Woodley BioReg was involved in drafting the regulations for Well-Characterised (now Well-Specified) Biologics and Comparability Protocols which have now been in effect for over three decades.
Our EU client requested our support following a rejection of their proposed submission for a change in the site of manufacture, from one location in the EU to another — as well as some changes in the manufacturing process for their approved vaccine.
Our team undertook a detailed impact assessment of the client’s proposed changes on product quality, safety and efficacy, and using the established frameworks within well-specified biologics and comparability legislation, we designed a comprehensive biochemical bridge to demonstrate product equivalence pre and post the proposed change.
This is an approach that Woodley BioReg developed and refined following similar projects we had previously been involved with.
This was presented to regulators both in the EU and the US, and while there were some questions posed by the regulators, the approach taken by Woodley BioReg was within compliance with the legislation and ultimately approved.
The client was able to commercialise their product without bridging clinical studies, and saved around $14 million in study costs and over 12 months in time.
Woodley BioReg has continued to develop and refine its approach to using Comparability Protocols, including to support accelerated vaccines and product development during the Covid-19 pandemic.
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