From Science to Scale
Your Strategic Architect: Aligning Your Science, Manufacturing, and Commercial Success
Our partnership is built on a unique triad of expertise. While you pioneer the Science and Clinical Strategy, we build two parallel pillars to support you:
The Business Case: We translate every process decision into a financial and strategic reality, building a compelling narrative for investors and ensuring long-term commercial viability.
The Manufacturing Blueprint: We guide you in designing a robust, scalable manufacturing process, and then orchestrate its implementation with the best-fit partners and technologies.
Early Discovery & Feasibility
Shared Goal: To establish proof-of-concept while building the foundational business case and a forward-looking process blueprint.
Clients Focus
Science & Clinical
Executing the core science and preclinical studies to prove the therapeutic concept works.
Developing initial lab-scale processes, SOPs, and assays for internal use.
Making the go/no-go decision to proceed based on scientific and preclinical data.
Our Strategic Focus
The Business Case
Building the initial Cost of Goods (COGs) model to forecast future profitability and inform early pricing strategy.
Crafting the manufacturing and scalability narrative for your investor deck, turning process potential into a bankable asset.
Linking process decisions to your Total Addressable Market (TAM)—will the process be cost-effective enough to serve the target patient population?
Our Technical Focus
Manufacturing Enablement
Providing the "Blueprint for Robustness" guiding your lab-scale process design to ensure it's built on solid, scalable principles (QbD).
Guiding the selection of foundational technologies and raw materials, helping you choose partners and components with a clear path to GMP and commercial scale.
Advising on a data collection strategy so that every experiment you run also contributes to the long-term characterization of the process.
Early Clinical Development
Shared Goal: To establish human safety and gather preliminary efficacy data while refining the business case and preparing for scale.
Clients Focus
Science & Clinical
Owning the IND/CTA submission and all interactions with regulatory agencies.
Running Phase I/II trials and interpreting the clinical data to refine the product profile.
Managing the initial, small-scale cGMP manufacturing for early clinical supply.
Our Strategic Focus
The Business Case
Refining the COGs model with real-world data, strengthening financial projections for Series B/C funding rounds.
Developing the business case for the manufacturing strategy: Should you build your own facility or partner with a CDMO? We provide the data to make that choice.
Facilitating investor conversations, translating complex manufacturing milestones into tangible, de-risked value propositions that resonate with funders.
Our Technical Focus
Manufacturing Enablement
Work with you to Develop the Process Characterization and Validation Master Plan, a comprehensive roadmap for what needs to be proven and when.
Creating the selection framework for partners, whether it's identifying the right CDMO or vetting OEM suppliers for key automation technologies.
Providing the "Tech Transfer Readiness" package, a blueprint of all the data and documentation needed for a smooth transition in the next phase.
Late Stage & Commercialisation
Shared Goal: To achieve pivotal trial success and execute a seamless transition to a validated, commercial-ready manufacturing solution.
Clients Focus
Science & Clinical
Leading the pivotal Phase III trial and all final negotiations with regulatory agencies.
Owning the final BLA/MAA submission.
Preparing the commercial and marketing launch teams.
Our Strategic Focus
The Business Case
Finalizing the commercial COGs model to lock in pricing and reimbursement strategies.
Providing the definitive manufacturing data pack to de-risk late-stage investment and potential M&A discussions.
Ensuring alignment between manufacturing capacity, cost, and your business forecast.
Our Technical Focus
Manufacturing Enablement
Supporting the tech transfer process to your chosen CDMO or managing the project plan for your internal facility build-out.
Overseeing the process validation (PPQ) activities at the chosen site, ensuring they are executed flawlessly against the master plan.
Supporting the central author and integrator for the CMC package, compiling data from all partners into a submission-ready document.
Post Approval Lifecycle
Shared Goal: To ensure a reliable, cost-effective supply of therapy to patients and maximize the return on investment.
Clients Focus
Science & Clinical
Owning all post-market regulatory commitments and pharmacovigilance.
Managing the commercial product lifecycle and planning for next-gen therapies.
Engaging with payers and the medical community to drive adoption
Our Strategic Focus
The Business Case
Tracking key financial metrics: commercial COGs vs. plan, manufacturing ROI, and profitability.
Identifying opportunities for process improvements (e.g., yield increases, cost reductions) that enhance the long-term value of the asset.
Supporting strategic partnership or licensing discussions with a comprehensive and transparent view of the manufacturing process and its costs.
Our Technical Focus
Manufacturing Enablement
Providing expert oversight of the selected CDMO or internal manufacturing team, acting as your technical representative.
Managing the network of technology and supply chain partners to ensure continuous, reliable supply and mitigate any disruptions.
Guiding long-term process monitoring and lifecycle management, ensuring the process remains in a validated state of control.