Pharmaceutical Technology Editors

Sepha’s EZ Blister+ is a compact small-batch blister packaging machine with a software architecture that has demonstrated compliance with 21 Code of Federal Regulations Part 11. The EZ Blister+ is built to deliver small batches of drugs and medical devices with electronic signatures, batch reports, audit trails, and other forms of electronic documentation. 

The blister trays are either thermoformed or coldformed, sealed with pre-cut pieces of lidding material using knurled or flat-heated sealing plates, and then cut and perforated using a precision die-cutter. The EZ Blister+ can package tablets, capsules, ampoules, and various other products.

Additionally, the machine’s structured query language database system powers various functions while also facilitating integration with factory networks and management execution systems.

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Sepha’s EZ Blister+ is a compact small-batch blister packaging machine that is 21 CFR Part 11 compliant.

Small-Scale Blister Packaging Machine

Tower Cold Chain’s KTEvolution is a temperature-controlled container designed for the transportation of pharmaceuticals as well as lifescience and biotech products. It has similar thermal protection and reusable durability to Tower’s existing range of containers but is intended to be a lightweight solution that can be carried by one-to-two people. 

The product has demonstrated 120+ hours of thermal insulation without the need for external power or human intervention. It comes in 26 L and 57 L varieties and is ideal for products that require an internal temperature of -70 °C to +20 °C. According to data from over 25,000 shipments, it has demonstrated fewer than 0.1% temperature excursions. 

The KTEvolution has minimal fixtures and fittings, instead using a light-weight webbing system and integral handles to evenly distribute the load and simplify the manual handling process. It features built-in datalogging technology that can provide real-time confirmation of internal temperature and on-delivery sign-off; it is also compatible with smart technology solutions that allow for location, shock, and impact monitoring.

The KTEvolution from Tower Cold Chain is a lightweight, reusable container designed for the transport of pharmaceutical products. 

Pharmaceutical Transport Container

ROSS has incorporated a high shear rotor/stator into its Dual-Shaft Mixer to meet more intense shearing and homogenization requirements. 

Rather than including a typical highspeed disperser blade, the mixer comes equipped with a rotor and slotted stator mixing head, also called a homogenizer, for more advanced deagglomeration and emulsification capabilities. The product also features a two-wing anchor that promotes bulk flow and uniform batch temperature. 

The ROSS Model CDA-25 (pictured) includes dry-running Double FlexiLip seals on both agitator shafts, making it appropriate for vacuum operations up to 29.5” Hg. This model also features a portable mixing vessel with a heating/cooling jacket.

ROSS incorporated a high shear rotor/stator into its Dual-Shaft Mixer to meet more intense shearing and homogenization requirements.

Dual Shaft Mixer with High Shear Rotor/Stator

In April 2022, Bio-Rad Laboratories introduced three new StarBright Dyes: StarBright UltraViolet 510, StarBright UltraViolet 665, and StarBright UltraViolet 795. These dyes are designed for use with a 355-nanometer ultraviolet (UV) laser in flow cytometry applications. StarBright UltraViolet 510, 665, and 795 dyes were designed to offer enhanced brightness with narrow excitation and emission profiles, allowing for precise resolution.

The StarBright line of dyes offers researchers unique fluorescent nanoparticles conjugated to highly validated flow antibodies, which are compatible with most experimental protocols and flow cytometers, including Bio-Rad’s ZE5 Cell Analyzer and S3e Cell Sorter, according to the company’s April 19, 2022 press release. The dyes are resistant to photobleaching and are highly stable with no loss of signal in fixation. Furthermore, the dyes minimize lot-to-lot variation, which helps to ensure consistent staining and reliable results.

“We are proud to add three new dyes to Bio-Rad’s StarBright UltraViolet portfolio, following its launch last year, and are now better positioned to support researchers with their flow cytometry workflows by providing a range of high-performance dyes excitable by the 355 nanometer UV laser to existing alternatives,” said Mike Blundell, PhD, product manager, flow cytometry, Life Science Group, Bio-Rad, in the press release. “The unrivaled brightness of the dyes enables enhanced resolution of low-density antigens and rare populations while maintaining consistent and reproducible staining without the need for special buffers.”

Bio-Rad Laboratories introduces three new fluorescent dyes under the StarBright product range to support multicolor flow cytometry panels.

Bio-Rad’s Three New Fluorescent Dyes are Intended to Enhance Multiplex Flow Cytometry

Arrayjet, a provider of inkjet liquid-handling solutions, launched Mercury, a new core range of five instruments for ultra-low-volume liquid dispensing, in April 2022. According to the company, these new print dispensers offer high functionality and reliability as well as optimal speed and precision. The company offers them in a range of output capacities from 25 to 1000 slides. The instruments can be used for a wide range of microarray and microfluidics applications in pharmaceutical workflows as well as for diagnostic and life science applications.

This range of instruments has been designed to be compact and to have tight environmental controls for printing consistency. The new design is intended to have an easy set-up as well as be user-friendly and simple to maintain. The instruments incorporate a new printhead range that offers faster and more accurate printing of a larger range of volumes and spot sizes.

In addition, advanced capabilities can be custom-tailored or chosen from six application-specific packages comprising printing, scanning, reagents, and substrates, which enable users to access the most relevant functionalities. Furthermore, Mercury is upgradeable and scalable to meet growing manufacturing or research requirements and is fully compatible with future developments from Arrayjet, according to the company in an April 4, 2022 press release.

Arrayjet’s high-speed microarray printers use patented, non-contact inkjet technology for printing multiplex array-based assays onto slides, point-of-care devices, biochips, and microplates. The technology is versatile and can print any biological sample onto any substrate. The Mercury range offers cost-effective, higher-throughput arraying with in-line quality control and requires minimal manual input, according to the company in its press release.

“With the launch of Mercury instruments, our offering is stronger than ever. The new range comprises the fastest and highest throughput microarrayers on the market; helping our customers to reduce costs, save time, and minimize reagent use,” said Iain McWilliam, CEO of Arrayjet, in the press release. “This range incorporates our multidisciplinary team’s assay development expertise and innovation, alongside valued customer feedback, showcasing Arrayjet’s continued dedication to advancing microarray printing.”

A new range of five instruments for ultra-low-volume liquid dispensing for microarray and microfluidics applications, Mercury, has been introduced by Arrayjet.

Arrayjet Launches New Range of Next-Generation Microarray Printers

On April 26, 2022, CN Bio, an organ-on-a-chip (OOC) company, announced the launch of its PhysioMimix “in-a-box” reagent kit for non-alcoholic steatohepatitis (NASH)—a disease that, to-date, has no regulatory-approved therapeutics for treatment because of the inability to predict human responses to this complex disease via traditional 

The NASH-in-a-box (NIAB) kit works in conjunction with CN Bio’s PhysioMimix microphysiological systems (MPS) to provide researchers with in-house capabilities to gain physiologically relevant insights into the mechanism of disease, human drug efficacy, and safety toxicology. The assay addresses the human-relevance limitations of existing approaches, allowing scientists to bridge the gap between human 2D cell culture and expensive animal models, the latter of which have been ineffective in mimicking the full disease spectrum. This connection enables NIAB kit users to generate clinically translatable and predictive data to gain more insightful, accurate, and cost-effective drug development, according to a company press release.

Through the “in-a-box” product range, CN Bio aims to fast-track the incorporation of MPS into drug discovery workflows by providing a straightforward and quick route to recreating OOC assays. The NIAB kit includes a simple-to-follow, software-based protocol for users to allow them to successfully co-culture internally validated primary human hepatocytes, stellate, and Kupffer cells. The protocol enables the formation of 3D microtissue structures that accurately emulate the microarchitecture of the human liver. By introducing fatty acids, researchers can thus recapitulate key non-alcoholic fatty liver disease/NASH disease states, including intracellular fat accumulation, inflammation, and fibrosis. The model enables the investigation of the precise mechanistic effects of drugs (of any modality) and disease via high-content, clinically translatable end-point measurements, according to the company in the press release.

“NASH-in-a-box enables CN Bio to expand our market reach from those who prefer to outsource their testing to our laboratories to those who would rather develop in-house capabilities. As the first in our ‘in-a-box’ range, the launch of the NASH kit represents a significant step towards the widespread adoption of [o]rgan-on-a-chip technology within the drug discovery industry. Consequently, we believe this product will enable discovery programs targeting this disease, which is a large and growing burden on healthcare systems, yet lacks any approved therapies,” said David Hughes, CEO, CN Bio, in the press release.

“This new product demonstrates the full advantages of our microphysiological systems, providing scientists with access to easy-to-use, yet best-in-class liver models in their own labs, streamlining the process and making it far quicker and more cost effective. We believe this will allow for more thorough and accurate testing during the drug development process, which will increase the likelihood of much-needed new NASH drugs to make it to market,” said Ovidiu Novac, senior scientist for CN Bio, in the press release.

CN Bio’s PhysioMimix “in-a-box” reagent kit is designed to harness liver-on-a-chip technology to improve accuracy and efficiency in drug discovery.