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Transparency in Chemical Sourcing for Pharmaceutical Development
We regularly hear from our customers in the drug development industry that supply chain consistency & transparency is a key requirement when sourcing chemicals, here we explore this in more depth.
Chemicals are materials that are used for a range of applications across numerous industries. In the pharmaceutical development industry, the chemicals used include basic fine chemicals, solvents, advanced intermediates, catalysts, excipients and complex materials such as proteins. They are required to perform a specific function to a high standard, and failure to perform to a consistent standard can have serious consequences for the product or process they are being used in.
Identifying the Chemical Supplier
To ensure product consistency, reduce the chance of problems downstream and to ensure smooth delivery of sourced chemicals, supply chain transparency is key, and this starts with knowing who the manufacturer is.
In most cases, the supply chain for a specific chemical is made up of a certain number of manufacturers who make the product, and a lot more trading companies marketing and selling the product. If you are not working directly with a manufacturer, the ‘middlemen’ companies will be reluctant to divulge the name of the true manufacturer for fear of being cut out of the supply chain. However, for customers who have regulatory obligations to meet, e.g. a CDMO undertaking phase 2 or 3 drug substance trials, knowing the name of the manufacturer is regulatory requirement.
Even if you are knowingly working with a trading company or a chemical sourcing company, it is still important to know the name of the manufacturer to ensure that each time a purchase of the material is made, it is being manufactured by the same factory using the same process.
Understanding the Chemical Manufacturing Route
Two manufacturers making the same chemical might employ different manufacturing routes, resulting in the same product but with differing purity profiles. Although the chemical is the same, the different manufacturing methods employed might have implications for the downstream process that this material is used in.
A trading company who does not divulge the name of the manufacturer might feel no obligation to use the same manufacturer to fulfill an order for a specific chemical, even if it is a repeat from the same company, and may switch the manufacturing source depending on business pressures such as product availability or changes in price from different factories.
Another aspect of transparency is knowing the manufacturing route of a specific material.
For our customers who are using the intermediates we source for them to develop API’s, it is necessary for them to know the manufacturing route of an intermediate. Knowing the manufacturing route allows them to understand what impurities might be present in the material they are purchasing, and if any of these process impurities might carry through into the API or go onto react during later manufacturing steps to form other impurities. Likewise, it is necessary to know which solvents or catalysts have been used in the synthesis of an intermediate in case there are residual traces of these materials in the intermediate which might be carried through to an API.
It is also important for our customers to know the analytical techniques & methods used by a manufacturer to analyse a specific chemical. Different methods of analysis can lead to different reported results and if the customer and manufacturer are using different analytical methods, this can lead to inconsistencies between results obtained by the manufacturer and the customer.
This can be the difference between a material meeting the required product specification or being out of specification and is especially important if there is a strict requirement on the content specification, or on the content of a specific impurity. In this case, knowing what method is used and making sure there is consistency in the methods used by manufacturer, customer and QC analysis is essential.
Working With FB Pharmtech
FB Pharmtech is a chemical sourcing company; we work with a network of manufacturers and suppliers to help solve our customers’ chemical sourcing challenges. We understand the importance to our customers of being transparent about where the materials are being made, how they are being made and how they are tested, especially for materials being used in drug development, and we will do our best to support them however we can.
Get in touch to speak to us about pharmaceutical chemical sourcing.