Service: Flexible options in final assembly and secondary packaging
Applications: Drugs and biologics
Features: An international specialist in aseptic fill–finish, Vetter offers a range of options for final assembly and packaging of pharmaceutical and biotech products. The company provides semi- and fully automated secondary packaging; labeling, blistering, cartoning with package inserts, and case packing; assembly of pens, autoinjectors, and other safety devices; and high standards of cosmetic integrity.
Contact Vetter Pharma International
Microbioreactors
Product: ambr workstation
Applications: Drugs and biologics
Features: TAP’s new, larger “ambr” microbioreactor system automates operation of 48 disposable microbioreactors and closely replicates characteristics of benchtop bioreactors at microscale (10–15 mL working volume). Those 48 are arranged in four sets of 12, each with a miniature internal impeller and individual closed-loop control of dissolved O2, pH, and gas supply. Each culture station has independent stirring speed and temperature control for testing up to four sets of conditions simultaneously. Users can set up and leave experiments for automatic aseptic processing and monitoring overnight or on weekends.
Contact The Automation Partnership
IgG Detection
Product: Dip and Read protein G biosensor for Octet system
Applications: Antibody analysis
Features: This protein G biosensor enables fast, easy, and cost-efficient measurement for rapid detection and quantification of mammalian immunoglobulin (IgG) in solution. Recombinant protein G is preimmobilized on the sensor surface, so it’s ready for an Octet instrument(based on proprietary label-free BioLayer Interferometry technology, which optically measures multiple interactions in parallel).
Contact ForteBio, Inc.
Fluid ManagementProduct: FitQuik fittings
Applications: Single-use fluid paths
Features: The latest additions to the FitQuik product line include hose-barb- to-hose-barb tees, straights, elbows, and Ys, along with Luer locks — all made from medical-grade polycarbonate. The new fittings provide biocompatibility, robustness, and heat resistance. FitQuik connectors feature precise hose barbs and thread forms to ensure a secure, reliable fit. Available in nylon, polypropylene, and now polycarbonate, the fittings are designed for 1/16”–3/8” tubing sizes.
Contact Colder Products Company
Protein AnalysisProduct: ViBE bioanalyzer and workstation
Applications: Tissue, tumor, whole blood, plasma, serum, urine, stool, and bioreactor samples
Features: Nonoptical detection, assay flexibility, and enhanced sensitivity enable the BioScale platform to detect and quantify many types of analytes from a range of complex matrices. Analytes of interest are separated and concentrated directly from samples, then analyzed in real-time without interference from the surrounding matrix. The entire process takes place in a disposable cartridge designed to be used with complex samples and to prevent clogging. It works at concentration ranges from pg/mL to mg/mL, depending on the application.
Contact BioScale, Inc.
Media SupplementsProduct: Regocel chemically defined supplements
Applications: Cell culture
Features: Through a sales and marketing alliance with Girus Life Sciences, Sheffield Bio-Science is exclusively offering Regocel supplements. These chemically defined supplements are small-molecule yield enhancers designed to improve cell culture performance. They were developed to enhance protein production while maintaining cell viability, thus increasing overall biomanufacturing efficiencies. Supplements are commercially available for use with Chinese hamster ovary (CHO), hybridoma, NS0 myeloma, and stem cells.
Contact Sheffield Bio-Science (part of the Kerry Group)
Fluid Transfer
Product: APST tubing
Applications: Upstream and downstream processing, process development and manufacturing
Features: AdvantaPure’s platinum-cured silicone tubing now comes in nearly 50 sizes, with 0.030-in. to 1.000-in interior diameters. Manufactured from low-volatiles–grade silicone, this flexible tubing offers a hardness value of 50 Shore A
and contains no animal-derived ingredients. Meeting US and European pharmacopeial, ISO, and CFR standards, the tubing comes in temperature grades from –100 °F (–73.3 °C) to 400 °F (204.4 °C). It can be sterilized by autoclave or gamma radiation.
Contact New Age Industries
Process Control
Product: eControl 8611 controller
Applications: Biologic production
Features: Bürkert offers a universal controller for flow rate, pressure, temperature, pH value, conductivity, and fluid/gas-flow ratio. The eControl8611’s preconfigured control systems and background components prevent coordination problems among individual components and facilitate commissioning. Five versions have different mounting systems for wall, hat rail, switch-cabinet, and direct mounting. The controller works with a range of valves and sensors for different types of bioreactors, fermentors, and related equipment.
Contact Bürkert Werke GmbH
Perfusion Cell Culture
Product: Hydrocyclone perfusion system
Applications: Biomanufacturing and process development
Features: Hydrocyclone perfusion technology works with small- to large- scale multiuse or single-use bioreactors. As the only disposable cell retention device for perfusion-mode cultures,it requires no cleaning or cleaning validation. Its compact design handles perfusion rates from 10 L/day to720 L/day. At laboratory to production scales it has shown >95% separation performance (with hybridoma cells) and high viable cell concentrations.
Contact Sartorius Stedim Biotech
Fill–Finish ServicesService: High-speed syringe filling
Applications: Prefilled syringe products
Features: Althea has completed installation of an INOVA H3-5 high-speed syringe filling line at its large-scale and commercial manufacturing facility in San Diego, CA. This expanded capacity allows the company to provide clients with prefilled syringe services from early development through commercial supply scale. A restricted-access barrier system supports filling under vacuum for facilitated handling of highly viscous products that require minimal head space. Available for production of GMP batches in the first quarter of 2011, the new line accommodates nested syringes from a range of suppliers in >100,000- unit batch sizes.
Contact Althea Technologies, Inc.
Contract ManufacturingService: XSpedite microbial services
Applications: Biologics made using microbial fermentation
Features: Lonza’s XSpedite service offers fixed-price manufacturing of microbially derived biopharmaceuticals, up to1,000 mg. The company guarantees a minimum quantity rapidly delivered after initial laboratory evaluation. This offering integrates existing and innovative platform technologies and systems to provide non-GMP proteins and plasmid DNA for critical preclinical and proof-of- concept testing in 10–15 weeks (strain to purified product). By facilitating efficient development of expression and purification processes, the service package enables customers to accelerate early stage programs without investing in full GMP process development.
Contact Lonza Group Ltd.
Protein ReagentsProduct: Reagentproteins.com
Applications: Biologics discovery, development, and commercialization
Features: The Reagent Proteins business unit of Pfenex Inc. offers a product list of ~2,300 proteins including stem cell growth factors, cytokines, chemokines, and enzymes. Preclinical- and CGMP-grade vaccine carriers, adjuvants, and antigens will be available in liquid formulations and lyophilized forms. The company accepts requests for new product offerings through its website. Through an August 2010 agreement, Cedarlane Laboratories Ltd. (www.cedarlanelabs.com) will also market and distribute high-value reagent proteins produced by Pfenex to researchers in Canada and the United States.
Contact Reagent Proteins