Single-Use Technology

Product: inSITE inflation and integrity testing system

Applications: Media/buffer preparation, filtration, separations, seed/culture harvest, ultrafiltration, final filling

Features: ASI’s inSITE system applies a final integrity test at the point of use to eliminate concerns for gross and fine leaks that can come from handling and loading procedures. The unit will inflate to a specified pressure to limit errors from pinching and creasing. It can be used with any container ≤3,000 L and is completely mobile with cleanroom-grade wheels and a light-weight design. An on-board printer documents test results, and a scanner provides access to product details.

Contact ASI Life Sciences www.asius.com

Electroporation

Product: AgilePulse In Vivo electroporation system

Applications: Vaccines and gene therapies

Features: The AgilePulse In Vivo electroporation system uses variable pulse-amplitude technology with patented waveforms consisting of multiple, varying low- to high-pulses. This promotes cell membrane poration for maximum transfection efficiency, with minimal damage to cells or tissues. Resistance measurement ensures proper needle placement and reproducibility, and specially designed needle arrays allow for intramuscular or intradermal applications.

Contact BTX (Harvard Apparatus) www.btxonline.com

Freeze-Drying Control

Product: ControlLyo technology

Applications: Lyophilization

Features: GEA Lyophil (part of GEA Pharma Systems) has licensed Praxair’s ControLyo nucleation on-demand technology. It optimizes the freezing step of lyophilization by controlling nucleation temperature to within 1 °C of its freezing point. This improves product uniformity, quality, and yield, and it reduces cycle times by ≤40%. Praxair’s technology requires no changes to existing drug formulations and can be retrofitted to most freeze dryers with minimal effect on established lyophilization protocols.

Contact GEA Lyophil GmbH www.geapharmasystems.com

Contact Praxair Inc. www.praxair.com

Custom Tubing

Service: Compass technology

Applications: Fluid management

Features: Combining expertise in custom material compounding with high-precision silicone extrusion and fluid modeling, Saint-Gobain Performance Plastics can design application-specific formulations and products for optimized performance. Tolerances in material properties and product dimensions reduce overall system variability. With Compass technology, a closed-loop system automatically adjusts the extrusion process to reduce variation among production runs and monitors in-process manufacturing data. Those are captured and made available in a detailed package to expedite medical device product validation.

Contact Saint Gobain Performance Plastics www.medical.saint-gobain.com

Contract Development

Service: Development and analytical solutions

Applications: Biopharmaceutical development

Features: From a new laboratory suite at the Swindon, UK, facility, Catalent offers analytical testing, development support, and regulatory services. These include European import testing; qualified person (QP) and other consulting services; analytical method development; and microbial, sterility, and stability testing for a range of advanced dose forms such as inhaled and orally administered substances. The suite incorporates expanded facilities for storage and testing of controlled and cytotoxic substances. Along with the company’s international network, this extends the range and scale of services for both large and small molecules.

Contact Catalent Pharma Solutions www.catalent.com

Environmental Monitoring

Product: Vegetable Contact Agar + LTHTh – ICRplus

Applications: Viable-particle monitoring of isolators and cleanrooms

Features: Millipore’s ready-to-use Vegetable Contact Agar + LTHTh – ICRplus plate helps analysts determine microbial counts on surfaces. Because this peptone agar is of nonanimal origin, the device also minimizes the risk of transmissible spongiform encephalopathy (TSE) transmission. The surface count of bacteria, yeast, and/or mold can be determined under both aerobic and anaerobic incubation conditions. A series of neutralizers will counteract disinfectants, allowing microorganisms to grow even if the surface contains residual disinfectant. The device has a long shelf life at room temperature.

Contact EMD Millipore www.millipore.com

Disposables Containment

Product: QuaDrum containers

Applications: Single-use technology

Features: QuaDrum rigid outer containers offer a square alternative to industry-standard cylindrical drums. The unique footprint maximizes floor space use with improved stability. It also facilitates the easy, accurate, and repeatable use of compatible 3D TepoFlex single-use biocontainer assemblies. An optional stainless steel dolly provides intra-facility mobility.

Contact Meissner Filtration Products www.meissner.com

Liquid Handling

Literature: MVS (Multichannel Verification System) application notes

Applications: Microplate analysis

Features: Artel introduces two new applications of its MVS Multichannel Verification System instrument to verify key assay work-flow steps for gaining reliable results. One note applies the MVS system to ensuring complete mixing of solutions in microplates, which is critical for assay effectiveness and repeatability, especially for assays requiring dilution of mixed samples. The other note provides a method to measure plate-washing effectiveness. Failure to remove residual liquids from microplates can lead to incorrect measurements, which can lead to faulty and misinterpreted results.

Contact Artel www.artel-usa.com/application_notes.aspx

Product Development

Service: Contract development and manufacturing

Applications: Clinical- and commercial-scale complex biologics

Features: Therapure Biopharma specializes in biologics development, scale-up, and manufacturing. At its 130,000-ft² CGMP facility in Toronto, Ontario, Canada, the company offers cell-line, process, and analytical development; product manufacturing and testing; and aseptic fill–finish and lyophilization. It has >20 years of experience working with mammalian and primary cell cultures, whole blood, and plasma sources.

Contact Therapure Biopharma www.therapurebio.com