Sepha says it has achieved micro leak detection down to one-micron (1µm) with the development of a new high-performance leak tester for Container Closure Integrity Testing (CCIT) applications.
Utilizing the vacuum decay test method, the new Multi-Q HD unit is designed to enable ultra-sensitive, non-destructive detection of defects in pharmaceutical containers, said the Belfast, Northern Ireland headquartered developer.
This enhanced testing functionality responds to demand from parenteral formats, which are experiencing unprecedented growth on the back of international Covid-19 vaccination programs, according to Sepha.
Building on the company's established Multi-Q leak testing platform, the Sepha Multi-Q HD is a standalone, lab scale leak test system that can be used in combination with interchangeable attachments to fit the full range of parenteral container types in the marketplace currently including glass or plastic vials, ampoules, pre-filled syringes, bottles and Blow Fill Seal (BFS) containers.
The company maintains that its compact, bench-top design means it can be used in the lab during drug development or for in-process batch testing to verify the integrity of containers being manufactured on the production line.
Whilst the Multi-Q HD can be configured to perform a variety of non-destructive, deterministic tests, such as pressure decay, Sepha expects that it will primarily be used for applications which require a vacuum decay test.
The Multi-Q HD allows manufacturers to test in accordance with the ASTM Standard Test Method F2338-09 for vacuum decay in line with FDA consensus and USP 1207 guidelines. This nondestructive and deterministic test method provides quick, reliable and repeatable results without any damage to the product or packaging, said Sepha.
Explaining the context to the development of the new Multi-Q HD, Sepha MD, Paul Smith, commented: “Testing to 5µm used to be the benchmark for CCIT, but in recent years, we have witnessed a drive from the industry to raise the bar for increased integrity test sensitivity. Since the pandemic, this trend has really gained momentum.
“Intercepting defective containers before they reach end-users or patients is important for any pharmaceutical, but for short shelf life, highly sensitive, injectable products it is absolutely crucial.
“Ingress of air through micro cracks and pinholes has implications for product efficacy and safety, therefore pharmaceutical manufacturers cannot afford to be anything less than 100% confident in the integrity of their parenteral formats. We view it as our responsibility to provide the technology that can instill this level of confidence. With this in mind, we set ourselves the target of guaranteeing micro leak detection down to 1µm and we are proud and delighted to report that we have achieved that goal.”
3Brain AG has announced a new technology based on a combination of microchips and artificial intelligence (AI) that promises to change the way drug candidates are selected at the preclinical level to enter into clinical trials.
CorePlate technology allows the harvesting of big data on drug candidates before testing on humans to increase the chance of pharmaceutical success, says the company.
Using this groundbreaking technology, preclinical cell assays are performed in multiwell plates that integrate a microchip in each well to collect rich information from cells, pre-process cell data and streamline it to the paired software. As a result, much more and better data can be extracted, which enables researchers to discover more information about drugs being tested, said the developer.
"We want to radically change the way preclinical drug screening is performed, offering pharmaceutical companies the opportunity to manage their pipelines more efficiently," said Mauro Gandolfo, CEO and co-founder of 3Brain AG. "Basically, we take traditional plastic multiwell plates and we turn them into intelligent devices with multi-core processing power, which can be programmed according to research needs. Integrated intelligence is a remarkable distinction from other instruments in the preclinical space. Importantly, despite the large amounts of data CorePlate devices can process, the user can still easily generate results thanks to the AI-driven interpretation of data. With the CorePlate technology, pharmaceutical companies can save time and money by better filtering and prioritizing drug candidates. Our ultimate goal is to provide our users with tools that help them more readily identify new cures for diseases."
Bio-Rad Laboratories Inc has released three new StarBright dyes designed for flow cytometry applications.
StarBright Violet 570, 670, and 710 dyes were developed to provide improved brightness and precise excitation and emission spectra, with Bio-Rad saying those characteristics make them suitable for use in multicolor flow cytometry panels.
The dyes offer researchers a range of fluorescent nanoparticles conjugated to highly validated flow antibodies, said the life sciences research and clinical diagnostics product developer.
“The new StarBright dyes offer improved brightness when compared to other available dyes at similar wavelengths, and they may be used with a wide range of flow cytometers,” said Mike Blundell, PhD, Bio-Rad product manager, flow cytometry, Life Science Group. “The unique profile of the dyes offers enhanced resolution of rare populations and low-density antigens as well as consistent and reproducible staining.”
The firm outlined what it sees as the key benefits of the dyes:
- They are compatible with new and existing protocols and suitable for use in multiplex panels
- They are resistant to photobleaching and highly stable with minimal lot-to-lot variation
- They offer reliable Förster resonance energy transfer (FRET) for reproducible data
- They work with common staining buffers, including special polymer dye staining buffers, for easy integration into multicolor panels
- They ensure no loss of signal in fixation
- They offer narrow excitation and emission profiles for improved resolution in new and existing multicolor flow cytometry experiments
CytoSMART Technologies has just released two new fluorescence live-cell imaging systems – the Lux3 FL Duo Kit and the Multi Lux3 FL.
The Eindhoven, Netherlands based company says the CytoSMART Lux3 FL Duo Kit is a compact and cost-effective imaging system consisting of two fluorescence microscopes, designed for side-by-side comparison of cell cultures, while the CytoSMART Multi Lux3 FL fluorescence live-cell imaging system consists of four compact Lux3 FL devices, equipped with two fluorescent (green and red) and one brightfield channel, and designed for long-term comparative studies and larger research teams.
Both systems operate from within a standard CO2-incubator or hypoxia chamber, allowing cell analysis in their desired culture environment. Each system of two and four microscopes is connected to a single laptop, maximizing precious laboratory space. Monitoring and analysis of the running experiments can be done via the CytoSMART Cloud, said the technology developer.
Jan-Willem van Bree, CTO at CytoSMART Technologies, commented: "Last year we launched our first fluorescence live-cell imager, the CytoSMART Lux3 FL, and our customers were pleased with its performance and expanded research possibilities. This year we decided to scale up fluorescence live-cell imaging possibilities by launching two new advanced systems: the Lux3 FL Duo Kit and the Multi Lux3 FL. We always aim to develop and offer versatile and flexible solutions to life scientists. For example, the Multi Lux3 FL allows to run up to four individual imaging experiments simultaneously, without affecting the time-lapse imaging experiments of other lab members. This is a very convenient lab equipment for every research group that studies cell viability, co-culture models, single-cell migration, and many other cell-based assays can benefit from it."
The Dutch firm said the main features and benefits of the CytoSMART fluorescence live-cell imaging systems include:
- Ideal for comparative studies – directly compare fluorescently-labeled cell cultures.
- Versatile - expand the number of variables you can examine using fluorescent labeling.
- Flexible – connect devices to the same laptop and control them individually.
- Incubator-friendly – study cells in their desired culture environment.
- Full remote access via the CytoSMART Cloud - no need to enter the lab to inspect cell cultures.
- Indispensable tool for long-term comparative studies – run up to four experiments simultaneously for days or weeks.
- Cost-effective and efficient solution – two or four fluorescence imaging devices connected to one laptop, including unlimited storage and unlimited number of user accounts.
Indica Labs, a provider of quantitative digital pathology and image management solutions, and Ibex Medical Analytics, an expert in the area of artificial intelligence (AI) based cancer diagnostics, announced an agreement to integrate the Galen AI-based cancer diagnostics platform into the HALO AP digital pathology workflow platform.
The integration between HALO AP and the Galen platform is designed to enable a seamless experience for the end-user, said the partners.
Galen adds AI-powered cancer detection, case prioritization, grading and other productivity-enhancing insights displayed directly within the HALO AP Platform, so there is no need to use a separate viewer. Where applicable, the data will be communicated with the LIS or HIS system automatically, they added.
“While Indica Labs continues to grow our state-of-the-art AI application pipeline, we also recognize the importance of interoperability with other leaders in this growing field,” said Steven Hashagen, Indica Labs CEO. “A truly seamless integration with Ibex will allow customers to make best-of-breed AI selections without compromising usability.”
“Integrated digital pathology and AI workflows are a major driver in supporting pathologists, as they are challenged by ever-increasing workloads and complexity of cancer diagnosis,” said Joseph Mossel, CEO and Co-founder of Ibex Medical Analytics. “By joining forces with Indica Labs, we can jointly offer end-to-end solutions enabling pathologists to accelerate adoption of new technologies, strengthen the business case for digitization and improve the quality of cancer care.”
The HALO AP platform can be fully integrated within existing LIS or HIS solutions or can operate as a standalone case and image management system for anatomic pathology, said Indica Labs. HALO AP is used by some of the largest anatomic pathology laboratories in the world, including NeoGenomics and the National Cancer Institute (NCI).
Ibex says its Galen platform uses AI algorithms to support pathologists in improving the quality of cancer diagnosis and providing productivity-enhancing insights that help reduce turnaround times.
Installed in labs worldwide and used as part of everyday clinical practice, Galen, it said, routinely detects misdiagnosed and mis-graded cancers in digitized slides, guiding pathologists to areas of cancer in support of a prompt review.
The company further outlined how, in recent clinical studies, the Galen platform demonstrated outstanding clinical outcomes, including the highest accuracy levels reported in the field for prostate cancer, 1- to 2-day reductions in total turnaround time, and 37% productivity gain for pathologists, compared to conventional microscope viewing.
Lonza had released the 'next-generation' 4D-Nucleofector Platform, what it describes as the leading non-viral cell transfection method for a wide variety of cell types – even those traditionally hard to transfect.
It says the modular design of the new tech offers unmatched flexibility in scale and throughput with proven performance.
This 4D-Nucleofector Core Unit comes with a user experience upgrade for "even more intuitive" experimental setup, added Lonza.
“For more than 20 years, Nucleofector Technology has led the market as the most effective non-viral cell transfection method, which can be used even for hard-to-transfect cells, such as primary cells and pluripotent stem cells. Now, with an updated core unit and even more intuitive software, the next generation 4D-Nucleofector Platform delivers flexibility and the same trusted performance with even greater ease of use."
According to the company, the 4D-Nucleofector Core Unit can operate up to three functional modules, allowing for tailored experimental setups and facilitating scale-up from low to high-volume transfection. In the next generation technology, the family of units is now joined by a fully integrated 96-well unit to suit users with mid-scale transfection requirements for up to 96 samples at once, it added.
In addition, the updated core unit features an 8-inch touchscreen display, enabling users to easily set up their experiments and control all functional modules via the system’s intuitive and user-friendly software, explained Lonza.
Furthermore, optimized protocols are available for more than 750 different cell types and are designed to provide robust transfection conditions, said the company.
