Biosensing

Product: SpectroSens optical microchips

Applications: Environmental monitoring and antibody detection

Features: By using light to measure change, optical biosensors from Stratophase bring precision, flexibility, and cost-effectiveness to real-time monitoring and diagnostics. The SpectroSens microchip biodetector is coated with specific antibodies that bind with high specificity and affinity to biological targets. When a given toxin, bacteria, antibody, or virus is present in a sample, it binds and triggers a positive detection. One disposable microchip can be used to test multiple samples simultaneously or several biological targets within a single sample. Online application notes describe how to use the technology for biohazard agent detection, antigens (using ovalbumin as a model), and antibodies (using IgG as a model), among other applications.

Contact Stratophase www.stratophase.com

Contract Fill and Finish

Service: Formulation and filling

Applications: Parenteral products

Features: Vetter’s first US facility offers microbiology and chemical analysis laboratories, material preparation and compounding functions, aseptic filling, and visual inspection. The first to use Bosch’s new fully automated vial filler, this Chicago facility supports preclinical through phase 2 compounds. It can vial filler, this Chicago facility supports preclinical through phase 2 compounds. It can run ≤10,000 liquid or 6,000 lyophilized vials per batch and 0.1–23.0-mL fill volumes.

A semiautomated filler works with a range of packaging materials (syringes, cartridges, and vials), ≤500 units per batch. A third cleanroom is for filling presterilized syringes.

Contact Vetter Pharma International www.vetter-pharma.com

Purity Assays

Product: QIAsymphony Certal residual DNA kit and vaccine NA kit

Applications: Confirming final biologic freedom from nucleic acid contamination

Features: These kits are designed for automated isolation of host-cell DNA and viral nucleic acids in biopharmaceuticals. Residual DNA is automatically isolated using the QIAsymphony system from purification buffers, cell culture supernatants, or vaccine preparations. The bench-top system minimizes manual hands-on time with optimized protocols to ensure consistent, reproducible results that meet regulatory requirements.

Contact QIAGEN, Inc. www.qiagen.com

GXP Testing Services

Service: Tepnel Pharma Services

Applications: Drug and biologic product testing

Features: Gen-Probe’s contract testing service laboratory in Livingston, Scotland, recently passed a GMP inspection by the US FDA, its second audit since relocating these facilities in 2008. Already, the United Kingdom’s regulatory agency has approved it for GMP, GLP, and GCP compliance. Tepnel specializes in providing pharmaceutical testing and research in batch release and stability, clinical trials support (including bioanalysis and pharmacogenomics), and immunology. Gen-Probe also offers drug development, discovery, and clinical testing services.

Contact Gen-Probe Life Sciences Ltd.www.gen-probe.com

Vaccine Adjuvant

Product: Keyhole limpet hemocyanin

Applications: Vaccines

Features: SAFC now sells CGMP-grade, high–molecular-weight keyhole limpet hemocyanin (KLH) derived through land-based aquaculture by Stellar Biotechnologies. This immunostimulatory vaccine carrier protein can facilitate transition from research to commercialization for conjugate vaccines against cancers and infectious agents. Potent but safe in humans, KLH is a critical component of certain therapeutic cancer vaccines as well as Alzheimer’s disease, rheumatoid arthritis, and lupus treatments. It also has use in immunological research for antibody generation, immune response testing, and immunotoxicology.

Contact SAFC www.safclive.com

Contact Stellar Biotechnologies www.stellarbiotechnologies.com

Protein A Chromatography

Product: AbSolute High Cap media

Applications: Antibody purification

Features: Based on modified silica, Novasep’s AbSolute High Cap protein A media were designed to capture antibodies from high-titer and large-volume feedstocks at a broad range of flow rates. These rigid and incompressible media operate at both low and high velocities (=1,000 cm/h) with long beds and smaller diameter columns. Spherical 35-m particles have a narrow size distribution, and average pore size is 100 nm ±15 nm. High productivity allows users to purify the same harvest volumes with less media, lowering the cost of expensive protein-A–based separations: an estimated US$2 million savings for a 1.5-g/L MAb titer from 20,000-L bioreactors.

Contact Groupe Novasep www.novasep.com

Binding Analysis

Product: samX acoustic biosensor

Applications: Cell–ligand binding analysis in product development and QA/QC

Features: The samX acoustic biosensor features eight analytical channels and adaptable routing for real-time analysis of molecular binding in living cells. Surface acoustic wave technology detects mass binding and protein conformation changes in whole cells without labeling. Channels can be used alone or in combination to optimize workflows. Different ligands can be immobilized at each chip position automatically without off-line protein loading — e.g., to directly quantify the amount of protein bound to each sensor chip for accuracy and reliability of results.

Contact SAW Instruments GmbH www.saw-instruments.de

Contamination Monitoring

Product: aCOLade colony counter

Applications: Contamination analysis and QA/QC microbiology

Features: The aCOLade manual colony counter from Synbiosis provides automatic result recording of microbial contamination analyses. A compact white light box with a magnifying lens, a pen, and a gridded, pressure-controlled back plate are integrated with a digital counter. Users touch a Petri dish lid with the pen to count a colony, and a beep and display confirms the automatic addition. The unit comes with software to automatically transfer counts to a spreadsheet and holds 50-mm, 90-mm, and 120-mm diameter plates for a range of applications.

Contact Synbiosis www.synbiosis.com

High-Salt Separations

Product: Sartobind Pico with Sartobind STIC PA membrane

Applications: Downstream process development and viral safety

Features: The Sartobind Pico 0.08-mL capsule size completes Sartorius Stedim’s portfolio of salt-tolerant membrane adsorbers using the Sartobind STIC primary amine (PA) anion-exchange membrane. It binds contaminants at high conductivities under high-salt conditions at ≤20 mS/cm to directly process cation-exchange pools without dilution. That reduces buffer consumption and buffer tank investment. The plug-and-play Sartobind STIC capsule family includes pico-, nano-, 5-in., 10-in., 30-in., and mega-capsules for flow-through polishing. A 4-mm bed height is kept constant for scaling up to 1.6 L. The Pico membrane volume reduces material consumption during testing and virus spiking studies to reduce costs during the initial development phases.

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

Enhancing LC/MS

Product: Acrodisc MS syringe filters

Applications: Lowering extractables in high-performance liquid chromatography (HPLC)–mass spectrometry (LC/MS) analysis

Features: Acrodisc MS syringe filters improve LC/MS accuracy and assay performance and extend the longevity of testing instrumentation. They minimize interference to lower costs and minimize contamination-related downtime and retesting. Made with Pall’s WWPTFE membrane in a high-density polyethylene housing, the filters are individually packaged for protection against contamination. They can be used with organic and aqueous solvents, are chemically resistant, and provide good particulate retention with minimal protein adsorption.

Contact Pall Life Sciences www.pall.com/lab

Light-Scattering Analysis

Product: Calypso composition-gradient multiangle light-scattering (CG-MALS) instrument

Applications: Macromolecular characterization and QA/QC

Features: The Calypso system determines affinity and binding stoichiometry for unfractionated macromolecules in solution without tagging. This alternative to size-exclusion chromatography and field-flow fractionation keeps antibodies and antigens in close proximity to probe their interactions: e.g., reversible protein self- and heteroassociation, reaction rates and affinities of irreversible aggregation, and virial coefficients. Automation capability improves repeatability and realiability while minimizing analysis time and operator effort.

Contact Wyatt Technology www.wyatt.com

Blood Factor Processing

Product: VIISelect resin

Applications: Purifying recombinant blood-factor proteins

Features: GE Healthcare Life Sciences added a new affinity chromatography resin from BAC BV to its bioprocessing product line. In a custom project, the companies worked with a mutual client to jointly develop VIISelect resins for CGMP purification of Factor VII and Factor VIIa blood cagulants from recombinant feedstocks. This highly selective resin provides high Factor VII/VIIa purity in a single unit operation at laboratory and production scales. BAC technology uses small (14-kD), Camelid-derived single-domain antibody fragments as affinity ligands.

Contact GE Healthcare Life Sciences www.gelifesciences.com

Contact BAC BV www.bacbv.com