GEA presented its new kytero Single-Use Pharma Separator at the Single-Use Conference in Leiden, the Netherlands, last month.
The equipment, designed for obtaining fermentation solutions and cell cultures, comprises GEA Westfalia Separator disk stack technology for maximum yield, high separation efficiency and gentle product handling, said the company.
A 500-liter batch of animal cells is processed in about four hours.
“The GEA kytero combines the high performance of larger GEA stainless steel pharmaceutical centrifuges with the features and benefits offered by disposable separation. This type of equipment is in high demand for animal cell and gene therapy processes, as well as for pilot plants, university laboratories, in R&D environments and small-scale production, and by biopharmaceutical manufacturers worldwide, as it relies on centrifugation to significantly reduce filtration dependency.”
All elements in contact with the product, such as hoses and containers, are made of recyclable material and are replaced after use to ensure no cross-contamination and hygienic harvesting of the cells, said the manufacturer.
The design of the aseptic connector system makes the exchange of single-use components fast and very easy, it continued.
“The small footprint of the GEA kytero for single-use processing makes it highly mobile and minimizes the need for expensive storage or production space. Buffer tanks are not required. The elimination of clean-in-place (CIP) and sterilize-in-place (SIP) also eliminates the cost of chemicals and water, especially water-for-injection (WFI). In addition, the energy and labor required for cleaning and sterilization are eliminated.”
Set-up and changeover time is minimal. No auxiliary equipment such as water, buffers or tanks are required, while the noise level is very low, said GEA.
The unavoidable temperature increase of the product during centrifugation is minimal at less than two degrees, it added.
Thermo Fisher Scientific has introduced the Thermo Scientific HyPeak Chromatography System, which is the first single-use chromatography system for bioprocessing offered by the company.
The equipment is applicable for use in therapeutic and vaccine development.
Other commercially available single-use chromatography system options are limited in their scalability, said the developer, but the HyPeak Chromatography Systems offers a wide operational flow range through a combination of pumps and fluid transfer assemblies that enable scalability from process development to cGMP manufacturing.
The company highlighted the equipment's key benefits:
- Increased scalability: "Available as a single system for process development and production scale for reduced capital expenses and a more efficient facility footprint."
- Higher product yield: "Addresses traditional chromatography challenges, where valve and FTA designs may result in buffer holdover, resulting in lower yields."
- Simplified tech transfer: "Built on the widely used Emerson DeltaV automation platform to enable upstream and downstream data integration and the TruChrom application provides a versatile user interface."
Photo Credit: Chris Conroy Photography
TurboFil will showcase a module for automated, simplified production of a wide range of syringe formats at the INTERPHEX trade show this month.
“Employing a versatile yet precise setup that accurately fills syringes via ceramic piston, peristaltic pump or direct draw from a reservoir bag, the company said its SimpliFil Syringe Filling & Assembly System is suitable for small to medium batches.”
The technology comprises a walking beam indexing configuration, which the equipment specialist said provides intuitive operation and simplified, recipe-based changeover.
For heightened precision, TipFil technology is said to allow syringes to be filled through the tip, a step-saving innovation eliminating the need to insert plungers post-filling.
Filling up to 36 syringes per minute, the SimpliFil system handles syringes with tips outfitted for press-on caps and luer caps, as well as various safety caps recently incorporated for oral syringes, added the New York based company.
For post-capping marking applications, TurboFil said there is also an optional labeler that can wrap syringes with pre-printed labels or, for medications requiring variable marking, print individual labels per uploaded input. An automatic syringe loading system also is available, as is a volume and vision system for fill and label matching verification.
New tech is aimed at providing the biopharma industry with a single instrument to meet compliance standards and verify data with images.
Yokogawa Fluid Imaging Technologies is introducing FlowCam LO to the market; it calls it the first and only light obscuration (LO) instrument with imaging capabilities.
“This easy-to-use instrument combines Flow Imaging Microscopy (FIM) with LO to deliver a powerful, all-in-one solution that meets compliance standards while allowing verification with high-resolution images.
“Regulatory agencies have long made clear that orthogonal particle characterization methods are necessary, especially for protein-based biologics since size and counts from LO alone are not adequate to ensure product quality and stability. The FlowCam LO fulfills this need, while providing a single USP-compliant software package for acquisition and analysis of multiple data sets and reporting via VisualSpreadsheet Software.”
The FlowCam LO, it continued, bridges the gap between product formulation and QA/QC requirements.
“Customers are looking for ways to speed drug development while also adhering to increased regulatory requirements. The FlowCam LO brings together two critical particle characterization techniques in a single platform to meet this demand,” said Ross Bryant, CEO, Yokogawa.
Biotium, a supplier and inventor of fluorescent cellular probes for life science research, has announced the release of infrared CF850 and CF870 dyes.
The company said the long wavelength dyes are the first commercially available fluorescent dyes with emission maxima greater than 850 nm, allowing researchers to further investigate the 'final frontier' of infrared wavelengths for life science research applications, said the firm.
"Due to their excellent brightness, aqueous solubility, and exceptional infrared properties, CF850 and CF870 represent a true breakthrough in synthetic fluorescent probes."
Their sensitivity, linearity, tissue penetration, and minimal autofluorescence background are beneficial for in vivo imaging, western blotting, and microscopy, according to Biotium.
“Recently, the benefits of long wavelength fluorescence have spurred the development of flow cytometers and imaging instrumentation equipped with near-IR laser diodes and detection systems. Biotium’s CF850 and CF870 dyes aim to accommodate research that takes advantage of these hardware advancements by offering long wavelength emission beyond any commercially available IR probe.”
High Purity New England (HPNE) has launched the new FlowMaxx Pro, which it says is a completely redesigned version of its Quaternary Diaphragm Smart Pump.
The revamped tool includes a larger touchscreen, multiple modes of functionality, integrated sensor selection, and extended flow rate ranges, said the provider.
Users can access the device without logging in, while new modes including continuous mode, time dispense, volume dispense, and PID control, a built-in diaphragm failure notification, and an improved fan to limit heat generation, reported HPNE.
The company also flagged that the pump line allows for calibration of sensors to measure flow and pressure and an alarm to prevent the pump from running without being connected to the sensor. “Furthermore, through the new ethernet connection, the team at HPNE can troubleshoot most issues remotely, allowing the product to be fixed on-site, saving the end-user both time and costs.”
CrestOptics, a manufacturer of high-end microscopy solutions and advanced systems for fluorescence microscopy and diagnostic applications, has just released DeepSIM, a super resolution module designed to enhance the imaging capabilities of confocal microscope systems.
It says the DeepSIM module can be used with Crest’s X-light V3 spinning disk, or alternative confocal systems, to offer high-resolution images for life science researchers.
As well as being launched virtually in Europe at the EMBO and EMBL Imaging Symposium today [October 4, 2021), the technology will be released to the US market at Neuroscience 2021 next month.
