SUPPLY CHAIN MANAGEMENT
Figure 2 - Almac ’ s strategy for controlling supply chain for CRMs
supply chain purchasers to select the correct partner .
It is , however , refreshing to receive a ‘ no bid ’ from a manufacturer , as this builds trust and creates the understanding that they are only prepared to offer on opportunities they can deliver on . The likelihood of a provider being considered for another future opportunity that aligns with their technical chemistry competencies is much more straightforward after a ‘ no bid ’ quotation rather than after a failed synthesis on a compound that they should not have been considered for in the first place .
Building a supply network to outsource projects appropriately to the correct third parties who have demonstrated they can deliver high rates of success is a critical factor . The Almac Group has invested significant time in developing these solid relationships through a range of key success factors . We assess a manufacturers ’ technology offering , appraising their ability to meet our chemical needs . They are assessed by both quality and technical audits to ensure they are robust enough for our long-term needs .
Environmental and corporate social responsibility criteria are also determined to ensure alignment with the group ’ s overarching strategies . It is also essential to visit manufacturing sites and foster relationships with key brokers and trusted third party manufacturers to further ensure they can deliver against specific and challenging requirements .
The other major challenge typically encountered during these earlystage development programmes is milestone management and schedule adherence . Clients expect to see provisional results from early lab studies as soon as possible , and the rate-limiting step can be access to the projects ’ more complex CRM .
The obstacle is that , in many cases , the CRM is not available from stock and requires synthesis before project initiation . In this scenario , and by reviewing the synthetic complexity of the material required , we recommend and often initiate a simple risk mitigation strategy allowing us to dualor even multi-source , dependant on the client ’ s appetite for risk .
Supply at this scale for process familiarisation activities is often only hundreds of grams , so there is a manageable cost impact on the project which should be included in the original proposal and is completely visible to the customer .
Being able to manage two or more different manufacturing partners with the goal that at least one of them will deliver within the required timelines is the objective . Often both will deliver , meaning the chemistry team can ‘ use test ’ both material sources in the process .
This delivers rich information by generating data on the downstream chemistry and subsequent impurity profiles . We can then make an informed decision on the scaleup partner who can then become a source for future , larger-volume material orders .
Once the initial orders for manufacturing have been agreed , we establish regular technical updates regarding manufacturing progress . This critical step highlights any potential technical issues or timeline delays and allows us to troubleshoot with the partner . This allows timely communication to the project team and adjustments to the supply strategy if there are delivery concerns , while keeping the client appraised .
Starting somewhere else
Generally , the best practice in procuring CRMs is to do so when the route of synthesis and the supply chain are fixed and the manufacturing sources established from an early phase . Ideally the supply chain will select a source who is able to scale up the output volume of materials and who will be ‘ qualifiable ’ from a regulatory perspective as the programme develops through the clinical phases .
However , when projects are inherited at a later stage , vendor due diligence may not have been performed and the raw material manufacture and supply may reside at less desirable sources . Fundamentally , by reverting to the procurement principles above , material supplies should be able to be redirected to robust sources within the strong network established . Changing the manufacturing source can inadvertently create problems in the development labs for the technical team ( s ). New supply sources may mean new routes of synthesis , different solvents and / or reagents being deployed in the process , creating issues in later chemical steps , such as yields and , importantly , impurity profiles in the
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