Review & select antigens, excipients, devices

Select process and establish/characterize with client

Benchmark product and prepare target product profiling (TPP)

Review and select container/closure systems

Select drug substance/product storage conditions

Specify dose size, dosage form, and delivery method

Review and select placebo & diluents

Prepare pre-clinical and non-clinical strategy

Advise on animal welfare, 3R

Review and select animal model(s) for safety, immunogenicity and efficacy

Develop potency assay, correlates of protection

Review and select surrogate potency and safety (cell-based) methods

Design and advise on safety and toxicology studies

Draft specifications for Drug Substance/Product (DS/DP)

Draft specifications for storage container & mode of delivery

Specify in-Process Control (IPC) and QC release tests

Draft stability plan and shelf-life proposal (DS/DP)

Review qualification and validation of QC release tests

Provide project, programme, and portfolio management

Establish project management office, PMO

Provide capacity in leadership and management

Plan and manage product life cycle

Prepare/review product development plan and associated Gantt chart

Implement/review existing project management tools and practices

Investment and funding support, including due diligence

Select host cell line and define cell banking

Develop upstream and downstream process

Develop analytical methods

Propose and advise on vaccine adjuvants and formulation

Select excipients and adjuvant process

Optimise product storage conditions

Review and audit CDMO

Select CDMO and support MSA & Quality agreements

Manage CDMO-client relationship

Prepare a clinical development plan

Propose or identify site, CROs, laboratory, and study countries

Prepare or contribute to protocol and related documents

Propose or advise on a regulatory strategy

Prepare or contribute to the CMC/IMPD

Prepare or contribute to the CTA/IND/IB