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
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.
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
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
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.comSterile 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
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.
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
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
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
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.
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