services Corp.www.aaipharma.com

HPLC Columns and Media

Products: Hypersil GOLD C4, Amino, AX, SAX, and Silica columns

Applications: Research and analysis of proteins, peptides, sugars, carbohydrates, nucleotides, organic acids, and other anionic, polar, and organic molecules

Features: Thermo Fisher Scientific has added five new phases to its Hypersil GOLD family of high-performance liquid chromatography columns. A C4 phase broadens the scope of reverse-phase selectivities, and other options provide for analysis by ion-exchange, HILIC, and normal-phase chromatography. All use the same pure-silica background for symmetrical peaks, come with 1.9-µm particles, and work with both HPLC and ultra-HPLC systems.

Contact Thermo Fisher Scientific www.thermoscientific.com/columns

Outsourcing

Service: Contract formulation design, manufacturing, analytical and stability testing, and process development

Applications: Early stage biotechnology and pharmaceutical products

Features: QuaDPharma is a CGMP-compliant contract provider of early stage services to the pharmaceutical and biotechnology industries. The management team has years of industry experience guiding the design, development, production, and validation of new drug products as they progress through clinical trials. The company also supports its clients with technical writing services and consulting in formulation chemistry, GMP quality systems design, and regulatory audits and investigations.

Contact QuaDPharma, Inc. www.quadpharmainc.com