Frequently asked questions.

Our Services and Engagement Process

What services does your firm offer?

We provide comprehensive, hands-on solutions designed to make your cell therapy commercially successful. We don't just advise; we partner with you to solve the toughest challenges. Our service models include:

1. Core Consulting & Strategy:

  • Strategic Product Definition & De-risking: We help you define a commercially viable product profile from day one.

  • Forging Bulletproof Processes (Process Noise Elimination): Our core offering. We apply our methodical approach to hunt and eliminate the process noise that causes batch failures and stalls programs.

  • Human-Factors Engineering & 'Build Cell' Design: We bring lean manufacturing principles to your lab, optimizing the benchtop workflow to reduce operator-induced variability.

  • Pragmatic Manufacturing & Automation Roadmaps: We develop realistic, stage-appropriate plans that prepare you for scale without over-engineering too early.

  • Avoiding the Automation Trap: Smart Implementation: We guide you on how and when to automate, ensuring you invest in technology that solves problems, rather than just making them permanent.

  • Building the Investor-Ready Business Case (ROI & CoGS): We help you translate your technical process into a compelling financial narrative for investors and leadership.

  • Embedding a Manufacturing-First Mindset (Team Training): We deliver our targeted training modules to upskill your scientists and create a culture of manufacturing excellence.

2. Fractional Engineering Resources: We embed our experienced cell therapy professionals directly into your team. This provides the senior-level expertise you need without the overhead of a full-time hire. Our team members act as an extension of your own, infused with our firm's entire knowledge base and pragmatic, hands-on philosophy.

3. Fixed-Price Project Engagements: For well-defined challenges, we offer fixed-price packages. This provides predictable budgeting and clear deliverables for projects like Process Noise & Robustness Assessments, Automation Readiness & Trap Analysis, or developing a "Build Cell" implementation plan.

4. Training & Capability Building: We offer comprehensive training programs, from our video series to custom, on-site workshops, all designed to build lasting manufacturing expertise within your own team.

How does your fractional resourcing model work?

Our model is designed to provide surgical expertise precisely when and where you need it. It’s built on five principles:

  1. Surgical Expertise, On-Demand: Engagements are flexible (often starting at 1-2 days/week) and scale with your needs.

  2. Vetted, High-Impact Professionals: Our team is comprised of seasoned specialists with 3-20 years of direct cell therapy manufacturing experience.

  3. Leveraging Our Collective Knowledge Base: A fractional resource doesn't just bring their own experience; they bring the validated frameworks and collective knowledge of our entire firm.

  4. Embedded Partners, Not Outsiders: We integrate seamlessly with your culture and workflows, working as true partners to your existing team.

  5. Senior-Level Impact Without the Senior-Level Overhead: You get the strategic benefit of a senior engineer or CTO-level expert at a fraction of the cost.

What types of projects are suitable for fixed-price offerings?

Fixed-price projects work best for initiatives with a clear scope and a defined "what good looks like" outcome. Examples include:

  • A comprehensive Process Noise Assessment on your current workflow.

  • An Automation Readiness & Trap Analysis to guide your capital investment.

  • A Human Factors Engineering plan to redesign your lab's 'build cell'.

  • Development of a stage-gate plan for your tech transfer package.

How do you ensure quality and consistency?

Our reputation is built on delivering tangible results, not just reports. Our quality is ensured through:

  • A Unified Methodology: Every project, regardless of model, is guided by our core philosophy of hunting process noise and building pragmatic, robust solutions.

  • Peer Review & Collective Intelligence: Our team operates with a "shared brain." Deliverables and strategies are reviewed internally to leverage our collective experience.

  • Focus on Actionable Outcomes: We deliver clear, unambiguous, and actionable recommendations. Our goal is to empower you to make better decisions and move forward with confidence.

Can I combine different service models?

Absolutely. In fact, most of our clients benefit from a hybrid approach. A typical journey might look like this:

  1. Start with a fixed-price Process Noise Assessment to identify key risks.

  2. Engage a fractional resource to lead the implementation of the recommended changes.

  3. Incorporate a training module to ensure your internal team can sustain the improvements long-term.

We tailor the structure to your specific needs, ensuring you get the right support at the right time.

What is the typical engagement process?

We believe in a collaborative and transparent process:

  1. Deep Dive & Discovery: We start with a thorough session to understand your science, your process, your team, and your commercial goals.

  2. Curating Your Expert Team: We match you with the best-fit engineering resources from our network.

  3. Defining Success & Ways of Working: We co-develop a clear charter with key objectives, milestones, and communication cadences.

  4. Hit the Ground Running: Our team is onboarded with full context, ready to add value from day one.

  5. Continuous Alignment & Value Delivery: Through regular check-ins, we ensure the engagement is delivering maximum value and progressing toward the defined goals.

  6. Building Your Team's Capability: Our ultimate goal is to make ourselves redundant. We ensure all knowledge and processes are continuously transferred to your team, building your internal strength.