Pharmalutions And Movilitas.Cloud Deliver Serialization Solutions for the Asia-Pacific Region

Movilitas | September 11, 2020

Movilitas announced Pharmalutions Pte Ltd as its newest Movilitas.Cloud partner for the Asia-Pacific region. Under the partnership, Pharmalutions provides greater access to compliance-ready solutions with Movilitas.Cloud, a GAMP 5 validated software as a service solution (SaaS), and their all-European-made Serialization & Aggregation technologies dedicated to the pharmaceutical industry in the region. Their comprehensive portfolio enables companies to comply with global regulations while improving operational efficiencies to deliver safer pharmaceuticals to patients.

Spotlight

The ADVASEPT™ Technology platform provides a glass free primary packaging container that reduces and even eliminates some of the most pressing concerns associated with traditional glass vials.

Spotlight

The ADVASEPT™ Technology platform provides a glass free primary packaging container that reduces and even eliminates some of the most pressing concerns associated with traditional glass vials.

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BUSINESS INSIGHTS

Ablexis and AlivaMab Discovery Services Announce Agreements with Almirall to Accelerate Antibody Drug Discovery and Development

Ablexis, LLC, | January 31, 2022

Ablexis, LLC, a biopharmaceutical company focused on licensing its AlivaMab Mouse technology for antibody drug discovery, and AlivaMab Discovery Services, LLC (“ADS”), a leader in the discovery of superior antibody-based therapeutics, today announced a multi-target licensing agreement between Ablexis and Almirall, S.A. (ALM), a global biopharmaceutical company focused on skin health, and a research partnership between ADS and Almirall. Under the terms of the license with Ablexis, Almirall is granted non-exclusive rights to use the AlivaMab Mouse technology, a state-of-art platform for the generation of human therapeutic antibodies, for the discovery, development and commercialization of antibody drugs. Almirall selected ADS to conduct the drug discovery research, leveraging ADS’ expertise in antibody drug discovery, antibody engineering and platform processes to deliver drug-quality, fully human antibodies on exceptional timelines, including engineering for alternative modalities. “These agreements are in line with Almirall’s vision to develop innovative treatment options for patients suffering from severe skin diseases. AlivaMab Discovery Services’ profound know-how in antibody discovery and engineering together with Almirall's expertise in dermatology will strongly accelerate the development of differentiated treatments to help patients get closer to their goal of leading a healthy life. The agreements highlight the company's commitment to early biologics discovery to provide the best solutions to skin conditions through novel science.” Dr. Thomas Huber, Research Director at Almirall "We are pleased that Almirall has selected the AlivaMab Mouse technology as a key platform for its antibody drug discovery," said Larry Green, Chief Executive Officer at Ablexis, LLC. "Together with the talented and highly experienced team of antibody drug hunters at Ablexis' sister company, AlivaMab Discovery Services, we are increasingly recognized by partners with real experience in antibody drug discovery and development.” “Almirall joins our rapidly expanding list of high-quality partners that leverage the discovery, engineering and developability assessment capabilities of ADS, especially for challenging targets, functional design goals and advanced modalities,” said Justin Mika, Chief Executive Officer at AlivaMab Discovery Services. “Our partners appreciate how our team’s expertise, combined with the proven AlivaMab Mouse platform, significantly improves the probability of success and shortens timelines in discovery and development. We look forward to supporting Almirall’s efforts to help patients with dermatological conditions.” About Ablexis, LLC Ablexis, LLC created and non-exclusively licenses AlivaMab Mouse, a suite of unique, patented next generation transgenic mice, as a platform for human therapeutic antibody discovery. Ablexis has license agreements with dozens of companies, including global pharmaceutical companies, public and private biotechnology companies and other entities. Ablexis continues making AlivaMab Mouse available via non-exclusive licenses. About AlivaMab Discovery Services AlivaMab Discovery Services (ADS) sets its partners’ antibody discovery programs on the fastest and most de-risked path through discovery and development. Trusted by top-tier pharmaceutical and biotechnology companies, ADS delivers drug-quality, fully human antibodies on exceptional timelines. ADS achieves its partners’ design goals, from simple to extraordinarily challenging, through the generation and function-first screening of large, molecularly diverse panels of antibodies. ADS focuses on rapid and efficient delivery of antibodies, characterized for function, kinetics and developability, and engineering for advanced modalities, including multispecifics and CARs. The ADS team’s experience in antibody drug discovery and development comes from many of the world’s top 15 pharmaceutical companies, including AbbVie, AstraZeneca, Bristol Myers Squibb, Novartis, Pfizer and Roche/Genentech, and translates across more than 500 discovery programs and 35 clinical candidates. This experience, combined with the use of trusted, proven technologies, including Ablexis’ AlivaMab® Mouse platforms, ensures the highest probability of success. About Almirall Almirall is a global biopharmaceutical company focused on skin health. We collaborate with scientists and healthcare professionals to address patient’s needs through science to improve their lives. Our Noble Purpose is at the core of our work: “Transform the patients' world by helping them realize their hopes and dreams for a healthy life”. We invest in differentiated and ground-breaking medical dermatology products to bring our innovative solutions to patients in need.

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PHARMA TECH

Innovation Zed Announce 2022 Launch of InsulCheck DOSE Add-on Technology for Insulin Pens

Zed | November 15, 2021

Innovation Zed, developer of novel diabetes management technologies headquartered at NovaUCD, at University College Dublin, Ireland are delighted to announce today the arrival of the much anticipated InsulCheck DOSE technology that will be coming to market in 2022. "It is with great excitement that we announce the arrival of our InsulCheck DOSE by Innovation Zed. As the third generation product of the InsulCheck family, this technology has been a dream of our company from its very inception and this product is the culmination of over a decade of work to support multiple daily injection (MDI) pen users. We understood the difficult challenges presented by various injection pens and in particular the difficulties in working on a technology to reliably and accurately support low-cost disposable pens. This is the reason we at Innovation Zed took an incremental approach to developing the InsulCheck DOSE product.We have taken a unique approach in developing this technology by working closely with users, caregivers, software developers, medical device specialists and previous generations of InsulCheck products to design and develop a product that bolsters and supports the needs of all stakeholders.'' Dr Dean Minnock, CEO at Innovation Zed Innovation Zed has collaborated with SHL Medical in the development of InsulCheck DOSE. SHL Medical is a world-leading provider of drug delivery solutions and also offers design-to-build and contract manufacturing services for various medical products through its subsidiary, SHL Technologies. What is InsulCheck DOSE? InsulCheck DOSE is a single unit add-on device for pen injectors that automatically captures dose value dialled, injection event time stamp, temperature and mounting/unmounting events. Through Bluetooth® Low Energy (BLE) technology, InsulCheck DOSE transmits these data points to a paired companion software platform in real time for inclusion in diabetes management therapy. "InsulCheck DOSE technology supports MDI users by enhancing their traditional injection pen and transforming it into a smart pen that can optimise their treatment and reduce the stresses caused by MDI therapy. Through this technology we are enabling every MDI user to make their existing injection pen a smart pen without having to compromise or change from their existing HMO or health service provider" - said Dr Minnock. InsulCheck DOSE Features The technology utilises a multi-sensor approach to accurately detect and register the actual dosage dialled and provide an injection event time stamp to log the event. The incorporated temperature sensors constantly monitor the ambient temperature of the area surrounding the injection pen, providing safety notifications to the user if the surrounding temperature may affect the drug housed inside the pen. Using an OLED display, InsulCheck DOSE provides visual information and feedback to the user, helping improve best practice procedures. A rechargeable lithium battery powers the DOSE device and is capable of operating well over 1 week at a time between charges. As a BLE enabled product, all data captured by InsulCheck DOSE is transferred in real time to a paired mobile application. If the user does not wish or is unable to remain connected with a companion software platform, InsulCheck DOSE has built-in memory to store over 40 days' worth of injection history at a time. Through modification of the sleeve component and firmware refinement, InsulCheck DOSE can become applicable to all injection pens for various drug treatments. At launch, it will support a range of reusable and disposable injection pens on the insulin market from Novo Nordisk, Lilly and Sanofi. "Our ability to learn, adapt and improve our technology is one of the key aspects of InsulCheck DOSE and one that separates us greatly from our competitors. The future-proof design of InsulCheck DOSE means that it can be adapted to support the various pen mechanisms in use today, whilst maintaining accuracy and reliability for the patient. Among the numerous unique features of this product is the built in Firmware Over The Air (FOTA) capability which allows continuous optimisation of the device's firmware even when deployed in the field. That future-proofing allows InsulCheck DOSE to adapt to physical injection pen variations from the pen manufacturers and improve on device performance 'on the go' from real world user behaviours" - said Dr Minnock. Value Proposition The InsulCheck DOSE device helps patients, automatically track their daily injection and monitor treatment adherence. The intended use of InsulCheck DOSE is as a supporting component in a management ecosystem for therapy optimisation, remote monitoring and enhanced connected care. Dr Minnock explained, "InsulCheck DOSE is a disruptive technology that will revolutionise an entire market and change the lives of millions of MDI users worldwide. Innovation Zed have entered into discussions with market leaders in the diabetes management sector with the intention of finding a strategic global partner in taking this InsulCheck DOSE technology to the market. InsulCheck DOSE is an attractive offering to any organisation working in this space as it can significantly enhance their existing offering to become more competitive and command new growth and additional market share." Conclusion InsulCheck DOSE enters production at the end of Q2 2022 and will be available as an FDA registered and CE marked product. Manufacturing of InsulCheck DOSE will be handled by Innovation Zed's existing manufacturing partner SHL Technologies, a subsidiary of SHL Medical. If you wish to understand InsulCheck DOSE or any of our technology offerings in greater detail, please feel free to visit our website or reach out to us directly.

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RESEARCH

Biognosys Launches Next-Generation Blood Biomarker Discovery Solution

Biognosys | November 10, 2021

Biognosys, a leader in proteomics solutions for drug discovery and development, announces the launch of its next-generation blood biomarker discovery solution, which will be offered as a contract research service. The service is designed to help researchers decipher the complexity of the blood proteome and unlock unbiased discoveries for pharma and diagnostics development and precision medicine. The launch will feature a series of events and resources that detail the science and technology behind the new solution, as well as its applications Launch webinar on November 9, entitled: “Plasma Proteomics: The Next Frontier of Biomarker Discovery in the Precision Medicine Era.” Presentation and exhibition at the Society for Immunotherapy of Cancer (SITC) Annual Meeting on November 12-14 in Washington, D.C. The new service offers unprecedented depth, quantitative precision, and throughput for discovery research. The solution will search the complete plasma proteome to quantify up to 3,000 of the most relevant proteins and measure tens of thousands of peptide-level datapoints to provide a deep understanding of key disease pathways. The solution can be applied across all biological species and to any other biofluid, such as cerebrospinal fluid or urine. In addition to the biofluid biomarker discovery service, an improved tissue biomarker discovery service is available, offering an industry-leading depth of 10,000 proteins. Both solutions are based on Biognosys’ proprietary, patented Hyper Reaction Monitoring (HRM™) technology and its optimized Liquid Chromatography - Mass Spectrometry (LC-MS) workflow. The clinical transferability of this technology allows quick transition from early stage discovery to specific, targeted panels that can be applied in a regulated setting. Kanna Palaniappan, PhD, Staff Scientist at Freenome, a company that develops blood tests for early cancer detection, powered by a multi-omics platform, testifies: “We have used Biognosys’ services for a number of biomarker discovery studies focused on improving cancer detection, taking advantage of their constantly improving platform, and their ability to run large-scale studies while maintaining high data quality. We have had a valuable and productive relationship and we look forward to future collaborations.” “We are thrilled to offer customers our innovative, next-generation biomarker discovery solution and enable them to gain biological insights beyond what pre-defined panels can provide. By diving deep into the plasma proteome with an unbiased view, we profile the proteins that are of highest relevance to our customer’s disease areas of focus. This is what we call true discovery.” Kristina Beeler, PhD, Chief Business Officer of Biognosys Lukas Reiter, PhD, Chief Technology Officer of Biognosys states: “Mass spectrometry-based proteomics is the ideal tool to explore the blood proteome in an unbiased manner. Our continuous R&D improvements have enabled us to reach an unprecedented depth to quantify the very low abundant protein ranges that are of highest biological significance, while ensuring high scalability for clinical research.” About Biognosys Biognosys is a leader in next-generation proteomics, dedicated to transforming life science by inventing and developing cutting-edge proteomics technology and solutions and making them widely available for pharmaceutical and biotechnology researchers and proteomics experts. The Company offers a versatile portfolio of proprietary proteomics services, software, and kits that provide a multi-dimensional view of protein expression, function, and structure in all biological species and sample types. Biognosys’ unique, patented technologies utilize high-resolution mass spectrometry to quantify thousands of proteins across thousands of samples with industry-leading precision, depth, and throughput. Through advanced data analytics, Biognosys translates data into actionable insights for R&D and clinical research.

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