Advancing a therapy from lab bench to commercial manufacturing is one of the most exciting and complicated, transitions a life science organization will face. Facilities must scale quickly, documentation must satisfy regulators, and construction often happens while science continues to evolve.
Many teams begin with the same questions:
The right answers aren’t about buying a list of services—they’re about protecting speed-to-market, compliance, and future flexibility.
1. In Regulated Projects, Early Decisions Echo for Years
In GMP environments, choices made during concept design affect validation strategy, staffing models, and operating costs long after ribbon cutting. Equipment layout influences cleaning procedures. Automation architecture shapes data integrity. Utility sizing determines whether the next product fits without another capital project.
Bringing engineering voices in early helps teams:
Waiting until drawings are “almost done” often turns small questions into expensive change controls.
2. Compliance Is a System, Not a Checklist
Many organizations think of CQV as the final phase of a project. In reality, qualification begins the moment requirements are written. User requirements, automation design, and vendor documentation must all speak the same language.
Projects run smoother when teams:
This mindset shortens inspection timelines and reduces the scramble before first batches.
3. No Single Expert Can Do Everything
Life science facilities sit at the intersection of biology, engineering, and regulation. A successful project blends multiple perspectives—process, automation, electrical, CQV, and construction—into one coordinated plan.
The challenge isn’t finding “more consultants,” it’s finding the right mix at the right time:
When these roles work in silos, gaps appear exactly where regulators like to look.
4. Expansions Happen While Facilities Run
Most organizations can’t pause production to renovate a facility. Tie-ins must be scheduled around campaigns, and new systems must coexist with legacy equipment.
Practical planning focuses on:
A good plan respects both the science and the reality of daily operations.
5. The Best Partner Starts With Questions
Before discussing solutions, experienced consultants want to understand:
These conversations shape scope more effectively than any template proposal.
How Bothwell Approaches Life Science Projects
Across biotech, pharma, and cell and gene therapy facilities, we’ve learned that value comes from clarity—not complexity. Our teams support process and bioprocess engineering, automation, CQV, electrical & instrumentation, construction management, and owner’s representation, but always in service of a larger goal: helping clients make confident decisions in regulated environments.
Sometimes that means a single specialist for a short sprint. Other times it’s a full project team guiding a facility from concept through inspection. The starting point is the same—listening first
If You’re Early in Planning, Consider These Next Steps
If you’d like a sounding board, we’re happy to talk through your project—no assumptions, no canned scope, just practical guidance from people who’ve been there.
A Fully Integrated Consulting Framework
Together, these engineering and delivery disciplines create an integrated consulting framework explicitly tailored to life sciences organizations. The right combination of expertise reduces risk, accelerates delivery, and ensures facilities are designed, built, and qualified to operate, comply, and grow—without compromise.
At Bothwell Engineering, our consultants work exclusively in the life sciences industry, supporting the development and manufacture of medicines and therapies that improve patient outcomes. By aligning engineering expertise to each scope of work, we help clients move confidently from lab to manufacturing—and beyond.
Reach out to our team today to see how we can help.
