Global Marketplace

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Stem Cell Harvesting



Product: CellCelector stem cell picker

Applications: Stem cell projects

Features: Through its distribution agreement with AVISO GmbH, TAP offers the CellCelector automated stem cell picker to the US, Canadian, Irish, and UK markets. The noninvasive system automates selection and harvesting of murine and human stem cells to reduce associated time and costs in research and development. Lifelike images of cells before harvest allow users to document and standardize the quality of cells chosen. The system compliments TAP’s CompacT SelecT automated cell culture system.

Contact The Automation Partnership

www.automationpartnership.com

Disposable Fluid Control



Product: Large tube clamp

Applications: Single-use fluid management

Features: Advanced Scientifics has developed a large tube clamp for controlling or stopping the flow of a fluid path through 0.75–1.75 in. outer diameter (OD) tubing (0.125-in. wall). This component includes a simple, secure locking and unlocking feature for versatility. Typical applications include biopharmaceutical manufacturing and pharmaceutical processes, disposable filtration systems, mixing containers and vessels, and assemblies and tubing sets.

Contact Advanced Scientifics Inc.

www.advancedscientifics.com

SCADA for Bioreactors



Product: BioCommand Batch Control Plus software

Applications: Bioreactor control

Features: This SCADA software package is designed for FDA-validated fermentation and cell culture processes. It incorporates advanced security features, event logs, and audit trails for 21 CFR Part 11. The OPC-compatible software enables remote monitoring and control of several fermentors/bioreactors from a single PC. Drag-and-drop icons allow users to create advanced control algorithms without programming. Other BioCommand programs provide for basic laboratory management and process optimization.

Contact New Brunswick Scientific

www.nbsc.com

Mycoplasma Filtration

Product: STyLUX SC0.1 filter

Applications: Upstream production and downstream processing

Features: This validated, sterilizing- grade, 0.1-µm rated filter provides 100% retention of mycoplasma according to a modified ASTM F838 challenge. A high-performance polyethersulfone membrane yields absolute retention of mycoplasma contaminants and bacteria at high flow rates and throughputs. The inherently hydrophilic filter also offers low extractables, low protein binding and wide chemical resistance. Filter cartridges, capsule filters, and ultrahigh- capacity UltraCap capsule filters can be used to sterilize serum, culture media, and other biological fluids.

Contact Meissner Filtration Products

www.meissner.com

Theranostics, Biomarkers

Service: Biodiagnostics development

Applications: Companion diagnostics and product testing (biomarkers)

Features: AltheaDx is a contract partner for discovery, development, and regulatory submission of new biomarkers for diagnosis and prognosis of disease. The company offers complete end-to-end biomarker discovery/development capabilities, with the ability to take a program from microarray-based expression profiling to highly sensitive measurement of biomarker gene panels with >40 genes per reaction. Using those tools, it has internally developed a number of gene expression panels and exclusive genetic tests, especially in the fields of prostate and childhood cancers, epidermal growth factor receptor (EGFR), and platinum resistance.

Contact AltheaDx, www.altheadx.com

Sterile Connections

Product: AseptiQuik connectors

Applications: Single-use fluid processing

Features: The intuitive “click, pull, twist” design of AseptiQuik connectors reduces complexity and the risk of operator error. They enable sterile media transfer even in nonsterile environments. Users can quickly connect two single-use assemblies: An audible click confirms the initial connection, pull tabs allow simultaneous membrane removal, and a twist of the integrated lock ring provides secure final assembly. The company has performed extensive validation testing (on poststerilized connectors) for functional performance, biocompatibility, and microbial ingress to confirm that external organisms are prevented from entering a flow path before, during, and after connection.

Contact Colder Products Company

www.colder.com

Label-Free Assays



Product: Octet 384 platform, Freedom EVO liquid handling workstation

Applications: Bioprocess development and drug discovery

Features: ForteBio’s Octet 384 platform (including the Octet RED384 and Octet QK384 instruments) has been integrated into Tecan’s Freedom EVO liquid handling workstation for real-time, label-free assays. The robot can use 8-, 96-, or 384-channel liquid handling arms with fixed or disposable tips for preparing assay plates. This platform enables high- throughput measurement of molecular interactions and fragment screening assays using Dip and Read biosensors.

Contact Tecan Group Ltd.

www.tecan.com

Automated Cell Culture



Product: ARS-M automated bioreactor sampling system with feedback control

Applications: Bioreactor monitoring and control in mammalian cell culture

Features: The ARS-M series of online bioreactor autosamplers can sample up to eight reactors and deliver to as many as four analytical instruments. The series is specifically designed for companies aligning themselves with the FDA’s process analytical technology (PAT) initiative. An ARS-M system can reduce product development cycles, maximize R&D and production results, and track overall product quality. Users have also significantly improved product yields as a result of efficiencies created with these systems.

Contact Groton Biosystems

www.grotonbiosystems.com

Drug Development



Service: Vetter Development Service

Applications: Biopharmaceutical product development

Features: Vetter’s facility in Chicago, IL, offers contract manufacturing from preclinical development through phase 2, with scale-up and transfer to the company’s commercial manufacturing facilities. VDS offerings include primary and secondary package development, product analysis and stability storage, and regulatory affairs, as well as process development and clinical manufacturing. Simultaneous activities coupled with expertise and foresight can reduce time to market.

Contact Vetter Pharma International

www.vetter-pharma.com

MAb Development

Literature: The Development of Therapeutic Monoclonal Antibody Products

Features: Edited by Howard Levine of BioProcess Technology Consultants and Günter Jagschies of GE Healthcare, this is a comprehensive review of chemistry, manufacturing, and control (CMC) activities and regulatory requirements in development of MAb products. The book provides in-depth analysis and recommendations for early stage product development, with detailed information on cell culture and advice on late-stage development and commercialization. The authors present strategies for accelerating development while minimizing risk and cost.

Contact GE Healthcare

www.bioprocessconsultants.com/mabreport.php

H2O2 Measurement

Product: G1114 VHP analyzer system

Applications: Cleaning validation

Features: Plastic sealed production isolators are often gently sterilized with vapor-phase hydrogen peroxide (H2O2). Picarro’s spectroscopic trace- gas analysis system is designed to provide precise, real-time measurement of trace vaporous H2O2 at ppb levels throughout its entire detection range. Concentrations above acceptable thresholds can interfere with production processes. A single pilot analyzer can screen multiple isolators without requiring dilution, concentration, or other sample preparation. It uses no consumables and can run for months without requiring recalibration. Wavelength stabilization reduces “cross-talk” from other molecules that are similar to H2O2.

Contact Picarro, Inc.

www.picarro.com

Cell Preservation

Product: CoolCell freezing container

Applications: Cell line development and cell banking, cell therapies

Features: These cell freezing containers use no alcohol to provide a −1 °C/min. cooling rate. Their solid-state core design eliminates the expense and disposal issues of isopropanol while providing cell viability equal to or better than traditional systems. When a unit is frozen, insulated construction protects users’ hands in transport; after a rapid cycle time, nearby freezer samples won’t be warmed by the thawing procedure. Each unit holds ≤12 screw-cap, 2-mL cryotubes and can be stored in a −80 °C freezer or dry ice locker.

Contact Biocision LLC

http://biocision.com

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