This month’s roundup of new equipment, materials, tech partnerships, and other news includes items from Ajinomoto, Evonik, Quanticate, Pharmasol, and more.
This month’s roundup of new equipment, materials, tech partnerships and other news includes items from Ajinomoto, Evonik, Quanticate, Pharmasol, and more.
The contract development and manufacturing organization plans to open a high-speed, multi-purpose fill finish line at its San Diego manufacturing facility. The new line will offer a range of configurations, including prefilled syringes, cartridges and vials.
“This expansion provides a significant increase in our current aseptic fill/finish capacity and allows for additional scheduling flexibility, as well as component flexibility,” commented Paul Ruther, director of drug product manufacturing for Ajinomoto Bio-Pharma Services. “Our continued investment in increasing capacity further enhances Aji Bio-Pharma’s commitment in being a leading global and quality-driven CDMO with comprehensive service offerings.”
Smart Meter has launched its iScale cellular-connected body weight scale. The remote patient monitoring device, which enables clinical researchers to track a key metric from a distance, joins the company’s devices for remote diabetes and blood pressure monitoring.
According to the company, the iScale offers a number of built-in features designed to offer a combination of effective weight tracking and positive user experience. The device offers cellular connectivity, large footprint, 4-inch LCD display, and ability to measure weights up to 551 lbs (about 250 kg).
The new Eudracap platform consists of capsules designed to be easy to handle, geared toward complex oral drug products in early development stages. The Eudracap enteric, the first product in the line to be launched, is an enteric coated pre-locked capsule designed to optimize gastric resistance, boost intestinal absorption and enhance bioavailability.
“Eudracap is our answer to many of the challenges innovators in the pharmaceutical industry are facing when pioneering oral drug products,” commented Axel Schröder, head of global business segment oral drug delivery solutions at Evonik Health Care.
The Aria Smart Autoinjector platform consists of a ‘smart’ injection device with a reusable electronic drive unit, and single-use disposable cassettes. The product is intended to help users deliver improved patient care and reduce environmental impact.
“With the Aria Smart Autoinjector, we are disrupting this sector with a game-changing platform that brings the right functionality to market in the right form factor at the right time,” said Kevin Deane, vice president of innovation at Phillips-Medisize. “Our goal from the outset has been to develop an injector that patients love, combining the simplicity of current disposable devices with the superior performance, sustainability and connectivity possible through an electronic, reusable device.”
The clinical research organization has launched its Remote Source Data Verification (RSDV) platform. According to the company, the 21 CFR part 11 compliant cloud-based application allows verification of source data from multiple sites to be completed remotely by a specialist team at a centralized location.
David Underwood, CEO and chairman at Quanticate, said, “Throughout the COVID-19 pandemic, there have been significant challenges for clinical trial sponsors and sites alike resulting in renewed emphasis on creating remote approaches to improve efficiencies and adapt to travel restrictions. Our new RSDV platform will help to ensure that our customers operate more efficiently and safely while delivering clinical trial data with high integrity.”
The latest version of Pharmasol’s data communication hub for drug-safety document management, psiXchange 2.4, automates safety document distribution within clinical trials. Enhancements include expanded site views, and information that can be shared in real time with recipients along the drug safety management chain.
Tim Billington, Pharmasol’s chief sales officer, said, “This new version of psiXchange builds on its existing automated distribution process, which eliminates the need for expensive set-up costs for each new study by reducing or eliminating manual efforts. The hub effortlessly integrates with existing systems, safeguarding investigators, study teams and compliance personnel from potential implementation headaches.”
The Arium Smart Station is designed for dispensing pure and ultrapure water from the company’s Comfort and Pro water systems, and its line of bagtanks. The technology is intended to enable laboratory personnel to dispense water in the precise quantities needed, where and when needed.
“Lab and bench space is always at a premium and that was an essential consideration when we designed the Arium Smart Station,” said Nadia Brandes, lab water product manager at Sartorius. “In addition to being compact, the stations have an ergonomic design, an intuitive display and offer flexible height adjustment to fill even the largest vessels.”
The two companies announced plans to collaborate on ways to jointly advance nanoparticle-enabled drug delivery. According to the firms, their goal is to assess the utility of combining Nanoform’s nanoparticle platform technologies with Celanese’s VitalDose EVA copolymer delivery technology for drug-eluting implants.
Edward Hæggström, CEO of Nanoform, said, “Given the inherent difficulty in loading a sufficient amount of drug into many medical devices, we see a tremendous opportunity in using our nanoparticles to overcome this fundamental challenge. The potential to leverage the combination of these two technologies to bring new therapies to patients is something we are very excited about.”
The MOBIE high-resolution ion mobility (HRIM) system is intended to help lab staff accelerate development of biotherapeutic drugs as well as multiomic biomarker discovery. According to the manufacturer, the device is able to offer fast, efficient separations with better resolution and reproducibility; faster, simpler method development; and greater instrument uptime than similar devices.
“MOBIE can not only separate and identify molecules other instruments fail to detect, but it achieves superior performance with rapid analysis times, more efficient analyte-agnostic workflows, and more reproducible results, making it ideal for routine analysis,” said Melissa Sherman, CEO of Mobilion Systems.
Virtual research organization ObvioHealth is collaborating with life-sciences software specialist Dedalus Group. The partnership will merge ObvioHealth’s decentralized trial tools and Dedalus’s software products in an effort to make connections between research and EHR data.
Ivan Jarry, CEO of ObvioHealth, said, “The integration of clinical research with the data that sits within EHRs has the potential to be a game changer. Dedalus and ObvioHealth are enabling more precise identification of cohorts for trials while also facilitating longitudinal analyses that can identify new indications and/or long-term impacts of certain treatments.”
