Interphex Booth #1555Biopharmaceutical Grade Tubing
AdvantaFlex tubing, by AdvantaPure, is manufactured from a biopharmaceutical-grade material for the pharmaceutical, biotech, medical, and critical processing industries and is ideal for single-use applications. The tubing can be heat-sealed and welded directly to biobags and components for secure connections without the entrapment issues of fittings. AdvantaFlex is sterilizable by autoclave or gamma radiation. It offers fewer extractables than other tubing. Applications include sterile filling, vaccine production, peristaltic pump transfer systems, sampling and delivery systems, bioreactor processes, cell media and harvesting, pharmaceutical production and processing, high purity water transfer, and filtration. AdvantaPure, 888.755.4370, www.advantapure.com/advantaflex.htm.
Interphex Booth #2006Scalable Single-Use Products
Pall Life Sciences provides scalable products, which feature efficient single-use clarification systems, integrated scalable single-use processes to 1,500-L capacity, new chromatography resins, columns, and control systems. Together with new contamination control initiatives, these products can be integrated with single-use and traditional tangential flow filter systems to improve economics. Pall Life Sciences, 800.717.7255, www.pall.com.
Interphex Booth #3101Gasket for Sanitary Fittings
The Gore Sta-Pure Gasket provides dimensional stability for increased sealing reliability in critical bioprocess applications. Its construction helps achieve the low particualtion/spallation and leachable/extractable profiles that are necessary for aseptic processing. The durable construction also enables the gasket to withstand repeated clean-in-place/steam-in-place cycles. The Gore Sta-Pure Gasket was designed for the most stringent temperature and pressure requirements. Because the Gore Sta-Pure Gasket can be used universally and integrated into a variety of different systems, it can be used to standardize operations, reduce inventory, and improve purchasing efficiency. Gore PharmBIO Products, 800.294.4673, www.gore.com/pharmbio.
Interphex Booth #2411Certified Clean Low Particulate Bottles
Thermo Fisher Scientific, Inc. has introduced the Thermo Scientific Nalgene Certified Clean PETG Containers. The containers are suitable for pharmaceutical and biotechnology applications requiring the processing and storage of bulk intermediates and critical reagents such as vaccine and protein therapeutic preparations. The containers provide gas barrier properties to minimize pH shifts. The bottle and closure system is guaranteed leak-proof, making it suitable for transportation applications. The Nalgene Certified Clean PETG Containers’ packaging is designed for cleanroom applications. Bottle and closure are secured with heat-shrink bands providing a tamper-evident seal and then packaged in cleanroom-grade heat-sealed bags to assure product integrity. Thermo Fisher Scientific, Inc., 781.622.1000, www.nalgenelabware.com.
Interphex Booth #254Fermenter & Bioreactor
New Brunswick Scientific has developed a new sterilizable-in-place (SIP) fermenter and new SIP bioreactor for bench-top or mobile use, designed for convenient operation, advanced control, and the flexibility to meet changing process needs. The modular design of the BioFlo 510 fermenter and CelliGen 510 bioreactor enables you to easily add optional components at any time. Advanced controls for regulation of up to 32 loops are accessed from the large touch screen interface. Multiple analog inputs and outputs enable connection of up to 14 external sensors, analyzers, and other devices, for optimized process control. A built-in load cell measures vessel volume for precise additions and harvesting; and 24 vessel penetrations allow you to add sprayballs, sensors, and more. New Brunswick Scientific, 877.723.3317, www.nbsc.com/gen8.htm.
Interphex Booth #3319Single-Use Mixing System
The XDM Quad single-use mixing system from Xcellerex is designed for fast, convenient mixing of buffer, media, product, and other process fluids. The single-use design eliminates the hassle, cost, and delays of SIP/CIP and cleaning validation, resulting in more efficient processing and rapid batch-to-batch turnover time. Born out of Xcellerex’s experience in single-use biomanufacturing, the XDM Quad system has convenient features that simplify day-to-day process applications. Systems are scalable and are available in sizes of 100, 200, 500 and 1,000 L. Xcellerex, Inc., 866.923.5537, www.xcellerex.com/mix.
Buffers and Biochemicals
Tris Amino Tromethamine from Angus Chemical Company is used in a wide variety of pharmaceutical, ophthalmic, and other life sciences applications, where it serves as a synthesis or analytical buffer, neutralizer, solubilizer, and stabilizer. Tris Amino is a mildly alkaline chemical compound with a molecular weight of 121.14. Its chemical structure is that of a trihydric alcohol, which also possesses primary amine functionality. Tris Amino is readily water-soluble (up to 80 g/100 mL water) and possesses alcohol and glycol solubility. It is also known variously as tromethamine (USP, INCI, and CTFA), tris buffer, THAM or trometamol. Angus Buffers and Biochemicals can also provide additional resources, including special testing, custom blending, and specialized packaging and ERP connectivity. Angus Chemical Company, 800.447.4369, www.angus.com/trisamino.
Interphex Booth #2D06Ultrapure Water System
Using carbon-resin technology, the arium 611 is capable of producing 18.2 M x cm with total organic carbon (TOC) levels as low as <1 ppb at up to 2 L/min in a compact user-friendly design that has eliminated the need for a service contract. Different cartridge packs are available to meet specific feed water quality (RO, Dl, distilled water, tap water) and application requirements. Every unit of the arium 611 family includes sterile end filtration with a Sartopore capsule with a 0.2 µm PESU membrane, validated in compliance with HIMA and ASTM F-838-83 guidelines. With four different types of systems to choose from, the arium 611 is able to meet the most stringent demands for ultrapure water in the laboratory. Sartorius Stedim North America, Inc., 877.452.2345, www.sartorius-stedim.com/index.php?id=7073.
Interphex Booth #1130Contract Development Services
Cook Pharmica offers a wide array of contract development services for both mammalian and microbial systems. Our team of experienced scientists can assist you as early as cell transfection and take you through to preclinical manufacturing. Our development services include cell line and strain development, cell line adaptation, media optimization, molecular biology, scale-up and process development, purification development and analytical testing, and development of non-cGMP cell banks. We also provide small-scale GMP manufacturing up to 250-L using single-use bioreactor technology. Cook Pharmica, 877.312.2665, www.cookpharmica.com.
Interphex Booth #323Drug Development
As a CRO offering one-stop solutions, Azopharma Product Development Group provides total product development services to the pharmaceutical, biotechnology, and medical device industries. Azopharma Product Development Group’s capabilities include full IND, NCE, ANDA, and medical device development. By bundling services from key sections of the drug-development process including the preclinical, CMC, and clinical phases, Azopharma helps clients maximize their financial resources by accelerating their timelines. Azopharma Product Development Group includes Azopharma contract pharmaceutical services, AniClin preclinical services, and AnvivoClin clinical services. Azopharma Product Development, 954.433.7480, www.azopdogroup.com.
Interphex Booth #458Contract Manufacturing
Laureate Pharma is a full-service contract biomanufacturing company that accelerates new products from development through production with a focus on monoclonal antibodies and recombinant protein-based therapeutics. We provide bioprocessing services ranging from process design and development to full-scale cGMP production, purification, aseptic filling, testing, validation, analytical services, and regulatory support at our FDA registered cGMP facility located in Princeton, NJ. Laureate Pharma, 609.919.3400, www.laureatepharma.com.