Senior expertise, lean pricing
The same caliber of CMC thinking a Series C company would get from a global consultancy — scoped, sized, and priced for pre-seed spinouts, nonprofits, and seed-stage biotechs.
ViroSpark BioConsulting partners with early-stage gene therapy teams — from pre-seed academic spinouts to Series B companies — to make phase-appropriate CMC decisions that protect runway and accelerate the path to first-in-human.
Senior, embedded CMC expertise priced for start-ups, nonprofits, and lean teams — not for global pharma. Not a giant consulting shop. A practical operator who parachutes in, de-risks the program, and hands back a clean plan.
It's the stretch where early choices around process, partners, materials, and documentation can quietly set a program back by months. Most early teams either go to CDMOs directly because they think they can't afford CMC guidance — letting the CDMO make decisions for them — or they pursue faster pathways overseas without fully understanding the path back. Both can work. Both can also create costly rework, weak CMC packages, and delays in lot disposition that burn runway.
There's a real gap between hiring a global CRO/consultancy at six-figure retainers and trying to figure out CMC alone. ViroSpark was built specifically for the start-ups, nonprofits, platform groups, and academic spinouts living in that gap — and for the investors who back them.
The same caliber of CMC thinking a Series C company would get from a global consultancy — scoped, sized, and priced for pre-seed spinouts, nonprofits, and seed-stage biotechs.
I've actually run the function. I parachute in for 2–4 weeks, de-risk the program, and hand back a clean plan — then stay engaged as much (or as little) as the program needs. No layered teams, no junior-staffed deliverables.
Platform companies, nonprofits, foundation-funded programs, and academic spinouts often don't fit standard CDMO playbooks. I've helped these groups navigate CDMOs, plasmid sourcing, and early CMC decisions on their own terms.
Hands-on company-creation experience — out-licensing, in-licensing, and investor diligence. I know what good capsids and credible processes actually look like, and I can pressure-test a CMC story before a partner or VC does. De-risk a bad investment before it happens.
Seven interconnected service areas — chosen, scoped, and sequenced to your program's stage, capital position, and clinical pathway.
Phase-appropriate CMC plans tied to clinical milestones, capital plans, and target product profile — so process, analytics, and supply scale together.
Learn more →RFP design, technical diligence, contract structure, and ongoing oversight — making sure the CDMO is delivering what your program actually needs.
Learn more →Upstream / downstream PD strategy for AAV, lentivirus, and engineered capsids. Tech transfer planning that survives the bench-to-GMP handoff.
Learn more →Module 3 authoring and review, comparability strategy, control strategy, stability — packages that hold up to FDA scrutiny without re-work.
Learn more →IIT planning, IIT-to-IND bridging, ex-US partner selection, and the CMC strategy required to bring data and material back to a US program.
Learn more →Discovery-stage decisions that protect manufacturability for AI-designed and rationally engineered AAV capsids — before they become expensive problems.
Learn more →ViroSpark engagements are scoped to fit lean, capital-conscious early-stage developers. We deliver decisions, documents, and defensible CMC positions — and we open the right doors across our CDMO, technology, and supplier network so the right partner is in the room from the start.
See How We EngageHonest assessment of where your program is — process maturity, gaps in documentation, CDMO relationship health, regulatory posture.
What needs to be locked now vs. deferred. What can wait without breaking IND, and what absolutely cannot.
Strategy memos, CDMO scorecards, Module 3 sections, comparability protocols — written to be defensible, not decorative.
ViroSpark is built around early gene therapy sponsors — but the same operator experience and the same network are equally useful to the people sitting on the other side of those programs. Three audiences, one practice.
An honest read on capsid manufacturability, process maturity, and CMC risk before the term sheet is signed or the deal closes. Both-sides-of-the-table experience — out-licensing, in-licensing, and biotech founding — means I know what credible CMC stories actually look like, and where they tend to break.
VC & licensing advisory →Helping CDMOs and analytical providers 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 translation between R&D-led organizations and the operationally-driven sponsor teams they're trying to win.
CDMO & provider advisory →Modality-choice analyses, market intelligence reports, novel-capsid in-licensing landscape work, and prospective-sponsor mapping for platform and technology companies. Built on years of running the buyer side of the same conversations.
Tools & tech advisory →A large part of the work is matchmaking. Over a decade of building viral vector programs has put me in active, ongoing relationships across the gene therapy ecosystem — CDMOs, technology providers, and raw material suppliers. I know what each one is genuinely good at, where they struggle, and where they're investing next. That's how we figure out what your program actually needs and who can get you there.
US and ex-US viral vector CDMOs across transient, stable, and adjacent platforms — at multiple scales and capacity tiers.
Process technology and equipment vendors across upstream, downstream, fill/finish, and analytical — including emerging platforms.
GMP plasmid, AAV helper systems, media, resins, single-use components — supply qualification and second-source planning.
Capsid characterization, potency, sequencing, and release testing — including specialists for engineered capsid programs.
The result for sponsors: faster, better-informed selection decisions; honest visibility into who's right (and who isn't) for your specific modality and stage; and a partner who's still on the call after the contract is signed.
A PhD molecular virologist and CMC/TechOps operator with 10+ years building viral vector and complex biologics programs from research through IND and first GMP supply. Prior to founding ViroSpark, Michael held CMC & TechOps roles at Affinia Therapeutics and Ring Therapeutics (Flagship Pioneering), driving viral vector strategy across engineered AAV capsid and novel viral vector platform programs.
Michael has also worked in company creation — on both sides of the deal table, out-licensing and in-licensing — so he knows what good capsids and credible processes look like to investors and partners, and can pressure-test a CMC story before a VC does. A large part of his week is spent maintaining the network that surrounds early programs — CDMOs, technology companies, and raw material suppliers — so sponsors get honest answers about who fits their modality, stage, and timeline.
Practitioner writing for the developers, founders, and investors who have to make these calls in real time, on real budgets.
Where AI-designed and rationally engineered AAV capsids break the platform assumptions early teams quietly rely on — and what to do about it.
Capsid access is the start, not the finish. A sponsor-side playbook for sequencing the decisions between capsid in hand and IND submission.