# Proposal Draft: PeptideWorks Inc — Peptide GMP Manufacturing ## Scope of Work This proposal outlines the scope of services for PeptideWorks Inc for the GMP manufacturing and development support of a peptide compound currently in Preclinical stage. **Target Scale:** 500 grams **Manufacturing Standard:** GMP **Program Stage:** Preclinical ## Deliverables 1. **API synthesis** GMP synthesis of peptide API at 500 grams scale. Includes process optimization, in-process controls, and batch record documentation. 2. **Analytical method development** Development and validation of analytical methods for identity, purity, potency, and related substances testing. 3. **Stability studies** ICH-compliant stability studies under accelerated and long-term conditions. Includes protocol development, sample pull schedule, and stability reports. ## Proposed Timeline **Client Target:** IND filing by end of next year | Phase | Activity | Duration (est.) | |-------|----------|----------------| | 1 | Project Kickoff & Technology Transfer | 2-3 weeks | | 2 | Analytical Method Development & Validation | 6-8 weeks | | 3 | GMP API Manufacturing Campaign | 4-8 weeks | | 4 | Stability Studies (initiation + ongoing) | Ongoing (6-12 months) | | 5 | Final Reports & Project Closure | 2-3 weeks | *Note: Timeline estimates are preliminary and subject to project kickoff discussions and resource availability.* ## Exclusions - Commercial-scale manufacturing - Sterile fill-finish operations (unless specifically scoped) - Regulatory filing preparation (unless specifically requested) - Clinical trial management and logistics ## Risks & Dependencies - Timeline dependent on timely receipt of starting materials and reference standards from the client - Analytical method transfer timeline assumes methods are partially developed - GMP documentation package timeline may extend if significant process modifications are required - Regulatory audit readiness assumes no major findings from pre-project facility assessment - Scale near facility capacity limits; detailed capacity assessment required before commitment - Any changes to scope after project initiation may impact timeline and cost ## Assumptions - Client will provide compound characterization data, synthetic route, and any existing analytical methods within 2 weeks of project kickoff - Starting materials and reference standards will be supplied by the client or sourced by mutual agreement - Quality Agreement to be executed prior to GMP manufacturing activities - Client responsible for regulatory strategy and filing - Project changes require formal change control process ## Next Steps 1. Client confirmation of scope and deliverables 2. Project kickoff meeting to finalize technical details 3. Execution of Master Service Agreement and Quality Agreement 4. Detailed project plan and cost estimate to follow after kickoff --- *This is a preliminary proposal draft generated by the CDMO BD Triage System. Final pricing and detailed project plans will be provided after technical review and project kickoff discussions.*