SUPPLY CHAIN MANAGEMENT
The criticality of critical raw materials
Chris Neasham , global procurement manager at Almac Sciences , and Professor Thomas S . Moody , VP of technology development & commercialisation at Almac Sciences and Arran Chemical , discuss how raw material procurement should work in the pharma industry
To provide critical raw materials ( CRMs ) for chemical manufacturing in pharmaceutical applications , it is necessary to use an adaptable procurement strategy that works for the business from development right through to commercial manufacture . Depending on the manufacturing facility , the scope and the clinical phase of the project , CRM requirements can range from a few grams of a novel , custom-made compound right through to multitonnes of advanced building blocks or intermediates .
Supply chain departments need to ensure an appropriate raw material delivery strategy is in place , thereby providing the correct materials at the right location within acceptable timelines so that final products can be delivered for a diverse client base . This article outlines some of the key challenges pharmaceutical and fine chemical manufacturing procurement teams face when purchasing CRMs , while providing some insight on how to deal with arising issues by development and implementation of robust risk mitigation strategies . Figure 1 summarises key points to consider for CRM manufacture .
Beginning : Firsttime , small-scale
First-time scale-up to support toxicology or Phase I trials is often when supply chains are first implemented . In many cases , the
Figure 1 – Almac ’ s summary of CRM manufacture criteria
routes of synthesis are not developed beyond the medicinal chemistry route and initial work involves accessing a route of synthesis that is scalable . Timelines are critical and supply chains needs to be adaptable as the routes are being developed .
The challenges faced with these projects are usually two-fold . Firstly , sourcing small amounts of a compound that has never been made at scale ( hundreds of grams through to low kilos ) can be a challenge , so selecting the right outsourcing partner or manufacturer is key . To have a high level of success , supply chain knowledge and an understanding of what potential partners can deliver is critical . Rapid identification of providers who specialise in specific types of chemistry is essential .
Many manufacturers claim they are the right partner for the scale-up of multiple specialist chemistries , but in many circumstances , this is not the case . In fact , experience dictates that manufacturers who claim to do everything are not necessary the correct partner for a selected specialist project . An in-depth knowledge of capability is critical for
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