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MedTech
EsoCap: Improving the lives of 370 million people with oesophageal diseases
The oesophagus is a particularly challenging environment for drug delivery. Zühlke supported EsoCap in jointly developing an automated prototype production line for EsoCap's novel drug delivery system.
The benefits at a glance
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The solution is now ready to be scaled up to automated production, opening up new market opportunities for EsoCap.
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Detailed analysis of potential process risks and most critical issues.
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Tested, proven, working prototype of the production line as an important milestone basis for further development and scaling.
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The working prototype of the production line and detailed specifications provide an excellent basis for negotiations with potential manufacturers.
Oesophageal diseases such as eosinophilic oesophagitis (EoEEoO), gastroesophageal reflux disease (GERD), Barrett's syndrome and oesophageal cancer affect approximately 370 million people worldwide. Today, topical treatment fails due to the short residence time of ingested drugs in the oesophagus.
EsoCap's vision is to improve the lives of these patients through targeted, long-lasting, topical therapies for the upper gastrointestinal tract. Zühlke helped EsoCap build a scalable prototype production line in preparation for commercial production.
Initial situation & challenge
Ingested medications remain in the oesophagus, in the area between the mouth and stomach, for only a few seconds. Physicians, healthcare providers and patients are looking for effective and safe treatments, and there is still a need for oesophageal-specific drug deposition.
EsoCap has developed a revolutionary smart drug delivery technology to address this challenge. EsoCap's innovative delivery technology consists of a drug-loaded thin film rolled up in a capsule that unrolls and adheres to the oesophageal mucosa when swallowed. This ensures local drug delivery and prolonged mucosal contact as the film slowly dissolves and delivers the drug locally.
An initial study in healthy volunteers successfully demonstrated the functionality that this promising, innovative solution is both safe and effective. However, EsoCap faces the challenge of scaling production from laboratory to automated production scale.
EsoCap therefore turned to Zühlke for assistance in scaling up production and evaluating commercial feasibility.
“We are pleased to be working with Zühlke on process development for automated production of EsoCap technology.”
From initial manual to automated production
The collaboration between EsoCap and Zühlke targets the entire process of transforming initial manual production into an automated production line that serves as a blueprint for high volumes. State-of-the-art technologies such as virtual reality (VR) or 3D printing will be used to achieve the goal as efficiently as possible. Along the way, the team of highly skilled engineers will constantly reduce identified risks and define requirements for the automated assembly of millions of EsoCaps per year.
"A major challenge in commercializing our multicomponent formulation is the ability to produce cost-effectively on an industrial scale while maintaining strict sterility and quality standards. With our innovative application design and Zühlke's expertise in process automation, we are well positioned to meet this challenge", said Dr. Peter Stangier, Director Strategic Planning at EsoCap.
The result of this collaboration is a prototype production line that will demonstrate the feasibility of large-scale production.
EsoCap and Zühlke have begun evaluating potential contract manufacturers who will be able to transfer this prototype to a GMP production environment.
Benefits
With the prototype of an automated production line designed and built by Zühlke, EsoCap can demonstrate that its solution works up to commercial scale, and define the conditions necessary to do so. The prototype allows EsoCap to test and link the different production steps and can be used as a reference model for negotiations with manufacturers.
Thanks to Zühlke, EsoCap is a big step closer to its goal of supporting the 370 million patients with oesophageal diseases worldwide with its innovative solution.
