Request for Proposals - Expert(s) in end-to-end vaccine manufacturing to perform on-site assessments

REQUEST FOR PROPOSALS

Expert(s) in end-to-end vaccine manufacturing to perform on-site assessments

The Medicines Patent Pool (MPP) is seeking for proposals from individuals/organisations expert in end-to-end vaccine manufacturing with experience in development, technology transfer and GMP production to perform on-site assessments at the facilities of the manufacturing partners participating in the mRNA Technology Transfer Programme.

A proven track record in the mentioned fields is therefore preferred.

Interested individuals/organisations should submit the following information: (1) understanding of the scope of the assistance requested; (2) CV including a description of relevant activities and experience; (3) fees to perform the site assessment visits and reporting; (4) additional fees or expenses.

The deadline for submission of proposals is 08^th May 2023.

Background

The mRNA Technology Transfer Programme is a global initiative led by the World Health organisation (WHO) and the Medicines Patent Pool (MPP) that aims to improve health and health security by establishing sustainable, locally owned mRNA-based vaccine manufacturing capabilities in and for low- and middle-income countries (LMICs). To achieve this goal, the Programme is funding the development of an mRNA-based vaccine manufacturing technology platform at Afrigen Biologics (South Africa) with the objective to transfer it to 15 Programme Partner organisations selected by WHO and located in different LMICs.

Objectives

Perform physical assessments (field visits) of the mRNA Technology Transfer Programme network partners facilities by using an assessment form to be agreed upon with MPP.  The assessment (lasting an average of 3-4 days/visit) will cover end-to-end vaccine manufacturing capability, capacity and track record with regards to product development, technology transfer, and GMP production. The assessment will comprise of the following areas:

• R&D facility capability and capacity, including development and technology transfer experience, as well as pre-clinical and clinical capability and track record;
• GMP production (drug substance and drug product) capability and capacity;
• Facilities (R&D, Production, QC) readiness status and GMP accreditations;
• Technical requirements to establish a mRNA technology platform, including process and analytics, equipment and raw materials;
• Quality Assurance and Regulatory experience and interaction with local and/or international Regulatory Authorities;
• Human Resources plans, gaps, training and experience in key technical activities for the implementation of mRNA technology;
• Supporting departments: Business Development, Health and Safety, Project Management, Supply Chain, Stability, etc.

As outlined below, the scope of the present request includes the assessment of facilities of at least 10 network partners.

Deliverables

Completed assessment form (questionnaire) and a concise report to be submitted to MPP for each Partner facility visited detailing the gaps and needs for the Partner to address in order to be able to absorb the mRNA technology platform at a R&D and commercial manufacturing scale. Timelines for assessment and report submission to be defined in agreement with MPP (ideally to be provided directly after each visit).

Places of Perfomance

* timelines to be determined 

Requirements

• Proven experience in the key areas identified by MPP for the assessment of the mRNA technology transfer Programme partners and listed under Scope of Work.
• Ability and availability to travel to all countries where Programme Partners are located.
• Flexibility to start visits in line with MPP’s timelines and to be completed within the required timeline.

NOTE: MPP would welcome the possibility to evaluate any already existing assessment template to be adapted to the specific scope and to be complemented with MPP template

Contract Period: Jun 2023 – Dec 2023 

Number of field visits: 10 (possible expansion to a maximum of 15), 3-4 days each [ideally, visits should be grouped regionally based on a priority list provided by MPP]. MPP staff (TBD) will join to support during the visits. 

Number of consulting days: up to 80 days