After successfully outsourcing an initial CMC project to Almac and being extremely satisfied with the level of service with regards to technical ability, communication and project management, the following year, the global big pharma company sought a more strategic CMC outsourcing partnership and established Almac as a preferred provider, placing 10 projects within 12 months.
Treating castration resistant prostate cancer means that failure within the advanced therapy supply chain has a catastrophic impact on patients. This case study describes the use of dispersed storage and cold chain logistics, around a central manufacturing facility to create a cost efficient and robust supply chain.
Mixing powders into liquids efficiently is crucial to productivity in pharmaceutical and biopharmaceutical manufacturing. In some operations, high shear is beneficial, and the resulting heat causes no problems. However, for operations where low shear and high product integrity are required, traditional technologies pose a risk to the quality of the final product. Here we review the technology, operation and testing protocols, and present the results that demonstrate the venturi system’s efficacy for low-shear, low-heat applications.
While media and buffer materials have been notorious contributors to airborne particulates and contamination in the past, they don’t have to be. With careful evaluation and system specification, new, dedicated powder transfer systems can help eliminate those issues in closed processes.
See how one simple change can drastically reduce the time it takes to get biologics manufactured. Getting media and buffer into large-scale, continuous bioprocessing has been burdensome, time consuming and messy. Upgrading to modern single-use powder handling in your process gets your product to market without time wasted on complicated weigh and dispense steps, cleaning validations, or worries about powder in the air and in the room.
The SIMULIA Living Heart Human Model provides a unique testing environment where a pacemaker lead can be virtually inserted and mechanically deformed during the cardiac cycle. Once the mechanical deformation results are obtained, the long-term durability of the implant can be assessed. The virtual nature of the test provides a physiologically accurate methodology to test new and existing devices without exposing patients to un-necessary risk.
The SIMULIA Living Heart Human Model provides a unique testing environment where a stent can be deployed virtually in coronary arteries and deformed mechanically during the cardiac cycle. Once the mechanical deformation results are obtained, the long-term durability of the stent can be assessed. The virtual nature of the test provides a physiologically accurate methodology to test new and existing devices without exposing patients to unnecessary risk.
Admedes, a leading stent manufacturer, was looking for ways to extend the lifespan of their implantable Nitinol stents, heart valve frames, and similar cardiovascular repair components. Simulating the implantation of devices within Dassault Systèmes’ Living Heart model, engineers used Abaqus FEA to identify stress areas and potential failure points of Nitinol structures, then optimized the topology of the components using Tosca Structure.
In response to a patient’s unique problems with a failure of a previous stent implant, researchers at University College London Institute of Cardiovascular Science used Dassault Systemes’ SIMULIA Abaqus, in combination with patient image data, to create personalized, virtual models of the patient’s anatomy. The implantation of different sized stents was simulated to compare their effects on blood flow, pressure, and aneurysm coverage.
Dassault Systemes has brought together a multidisciplinary team of experts to collaborate on breakthrough technology with the Living Heart Project for improved products and treatments for cardiovascular disease. The project’s first output is the Living Heart Model (LHM), a realistic 3D computational model of the human heart. This case study discusses the Living Heart Project and the plans for further developments and clinical applications rising from its efforts.
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