Products, Services, and Literature June 2008

Pilot-Scale Fermentation

Product: 19.5-L and 40-L sterilizable-in-place fermentors

Application: Bacterial, yeast, or fungal cultures

Features: BioFlo 510 is an intermediate-sized CGMP-compliant modular fermentor design for easy addition or removal of components as requirements change. The compact system offers control of =32 process loops from a touchscreen interface, with multiple analog inputs and outputs provided for connection of =14 external devices. The controller enables trend-graphing of eight process parameters simultaneously, stores multiple batch recipes, and can be used with optional SCADA software. A built-in load cell measures vessel volume; 24 vessel penetrations provide flexibility to position sensors, sprayballs and more, as convenient. Numerous options and validation packages are offered.

Contact New Brunswick Scientific www.nbsc.com/bih.htm

Technical Assistance

Services: Scale-up and technology transfer

Applications: Aseptic processing using single-use technologies

Features: Sartorius Stedim Biotech Group has opened a biotechnology technical support center in Singapore. In view of established and planned expansions of large production sites by international pharmaceutical and biotechnology groups there, the Process Application Service Singapore (PASS) will help companies transfer their processes from development centers to new production sites. Housed in the Temasek Polytechnic building, PASS offers a well-equipped pilot-plant station and specific training courses and seminars covering theoretical principles and process optimization. Available equipment includes traditional cell culture reactors, downstream technology equipment, disposable bioreactors and mixing equipment, and fluid management systems to perform ultramodern aseptic processing of biopharmaceutical media based on single-use technologies.

Contact Sartorius Stedim Biotech Group www.sartorius-stedim.com

Bioreactor Capacity

Product: GPEx^® Technology

Application: Mammalian Cell Lines

Features: Catalent Pharma Solutions will double its bioreactor capacity by 2009, adding a 1,000 liter bioreactor train in its Middleton, WI facility. Catalent has supplied two biotechnology companies with GPEx^®-produced proteins which are currently being used in U.S. FDA-approved investigational new drug (IND) clinical trials. The GPEx technology is designed to aid in the development of new biopharmaceuticals in a compliant, timely and cost-effective manner and facilitates the engineering of stable, high-yielding mammalian cell lines for protein production. To date, the GPEx technology has generated over 150 cell lines for production of recombinant proteins and antibodies. One of these cell lines is currently being used to manufacture a commercially available biosimilar product, and recombinant proteins produced from a variety of these cell lines have been used in clinical trials on three continents.

Contact Catalent Pharma Solutions www.gpextech.com

Protein Quantification

Product: Biacore T100 label-free protein interaction analysis software (Version 2)

Applications: Calibration-free protein concentration analysis (CFCA)

Features: Software enables measurement of protein concentration without a standard. It includes a single-cycle kinetics function that allows analysis of molecular interactions that were previously difficult to determine. Its data evaluation function is significantly improved so multiple samples can be analyzed together with a few simple clicks, supported by built-in quality control tools.

Contact GE Healthcare www.biacore.com

Capacity and Production

Literature: 5th Annual Biopharmaceutical Manufacturing Capacity and Production Study

Applications: Business strategy

Features: This comprehensive look at the state of worldwide biopharmaceutical manufacturing in 2007 provides quantitative information from 434 worldwide biopharmaceutical developers and contract manufacturers and more than 120 suppliers to the industry. The book includes an in-depth analysis and summary of key survey findings, trends, and implications for industry-wide biomanufacturing capacity; a comparison of production by biotherapeutics developers and contract manufacturers; trend analyses; projected capacity bottlenecks and how they might be resolved; and the joint industry expertise from many industry consultants and experts.

Contact BioPlan Associates, Inc. www.bioplanassociates.com

Clinical Services

Service: Clinical trial staffing

Applications: Phase 1–4 clinical trials

Features: ALTERNA provides customized alternative solutions to the conventional outsourcing model for Phase 1–4 clinical trials. Its integrated project management solution brings sponsor and project teams together to collaborate and agree on all aspects of a clinical study. The resulting custom-designed, time-sensitive clinical solution enables sponsors to contract for services in site management, clinical monitoring, project management, drug safety, regulatory affairs, and medical writing.

Contact Clinsys Clinical Research www.clinsysalterna.com

Isolators

Product: Labculture Reliant Class II, Type A2 Biological Safety Cabinets

Applications: Contamination control

Features: These second-generation cabinets are shorter and smaller in footprint than their predecessors. They use ULPA filters tested to a typical efficiency of >99.999% for 0.1–0.3 µm. A heavy-gauge, one-piece stainless steel liner ensures easy cleaning and durability. Cabinets feature German-made permanently lubricated centrifugal motor/blowers with external rotor designs for energy efficiency, compact design, and flat profile. Integrated assembly optimizes motor cooling, and all rotating parts are balanced for smooth, quiet, vibration-free operation. External surfaces are powder coated with Esco Isocide to eliminate 99.9% of surface bacteria within 24 hours of exposure.

Contact Esco Corporation www.escocorp.com

Detection Instruments

Product: Victor X multilabel plate reader

Applications: Drug candidate detection Features: An enhanced software package features an improved Start Wizard for easy protocol creation, with application-based example protocols for off-the-shelf use and
improved kinetics support for monitoring cellular and enzyme assays in real time. The units are designed to facilitate major accessory field upgrades, so users can add functionality as their needs evolve.

Contact PerkinElmer, Inc. www.perkinelmer.com

Microscale Culture

Product: µ-Flask (by Duetz)

Applications: Very small–scale cell culture for process development

Features: Applikon Biotechnology presents the µ-Flask, a reusable, gas-permeable closure system in standard microplate sizing. Published research shows the oxygen transfer rates to be comparable with those of baffled flasks, effectively eliminating the need for shake flasks. These microscale flasks have 100-µL to 4.0-mL working volumes and come in various configurations to match cell requirements. The plate clamps mount onto standard laboratory shakers, thereby increasing shaker and incubator capacities by several fold.

Contact Applikon Biotechnology www.applikon-bio.com

Fluid Management

Product: AdvantaFlex tubing

Applications: High-purity fluid transfer (e.g., sterile filling, bioreactor processes, filtration, and high-purity water transfer)

Features: Manufactured from a biopharmaceutical-grade thermoplastic elastomer, this tubing addresses needs for flexibility, weldability, and heat sealability. Free of animal-derived ingredients, it is formulated for low permeability and to withstand repeated compression and release. The tubing can be welded directly to biobags and other components for secure connections without fittings/clamps, and it and can be sterilized by autoclave or gamma radiation. It is heat sealable for sampling and complies with USP, ISO, EP, and FDA standards. Translucent tubing allows visual contact with the flow in sizes ranging from 1/8” through 3/4” ID. The tubing is documented lot traceable, offers documented quality control, and comes with validation and extractables test portfolios.

Contact AdvantaPure www.advantapure.com

SPR Platform Technology

Product: SPR-Navi spectroscopy system

Application: In situ determination of surface-confined molecular interactions

Features: This surface plasmon resonance (SPR) system is designed for a number of applications — from optimization of biomaterial coatings to biosensor development, lipid monolayer studies, and specific label-free biomolecular interactions. It fills the SPR gap between technically challenging but powerful ellipsometers and devices designed only to measure molecular interaction affinity. The open platform system provides flexibility and control. Simple metal-coated glass slides (optimal for custom surface modification) are easily and quickly mounted. An optical gel prevents contamination associated with the use of index-matching oils. Two separate measurement channels allow simultaneous reference or duplicate measurement. A wide angular range (40–80°) measures in both air and liquid, providing for quality checks on modified surfaces before injecting valuable liquid samples. Contact KSV Instruments Ltd. www.ksvltd.com