CONTRACT & TOLL MANUFACTURING
Concerns over the protection of IP rights have long impacted the selection of a location for the final stages of drug substance manufacture . The combination of a lack of transparency and questionable quality practices among some manufacturers has more recently led to a desire ( need , even ) among many pharmaceutical companies to onshore the manufacture of process intermediates and RSMs as well .
Supply chain matters
When combined with the significant geopolitical and economic implications brought on by COVID and the associated supply chain challenges , the risks of manufacturing any part of the drug substance supply chain outside the US or Europe often now outweigh the benefits . While production at qualified facilities in North America or Europe is the preferred choice for critical intermediates , using near-shore toll manufacturing can mitigate the economic impact of
Manufacturing at Actylis ’ plant in Limerick , Ireland reducing reliance on distant locations while simultaneously addressing accompanying regulatory concerns and lack of transparency .
Complementary to this , the added toll manufacturing strategy implemented by companies like Actylis provides clients with technical and regulatory oversight of the manufacturing processes while still providing an economic advantage when compared to manufacture in the West . For this to be a viable option , expertise on local regulation is an absolute necessity . In addition , back-integration of processes can be undertaken .
Under this paradigm , process R & D is conducted in facilities in the US or the UK with full transparency to clients . Through partnerships with a variety of Indian manufacturers , the developed processes are transferred to partner companies and materials are manufactured in India with direct oversight by process development scientists .
The partner companies are preaudited by Actylis and are selected based both on their technical capabilities and on their adherence to rigorous quality standards . As a result , clients can be assured that production of their critical process intermediates and RSMs is executed with full transparency in facilities wellprepared for audit by the necessary regulatory authorities .
This toll manufacturing model is an economical and practical solution to regulatory concerns encountered in the manufacture of key process intermediates and RSMs . For clients who still prefer manufacture of key stages to be executed in the US or Europe , though , this model can be further customised through a hybrid approach .
By careful evaluation and through consultation with quality and regulatory experts , the synthesis of key process intermediates and RSMs can often be reduced to one or two critical processing stages to be effected under the highest quality standards with maximum transparency and close to the end users . To this end , technical experts consult with clients to identify the most efficient combination of toll manufacturing and manufacture within the European or North American facilities of companies like Actylis . ●
Paul Staunton
GLOBAL COMMUNICATIONS MANAGER
ACTYLIS k + 353 87 922 5000 J pstaunton @ actylis . com j www . actylis . com
26 ESTABLISHED 1981