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Almac Group – Partnering to Advance Human Health White Papers

Almac Group – Partnering to Advance Human Health

A Survival Guide to Temperature Data in Life Sciences, by Almac Regulations continue to evolve globally within the distribution arena of the Life Sciences industry. Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01)1 as well as Good Distribution Practices Supply Chain Integrity2 has made the most significant impact. There is an increased focus on companies being able to prove the quality and integrity of their drug product throughout the entire supply chain. The industry is facing stricter compliance demands from regulations and regulatory agencies are not always given clear guidance.
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Almac: Changing the Dynamics of Temperature Controlled Shipping Solutions In the typical clinical trial today, the cost of shipping and distributing supplies accounts for approximately 60 percent of the overall clinical supply chain. And when the cost of product spoilage from temperature excursions is added into the mix, it is no wonder that pharmaceutical companies, Clinical Research Organizations (CROs), and logistics vendors are all eagerly searching for efficiencies and ways to carve costs out of the process.
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Almac Explores Interactive Response Technology: An Untapped Source of Historical and Real-Time Data for Risk-Based Monitoring Risk-based monitoring has attracted the support of a diverse group of organisations in recent years. Regulators have released guidance encouraging the use of risk-based approaches to clinical trial quality, vendors have created technologies to support such methods, and large pharma companies have pooled their resources to drive adoption. Yet, despite this flurry of activity, the industry has overlooked a potentially useful source of real-time and historical data.
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Almac Presents Modern Perspectives on Peptide Synthesis, an Introduction The complexity of synthetic peptide products, whether as reagents used in research or as therapeutic APIs, is increasing. As researchers understand more about the biochemical systems which are targeted, and invent ever more sophisticated products, manufacturing methods must keep pace. We look in this article at a number of challenging product classes, the specific problems they present, and potential solutions: Long peptides; Multi-peptide cocktails; Site-specifically modified products.
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Almac: Crystallisation of Pharmaceutical Compounds The Almac Group explores the chemist's role in protecting intellectual property. It provides development and manufacturing services for Active Pharmaceutical Ingredients (APIs) to pharmaceutical industries worldwide. Over the past 40 years, we have made numerous discoveries that have become powerful intellectual properties (IPs) for our customers.
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Sciences Radiolabelling Brochure Trust Almac with your 14C radiolabelling requirements and we will offer advice on the most appropriate label position for your molecule, including synthetic feasibility and metabolic stability.
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Commerical Packaging - Complementary US and UK operations, - Quality-driven, flexible packaging solutions, - Market leader for product launch of niche / orphan drug products, - Solid oral dose and biopharmaceutical packaging, - Packaging and artwork design, - Full serialisation and 2D matrix barcoding solutions.
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Providing an Unparalleled Range of Contract Pharmaceutical Development and Manufacturing Services Globally for Over 40 Years Only we can combine the expertise from our range of specialised services to provide you with the right solutions to help you develop and commercialise your products.
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Building the Next Generation IRT: An Exclusive Look Under the Hood of IXRS®3 Interactive Response Technology (IRT) systems - used to manage patient interactions and drug supplies during clinical trials - perform a range of functions for sponsors, drug depots, and investigative sites. Yet, they are typically viewed by sponsors as a "painful necessity" rather than as a welcome, invaluable tool. That perception exists because the underlying technology is outmoded, and the user's experience is stuck in the pre-Internet era. While established systems are "tried and true" in that they have supported thousands of clinical trials over the years, they can also be tired and cumbersome.
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Introducing Direct to Patient Shipments Almac will ship the Clinical Trial Material (CTM) to participating clinical sites, where the drug is to be stored. Both shipping and storage of the CTM will follow standard procedures. Sites will interact with the Interactive Response Technology (IRT) provider in the usual way to obtain a kit assignment.
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