CEM Corporation | September 16, 2021
CEM Corporation and AmbioPharm, Inc. are pleased to announce the formation of a partnership to produce GMP peptides for the global market. The partnership includes the exclusive 1Use of CEM's microwave peptide synthesis technology on a large scale for the production of GMP peptides up to several kilograms using its own scalable reactors. The main advantages of this new relationship are the extremely short production times, the ability to efficiently produce more difficult peptide sequences, and the ability to incorporate green chemistry protocols. This partnership will enable the rapid and efficient production of new chemical peptide entities (NCEs) using the latest available technologies. With this agreement, AmbioPharm has started peptide synthesis at its North Augusta facility to better serve customers with fast microwave synthesis processes.
CEM's peptide production technology utilizes automated, large-scale microwave solid phase peptide synthesis systems (SPPS) that have been proven to improve peptide purity and minimize excess reagents. In addition, the CEM has developed proprietary coupling methods optimized for reactions at elevated temperatures 2 , a unique way to combine the coupling and deprotection reactions in a single step 3 , and established the use of more environmentally friendly solvents that are more accessible at elevated temperatures 4 . These unique technological advantages are licensed to AmbioPharm for GMP production.
AmbioPharm is a recognized leader in cGMP peptide production. The company employs more than 675 people and recently completed a major expansion of its headquarters in South Carolina, USA, adding nearly 56,000 square feet of additional peptide manufacturing capacity. The production plant has a cleaning capacity of up to 30 kg / batch and a freeze-drying capacity of up to 1,000 liters. The CEM Liberty Pro Synthesizer offers different reactor sizes (3, 8 and 15 liters) that allow the synthesis of batches from 5 g to 500 g of the final peptide.
Peptide-based drugs have enormous potential for the future and we are pleased to be able to help improve their production process. AmbioPharm is an ideal partner and we believe this relationship will enhance the opportunities for the manufacturing of peptide therapeutics.
- Michael J. Collins, Ph.D., President and CEO of CEM Corporation.
With the addition of CEM's microwave technology to our GMP peptide manufacturing options, we can offer even better service in terms of faster delivery for our partners' products and unique opportunities to make longer and more complex peptides accessible using microwave methods.
- Chris Bai, Ph.D., CEO of AmbioPharm Inc.
CEM Corporation, a privately held company based in Matthews, North Carolina, is a leading provider of laboratory instruments. The company has subsidiaries in the UK, Germany, Italy, France, Japan and Singapore and a worldwide network of distributors. CEM designs and manufactures systems for life sciences, analytical laboratories and processing plants worldwide. The company's products are used in many industries, including the pharmaceutical, biotech, chemical and food industries, as well as academic research.
About AmbioPharm, Inc .
AmbioPharm, part of the Ambio Pharmaceuticals Group, is a leading, innovation-driven company that specializes in the development and manufacture of peptides and peptide-like products. AmbioPharm offers a comprehensive range of services and produces customized products for research, clinical development and commercial use for pharmaceutical and biotechnology companies worldwide. AmbioPharm operates internationally, has its headquarters in the USA, locations in Europe, the USA and Asia and has more than 14 years of experience and expertise.
Innovation Pharmaceuticals, Fox Chase Chemical Diversity Center | July 23, 2020
Innovation Pharmaceuticals, a clinical stage biopharmaceutical company, announces today that the Company and Fox Chase Chemical Diversity Center, Inc. have amended an earlier collaborative research agreement related to antifungal drug discovery work.
Under the amended terms, and in exchange for a six (6) percent fee tied to all potential future proceeds—including upfront payments, milestone payments and royalties—the Company is granting FCCDC all discovery, intellectual property and commercialization rights related to its share of their joint antifungal drug program. Both parties believe the new agreement is favorable to each, with FCCDC continuing to advance discovery and drug development, and Innovation Pharmaceuticals benefiting from potential future commercialization. Over $5 million in government grants have helped fund antifungal work conducted to date.
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.
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."
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.