BUSINESS INSIGHTS

NanoPass and M2N enter strategic development & foundry agreement

NanoPass; M2N | December 23, 2021

NanoPass Technologies and Micro2Nano have reached an agreement to enter a strategic development and production relationship for the design and production of NanoPass's proprietary MEMS based microneedles.

The aim of the collaboration is to strengthen the relationship between NanoPass and M2N and provide a basis for the continued growth of the two comaim of the collaboration is to strengthen the relationship between NanoPass and M2N panies while basing the new agreement on years of development and production collaboration.

M2N has been an integral and inseparable part of Nanopass's development and manufacturing capabilities since 2007 and has been providing Nanopass with high quality foundry services, ingenuity and quick turn-around on development projects.

NanoPass's proprietary technology platform is based on hollow, pyramid-shaped, microneedles. It is produced from silicon crystal using MEMS technology. The technology can be used for intradermal delivery of a wide range of injectables including vaccines and therapeutics, aesthetics, cosmetics and more.

"M2N has been developing and manufacturing MEMS based microneedles with NanoPass for more than 14 years. It's an amazing thing considering the average lifespan of a company in recent years. During this long period of time, we have built a strong business relationship on the basis of trust. We are excited to provide high quality microneedles to NanoPass as a Prime Manufacturer and to support NanoPass in developing the new business applications as a Strategic R&D Partner."

Kyuho Hwang, CEO of Micro2Nano 

Yotam Levin, MD, CEO of NanoPass, added, "M2N has been a trusted partner for over a decade and has been assisting NanoPass regularly with both its development projects and ongoing commercial production. M2N provides ongoing high-quality products, has a quick response time, and finds ingenious ways to solve complex problems. For us, trust is a key parameter for any partner, and M2N's organizational culture provides just the thing."

About M2N
M2N has been providing MEMS foundry service since its foundation in 2000. Profound experience and knowhow with MEMS processes enables M2N to co-work with multiple companies for developing new products and provide mass production services based on MEMS technology. Additionally, M2N has developed its own product line including MEMS probe cards for semiconductor wafer testing and MEMS sensors. 

About NanoPass
NanoPass is a pioneer in the development and commercialization of microneedle-based delivery platforms for aesthetics, vaccines and more. MicronJet®600 is FDA 510k cleared, CE marked and has regulatory approval in Russia, Brazil, South Korea, China and more. It is supported by extensive clinical data and approved for the delivery of any substance or drug under the surface of the skin that is approved for this delivery route.

Spotlight

Plasmodium falciparum resistance to artemisinin-based combination therapies (ACTs) started to crop up around 2007. Infections, especially in the Greater Mekong area of Southeast Asia, seemingly survived treatment. This was largely due to the pairing of artemisinin derivatives with older drugs that had existing resistance problems. But some experts think the emergence of partial resistance to artemisinin itself which allows parasites to persist for longer in the body following treatment could also play a role.

Spotlight

Plasmodium falciparum resistance to artemisinin-based combination therapies (ACTs) started to crop up around 2007. Infections, especially in the Greater Mekong area of Southeast Asia, seemingly survived treatment. This was largely due to the pairing of artemisinin derivatives with older drugs that had existing resistance problems. But some experts think the emergence of partial resistance to artemisinin itself which allows parasites to persist for longer in the body following treatment could also play a role.

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PHARMACY MARKET

Virpax Announces MMS019 Manufacturing and Supply Agreement

Virpax Pharmaceuticals | August 27, 2021

Virpax® Pharmaceuticals, Inc., a company specializing in developing product candidates for pain management, CNS and anti-viral indications, today announced that it has entered into a commercial manufacturing and supply agreement with Seqens, an integrated global leader in pharmaceutical solutions with 24 manufacturing sites worldwide and seven research and development facilities throughout the U.S. and Europe. The agreement with Seqens provides for both the supply material for Virpax’s clinical studies as well as the long-term commercial supply of MMS019. Seqens will conduct process development and validation of additional large scale commercial quantities of MMS019 at its facilities in Devens and Newburyport, Massachusetts. “Establishing a collaboration with a strong partner capable of supplying clinical and commercial scale quantities of MMS019 is another important advancement in our MMS019 product development strategy. Seqens has a demonstrated expertise in developing and manufacturing highly-complex molecules for large scale production,” said Anthony Mack, Chairman and CEO of Virpax. “Importantly, we expect this collaboration to support future development and supply additional Molecular Envelope Technology programs under development, including Envelta™ and PES200, our post-traumatic stress disorder product candidate,” concluded Mr. Mack. About MMS019 MMS019 is a drug product candidate based on a type of nanotechnology that enables the exclusive delivery of a metabolically labile peptide drug into the brain via intranasal delivery. MMS019 is manufactured using industrially relevant equipment and processes (high pressure homogenization and spray drying). There is pharmacological evidence of activity of molecular envelope technology (MET) enabled enkephalin in morphine-tolerant animals. The MET nanoparticles are well tolerated via the nasal route at the dose administered. MMS019 demonstrated comparable preclinical activity to morphine in all animal pain models tested without the drug seeking and tolerance associated with opioids. About Seqens SEQENS is an integrated global leader in pharmaceutical solutions and specialty ingredients. With 24 production sites and 7 R&D centers in Europe, North America and Asia, SEQENS develops and manufactures tailor-made solutions and ingredients for the most demanding industries such as healthcare, electronics, cosmetics, food and home care. Driven by a culture of excellence and a strong entrepreneurial spirit, our 3,200 employees are committed to providing our customers with the highest level of service and quality while acting ethically in accordance with our corporate social responsibility program.” About Virpax Pharmaceuticals Virpax is developing branded, non-addictive pain management product candidates using its proprietary technologies to optimize and target drug delivery. Virpax is initially seeking FDA approval using its three patented drug delivery platforms. Epoladerm™ is a topical diclofenac metered-dose spray film formulation being developed to manage acute musculoskeletal pain and osteoarthritis. Probudur™ is a single injection liposomal bupivacaine formulation being developed to manage post-operative pain. Envelta™ is an intranasal molecular-envelope enkephalin formulation being developed to manage acute and chronic pain, including pain associated with cancer. Virpax is also using its intranasal Molecular Envelope Technology (MET) to develop its PES200 product candidate to manage post-traumatic stress disorder (PTSD) and its MMS019 product candidate to inhibit viral replication caused by influenza or SARS-CoV-2.

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PHARMACY MARKET

Bushu Pharma's Partnership with Suzuken Group Increases Specialty Pharmaceutical Services

Bushu Pharmaceuticals Ltd. | April 28, 2021

Bushu Pharmaceuticals Ltd. has entered into a business partnership arrangement with Suzuken Co., Ltd. to provide specialty pharmaceutical producers looking to enter the Japanese market with extensive support for new product releases. In recent years, the market has seen an increase in the number of innovative specialty pharmaceuticals, such as biopharmaceuticals, regenerative medicines, and orphan drugs for rare diseases, that require strict temperature, inventory, and security control. In line with this trend, the number of pharmaceutical companies planning to bring these types of drugs to Japan has grown. These pharmaceutical manufacturers, on the other hand, often lack the necessary infrastructure, such as production facilities, delivery centers, and networks, to reach the Japanese market with minimal resources, and must therefore outsource these functions to trusted partners. Suzuken, Bushu Pharma's partner, has played an industry-leading role in Japan's pharmaceutical distribution market. Suzuken, one of the leading organizations in the industry, has a distribution network in Japan capable of supporting the international shipping of specialty pharmaceuticals. Bushu Pharma, on the other hand, has been in the contract manufacturing industry in Japan for over 20 years, holds GMP certifications from all over the world, and has a track record of exporting to over 43 countries. Bushu Pharma will establish a platform that provides one-stop holistic assistance for pharmaceutical producers seeking to penetrate the Japanese market by aligning functions and capabilities with Suzuken. About Bushu Pharmaceuticals Ltd. Bushu Pharma manufactures solid reparations, solid preparation primary packaging, injection manufacturing, and injection packaging not just for domestic pharmaceuticals but also for multinational pharmaceutical manufacturers, drawing on its expertise and understanding as a contract development and manufacturing organization (CDMO) cultivated over 20 years. Bushu Pharma has a diverse product and service offering, ranging from clinical trial supplies to commercial product development support to commercialization, as well as various production facilities and technologies. Bushu Pharma is a leading domestic contract manufacturing company in Japan that can offer optimum solutions such as technology transfer, production, packaging, and logistics from project start to project approval.

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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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