A US biopharmaceutical company approached Almac to assist with the EU product launch of their high value, orphan drug product. As the drug product was temperature sensitive with minimal allowable temperature excursions a key deliverable of the project was to design and qualify a temperature controlled shipping solution to ensure delivery of the production optimum condition. Throughout this case study Almac will highlight the challenges that arose and will provide solutions on how these challenges were overcome to facilitate a successful product launch.
Use technology to achieve desired product performance.
A small sized pharmaceutical company was approaching the final phases of a large phase III global multiple treatment arm oncology study that involved comparator drug. The study criteria required the client to provide study medication to patients active at the conclusion of the study until the drug would be commercially available, when it could then be prescribed to patients continuing treatment.
A case study of hydrogen peroxide penetration through the load packaging. Customer support for «Package Integrity Verification» which involved all the samples and consumables inside the Sterility Test Isolator.
Developing medicines is a timeintensive and costly process with a high risk of failure — especially in the early phases. The entire drug development process is subject to the guidelines of Good Clinical Practice (GCP), the international standard that governs planning, implementation, documentation and reporting in clinical trials involving humans.
A demonstration of how using MVA and DoE to span the variation in a data table with a subset of the samples and plan designed experiments to get the most learning with the least number of experiments.
The significant interest in semi-solid systems for the potential of extended release profiles has prompted researchers to develop alternative encapsulating systems. It is challenging to find optimal development solutions to enhance bioavailability for drug compounds contained within complex fill formulations . Catalent Pharma Solutions has lead research studies to establish technology can accommodate a wider range of excipients and more molecules.
An innovative biotechnology company exploring novel therapeutics for neuroscience indications had developed a promising new chemical entity for the treatment of a severe pediatric genetic disease. However, numerous drug delivery challenges threatened the realization of the Fast Track status designation they had received due to promising early stage results. By leveraging a softgel technology, the customer was able to overcome a number of potential hurdles and expeditiously enter the Phase II/III clinical trial.
Xhale, Inc., a commercial stage medical technology company, had developed the SMART® Medication Adherence Monitoring System technology to non-invasively monitor adherence to oral medications. Efficient encapsulation of 2-butanol has to overcome many challenges, which requires optimization of not only chemical composition, but also manufacturing parameters such as lower processing temperature and thinner softgel shell.
Synthetic oligosaccharides are used in clinical practice as anticoagulants. Due to their poor oral bioavailability, oligosaccharides — along with most pharmaceutical macromolecules — are formulated as solutions or suspensions and delivered by invasive intravenous (IV) or subcutaneous injection. When oral bioavailability is increased, macromolecule can potentially be converted from injectable to oral drug delivery. This case study demonstrates how OptiGel ™ Bio technology significantly increases oral bioavailability of a synthetic oligosaccharide, thus enabling oral conversion.
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