Investment Set to Spur Oral Medicines Growth


CDMO and full service provider Hermes Pharma is investing a further €25 million in its manufacturing capabilities, arming the company with new equipment, increased production and storage capacity, as well as greater operational effi ciency to meet the rapidly growing market demand for user-friendly oral dosage forms. The investment forms part of the company’s strategy to drive future growth, while helping new and existing customers to realise theirs.


The pharmaceutical industry has long seen traditional tablets and capsules as the ‘gold standard’ of oral dosage forms. However, studies suggest that around 50% of people struggle to take them. Consequently, demand for easy-to-swallow oral dosage forms, such as orally


disintegrating Andreas Ulrich granules (ODGs), chewable


tablets, lozenges, instant drinks and effervescents, is soaring, with healthcare companies seeking to add them to their portfolios.


Having specialised in user-friendly dosage forms for more than twenty years, the new investment in its specialist manufacturing plants, is focused on powering the company’s growth while unlocking greater scale, fl exibility and cost-effi ciency for customers.


This will include new large-volume coating equipment to support growing need for advanced taste-masking; new fi lling and packaging lines for ODGs and instant drinks; expanded Good Manufacturing Practice (GMP) manufacturing and storage space; and optimised fl ow of inventory/goods on the shop fl oor.


“As pharmaceutical companies race to fi nd ways to better serve patients and differentiate themselves in a competitive market, we’re seeing unprecedented demand for more patient-centric products,” said Dr Andreas Ulrich, COO of Hermes Pharma. “Our latest investment will help us meet that demand, delivering ever greater service for our customers, while also helping us serve new customers across different market segments.


Wolfsberg premises


We look forward to getting new and improved user-friendly dosage forms to patients quickly and more effi ciently than ever before.”


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SPECTARIS Welcomes Accelerated Export Approval Measures


Since 1st September 2023, new measures to strengthen and expedite administrative processes in the fi eld of export control were introduced through the Federal Offi ce for Economic Affairs and Export Control (BAFA). The German industrial association SPECTARIS welcomed this approach but also sees further potential for improvement. “It is commendable that the urgently needed changes are fi nally coming into effect. SPECTARIS member companies have suffered signifi cantly from the long processing times at BAFA,” emphasised SPECTARIS Managing Director Jörg Mayer.


A July and August 2023 SPECTARIS member survey highlights issues and the need for action. BAFA’s average processing times for export applications in SPECTARIS sectors recently took six to


eight months, with some companies waiting over a year. This hurts competitiveness. In the survey, three-quarters noted lost orders due to delays, totalling over €150 million in pending orders.


One innovation is the accelerated approval for chosen partners. Future deliveries to specifi c EU or NATO partners are eased with general authorisations, reducing effort. However, thorough case-by- case reviews continue for other third countries. Whether this applies to ‘critical countries’ is uncertain, especially with major partners like China or Israel, where lengthy political processes persist.


Also introduced in September, further measures include extending zero decision validity to two years and expanding the goods list information’s validity.


Also, the Declaration of Export Responsibility’s validity was extended to two years.


SPECTARIS viewed the removal of the moratorium for individually attributable services critically, expected to introduce fees from 2024. This contrasts with the government’s burden moratorium, aiming to reduce bureaucratic weight for the German economy.


SPECTARIS maintains an online special page, offering updates on this issue.


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AI Adds Support to Predictive and Procedural Surgery


Cloud-based surgical software company Cydar Medical (UK), has announced the successful treatment of the fi rst patient in a strategic collaboration with Medtronic, a global leader in medical technology, services and solutions. The collaboration spans 40 sites across the United States, UK and Europe and aims to improve patient care and the effi ciency of medical professionals through application of artifi cial intelligence (AI) solutions in the clinical environment.


The fi rst patient in the pilot program was treated at Edward Hospital, in Illinois by vascular and endovascular surgeon, Dr George Pontikis, MD.


Cydar Maps, the fi rst product from the Cambridge, UK-based company’s AI technology platform, is designed to simplify complexities clinicians face when undertaking image-guided minimally invasive surgery (‘MIS’) by generating a 3D map of patient soft tissue to support and integrate pre-operative planning,


intra-operative guidance and post-operative review of endovascular MIS. This approach has been shown to offer a number of benefi ts, including halving the radiation exposure for patients and the clinical team, simplifying the clinical workfl ow and increasing clinician confi dence, which in turn can signifi cantly reduce procedure times. The pilot program is also expected to inform the platform’s on-going development, which will include predictive analytics to support optimised procedure planning based on the use of AI to compare patient anatomy and procedure outcomes from a global data set.


Dr Pontikis said: “This cutting-edge technology empowers us with the ability to navigate complex vascular procedures with greater precision- ensuring optimal outcomes for our patients. We are honoured to be a part of this innovative program and are eager to contribute to the advancement of endovascular aortic surgery.”


Paul Mussenden, Chief Executive Offi cer of Cydar Medical commented: “This is an important milestone for Cydar, to be working with Medtronic to accelerate the adoption of our AI- solution by the global endovascular community. The goal is to provide clinicians with a more predictable and effi cient way to perform minimally invasive image-guided procedures.


We look forward to supporting the treatment of additional patients across the planned 40 sites and to continue the introduction of the exciting product developments we have planned over the course of the year ahead.”


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Partnership Steps Towards Innovation for QC Labs


In a new partnership announced at SMASH 2023 (Italy, September 2023), informatics company ACD/Labs, a developer and supplier of software for R&D and MilliporeSigma, the US and Canada Life Science business of Merck KGaA, Darmstadt, Germany, announced a collaboration that will jointly progress towards innovative technology to make research and quality control in the lab more effi cient and sustainable. Science and technology company MilliporeSigma is also one of the leading manufacturers/ distributors of certifi ed reference material worldwide.


The fi rst release version of MilliporeSigma’s digital reference material (dRM) platform, ChemisTwin™, combines ACD/Labs’ automated structure verifi cation and prediction capabilities with its own expertise in high quality reference materials manufacturing to provide scientists in quality control labs with an automated structure verifi cation tool by NMR.


“With increasing demand for digital solutions in life sciences, we’re proud to provide enabling technologies for MilliporeSigma’s digital


reference material ChemisTwin™ platform,” said Andrew Anderson, Vice President of Informatics and Innovation Strategy at ACD/Labs. “Our partnership will empower scientists with a digital means for effective and robust structure verifi cation.”


“Our purpose is to shape the future of analytical testing, to make research and quality control in laboratories more effi cient and sustainable. The launch of the ChemisTwin™ platform is a breakthrough innovation in our journey toward this objective, ultimately impacting life and health with science,” said Coralie Leonard, platform project lead and Digital Business Model Developer, Analytical Chemistry at MilliporeSigma. “We have chosen to partner with ACD/Labs not only for their strong expertise in NMR spectral prediction and comparison, but also because they share our vision and passion to be a driver of industry change.”


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Andrew Anderson


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