Vaccine Site Selection Case Study

The Brief:

Lafferty were engaged to provide consultancy services assisting a client With the identification and selection Of a suitable brownfield site for a potential large scale bulk drug substance (vaccine) manufacturing facility in Europe.
The client was seeking an enabled brownfield biopharmaceutical site in western Europe to manufacture their seasonal flu vaccine. Start to finish the client required the site to achieve regulatory approval and be ramped to 60% capacity in 5 years.
The client provided a list of preferred locations consisting of several countries within Europe for assessment. Lafferty’s scope was to perform a desk top assessment to identify if a suitable site within the preferred countries was available to meet the client’s stated technical requirements and timeline.

The Approach:

■ Lafferty proposed a suitable time period to conduct the desktop assessment. Assuming full engagement from the relevant state bodies and the client.
■ Key contacts within each state agency were quickly identified to support the desktop study.

■ We developed and proposed a scoring criterion for ranking any proposed sites.
■ Lafferty issued the briefing document to the various state agencies and held a kick-off meeting to ensure total clarity and understanding on the requirements.
■ Regular meetings and communication tracking progress with the client were managed by Lafferty.
■ Lafferty held ad hoc meetings with the state agencies as required to help progress their responses.
■ All responses from the various state agencies were consolidated, summarized, and associated risks and opportunities for each response were identified.
■ During the course of the assessment Lafferty progressed the ranking Of options according to the criteria agreed up front and provided interim updates to the client.
■ A draft of the final report was reviewed and agreed with the key client contact in advance Of further distribution within the client organisation.
■ Lafferty issued a final report to the client with a clear executive summary of the findings.

Drug Product

Feasibility Study Case Study

The Outcome:

The following outcomes were realised for the client:
■ The final report enabled the client in making appropriate strategic decisions with regards to pursuing brownfield or greenfield options and potential geographic locations for their proposed project.
■ A concise report, including an executive summary of potential options was presented to the client for consideration within the time frame agreed.
■ The due diligence in terms of identifying potential brownfield site locations for the client’s project was executed in the timely and efficient manner, without an unnecessary draw on client resources.
■ The client’s confidentiality was maintained at all times. Despite state agency desire to interact directly with the client Lafferty maintained the client’s anonymity while completing the assignment thereby reducing unwanted communications and distractions being directed to the client.
■ By engaging a third party to support this activity the client ensured consistency of approach/response and eliminated any potential for biased assessment Of potential locations for the project.