CMC & TechOps, scoped to your stage and capital position.

CMC Strategy & Roadmapping

A phase-appropriate CMC plan that ties process, analytics, supply, and documentation to your clinical milestones, capital plan, and target product profile. We map what must be locked now, what can be deferred, and where to invest first dollar so your CMC story scales with your clinical story.

Most early teams are over-investing in some areas and dangerously under-investing in others. The roadmap surfaces both — and gives you a defensible answer the next time your board, partners, or potential acquirers ask "where's CMC?"

CDMO Selection & Oversight

The CDMO market for viral vectors is opaque, asymmetric, and changing fast. We design the RFP, run the technical diligence, structure the contract from the sponsor's perspective, and stay engaged for ongoing oversight — joint steering, deviation review, batch disposition support, and the hard conversations.

The goal is straightforward: make sure the CDMO is delivering what your program actually needs, on a timeline you can defend, with a paper trail you'll be proud of at IND.

Process Development & Tech Transfer

Upstream and downstream PD strategy for AAV (natural and engineered capsids), lentivirus, and adjacent viral vector platforms. We help you decide between transient transfection and stable producer cell line routes, choose the right capture and polish chemistry, and design comparability up front so process changes don't blow up your filing.

Tech transfer is where most programs leak time. We design the package — and the joint working sessions — so the bench-to-GMP handoff actually survives contact with reality.

IND-Ready Technical Documentation

Module 3 authoring and review. Phase-appropriate control strategy. Comparability protocols, stability programs, and the dozens of supporting technical reports that quietly determine whether your filing lands cleanly or comes back with a clinical hold question.

We write to be defensible, not decorative — and we structure the package so future amendments and post-IND changes don't force you to redo it.

Documentation Backlog Cleanup

Most lean teams accumulate a documentation backlog while they're focused on running the program. Hand us the batch records, MSRs, and development data from your CDMO or your internal team — anything that didn't get drafted into a report along the way — and we turn it into the process characterization, process history, process development, and process trending reports you need. Structured for both internal decision-making and direct inclusion in the IND.

Ex-US First-in-Human Pathway Strategy

Going overseas for first-in-human can save real time — or create a CMC package that won't bridge cleanly back to a US IND. We help you separate those two outcomes before you commit.

This includes IIT planning and design, IIT-to-IND bridging strategy, ex-US partner and CDMO selection, and the comparability and documentation work required to bring data and material back to a US program without re-running the clock.

Engineered Capsid CMC Readiness

AI-designed and rationally engineered AAV capsids unlock biology that natural serotypes can't reach — and they challenge platform assumptions across process, purification, analytics, and comparability. Manufacturability decisions made at the discovery bench have outsize downstream consequences.

We help discovery and CMC teams collaborate earlier: scoring candidate capsids on manufacturability, anticipating analytical gaps (full/empty, identity, potency), and building a CMC story that holds together from first transfection through Phase 3.

The Other Side of the Table: Advisory for VCs, CDMOs & Technology Companies

Sponsor-side judgment, applied from the other side of the table. ViroSpark advises VCs evaluating gene therapy investments, CDMOs and technology companies positioning for early-stage biotech buyers, and platform companies navigating in-licensing decisions — bringing the same operator experience and the same network, just sitting in a different seat.

Due Diligence for VCs & Licensing Teams

Technical CMC diligence for venture investors, family offices, and corporate development teams evaluating gene therapy and viral vector opportunities. An honest read on capsid manufacturability, process maturity, CDMO posture, regulatory risk, and the gap between the pitch deck and the lab notebook. As a CGT subject-matter expert who has worked both sides — out-licensing and in-licensing — and who has founded a biotech, I know what credible CMC stories look like and how to spot the technical risks that quietly sink deals.

CMC Strategy Consulting & Market Intelligence

Strategy memos, modality-choice analyses, market intelligence reports, and novel-capsid in-licensing landscape work. Used by investors evaluating a thesis, by founders pressure-testing a deck before fundraising, and by platform companies identifying prospective sponsors and counterparties for in-licensing or co-development.

SME Support for CDMOs, Tools & Technology Companies

Helping platform companies, raw-material suppliers, analytical providers, and CDMOs frame their offering in the language their early-stage biotech buyers actually use. CMC subject-matter expertise for sales conversations, technical positioning for marketing collateral and investor materials, and voice-of-customer translation between R&D-led organizations and the operationally-driven sponsor teams they're trying to win.