Syringe Technology

Product: Dual-chamber Lyo-Ject syringe and V-LK cartridge

Applications: Delivery of lyophilized, liquid-powder, and liquid-liquid mixtures

Features: Vetter offers two efficient and user-friendly systems for freeze-dried parenteral drugs: the dual-chamber Vetter Lyo-Ject syringe and dual-chamber V-LK cartridge. Lyophilized drug is contained in one chamber; diluent in the other. Reconstitution occurs immediately before administration in a few simple steps. This technology simplifies administration, increases API yields (by reducing overfill), and improves dosing precision. Syringes come in 1-mL, 2.5-mL, and 5-mL sizes; cartridges cover fill volumes of 0.1–1.4 mL in their first chamber and 0.1–1.3 mL in their second.

Contact Vetter Pharma International www.vetter-pharma.comSterile Connections

Product: Opta SFT sterile fluid transfer connectors

Applications: Fluid-management systems including filters, tubing, and disposable storage containments; bulk material management and transfer in noncontrolled environments; sampling from single-use bioreactors; and recirculation loops in ultrafiltration/diafiltration processes.

Features: Opta SFT connectors from Sartorius Stedim allow sterile connection between two separate, presterilized components in biopharmaceutical manufacturing processes. These single-use connectors come with 0.25-in., 0.375-in., and 0.5-in. hose barbs for small-body connectors and now a 0.75-in. hose barb for large-body connectors. These connectors will be integrated into fluid management assemblies and be available separately for end-user assembly with silicone or TPE tubing and autoclave sterilization.

Contact Sartorius Stedim Biotech SA www.sartorius-stedim.comVenting Filters

Product: Steridyne and Ultradyne filters

Applications: Sterile venting of carboys, filling vessels, bioreactors, and tanks; small-volume filtration

Features: Meissner’s Steridyne 50 (PVDF) and Ultradyne 50 (PTFE) 50-mm filters can be used for small-volume venting as well as gas and solvent filtration. They come with stepped barb inlet–outlet connections. Designed and supported for bidirectional flow, these 0.2-µm rated filters can serve as hydrophobic vents or to filter up to a liter of aggressive solvents and aqueous solutions (when prewet with a low–surface-tension fluid such as alcohol). They can be gamma irradiated or autoclaved up to 30 times.

Contact Meissner Filtration Products www.meissner.comSingle-Use Disconnections

Product: Kleenpack sterile disconnectors

Applications: Sterile separation of flexible tubing assemblies

Features: Single-use Pall Kleenpak sterile disconnectors facilitate secure fluid transfer, preserve product integrity, improve operator safety, and reduce product waste in biomanufacturing. A patented locking mechanism eliminates risks associated with clamping and cutting and requires no tools, calibration, or maintenance. Disconnection takes <30 seconds, and flow paths cannot be reopened or reconnected afterward, thus further securing product integrity. These devices can withstand autoclaving ≤130 °C or gamma irradiation ≤50 kGy.

Contact Pall Corporation www.pall.comProduct Characterization

Product: Biopharmaceutical System Solution UPLC/MS analysis system

Applications: Proteins and peptides

Features: Waters’ solution for biopharmaceutical analysis incorporates an ACQUITY UPLC H-Class Bio system (with a bioinert flow path and quaternary solvent management with Auto•Blend Plus technology for bioseparation flexibility); peptide and protein separation columns (engineered to leverage the characteristics of biomolecules and QC-tested to ensure consistent results); and a Xevo G2 ToF mass spectrometer. UNIFI scientific information software controls the instruments and provides for data processing, mining, and reporting, with GxP laboratory compatibility.

Contact Waters Corporation www.waters.comAssay Development

Product: SoPRano assay kit

Applications: Diagnostics and label-free screening

Features: Users of the SoPRano kit from PharmaDiagnostics can couple their own proteins to SoPRano gold nanoparticles to build and run their own custom assays. It requires no specialized equipment, offering the first high-throughput, label-free screening for standard plate readers. Previously available only as a service, the technology is a variant of surface plasmon resonance measurement. Kits are available for a range of applications, including fragment screening, antibody discovery, and measuring ADME and physicochemical properties such as plasma protein binding, pK_a, and redox potential.

Contact PharmaDiagnostics NV www.pharmadiagnostics.com