Driving Innovation in Biotech Manufacturing
As the demand for Cell and Gene Therapy continues to grow, biotech firms must scale their manufacturing capabilities efficiently and in compliance with regulatory requirements. One leading CDMO embarked on a major facility expansion to support this industry-wide growth. To ensure success, they partnered with Bothwell Engineering, leveraging our deep expertise in facility startups, engineering, and GMP compliance.
This case study explores how Bothwell’s team of consultants led the transition from construction completion to full GMP manufacturing readiness, optimizing workflows and accelerating time-to-market.
The Challenge: Scaling for Industry Growth
A top-tier CDMO needed to rapidly expand its Cell and Gene Therapy manufacturing footprint by:
✔ Retrofitting an existing 50,000 sqft facility
✔ Constructing a new 240,000 sqft viral vector manufacturing site
With ambitious timelines and complex regulatory requirements, the client needed a trusted consulting partner to provide:
- Operational Readiness Leadership
- Process and Project Engineering Expertise
- Commissioning, Qualification, and Validation (CQV) Support
- Comprehensive Document Control
Bothwell Engineering was engaged to integrate these critical workstreams and ensure a smooth transition from project execution to GMP operations.
Scope of Work: Key Contributions by Bothwell Engineering
Bothwell Engineering deployed a highly specialized team to execute this project. Our contributions included:
Project Type:
🔹Facility Startup & GMP Readiness
🔹Process Qualification & Equipment Validation
🔹Operational Readiness & Project Management
Engagement Duration:
📅 Multi-year project execution, spanning from construction completion to full GMP manufacturing readiness.
Key Deliverables:
📌 Development and execution of a cross-functional project schedule
📌 Coordination of engineering, CQV, and validation activities
📌 Specification, procurement, and startup of critical manufacturing equipment
📌 Compliance with global regulatory requirements
Our Approach: Methodologies for Seamless Execution
Bothwell Engineering’s proven methodology for biotech facility startup and GMP compliance was critical in delivering results. Our approach included:
🔹 Integrated Project Management – We aligned multiple workstreams to ensure efficient execution and minimized delays.
🔹 Regulatory Expertise – Our team ensured all CQV and compliance requirements were met to facilitate a successful launch.
🔹 Engineering & Automation Support – We optimized facility operations by overseeing equipment selection, procurement, and startup.
By maintaining a cross-functional approach, Bothwell streamlined communication between engineering, validation, and operations, ensuring a seamless transition to full-scale manufacturing.
Results & Impact: Delivering Measurable Success
Bothwell Engineering’s expertise translated into significant operational benefits for the client, including:
✔ On-Time Project Delivery – Ensured readiness for GMP manufacturing without delays.
✔ Enhanced Manufacturing Capabilities – Successfully scaled up operations to 2,000L suspension cell culture.
✔ Regulatory Compliance Achieved – Delivered a fully validated and inspection-ready facility.
✔ Operational Efficiency Gains – Integrated engineering and CQV processes to streamline startup activities.
The Value of Bothwell’s Expertise
Our clients trust Bothwell Engineering because we don’t just consult—we execute with precision, ensuring that complex projects stay on track, on budget, and fully compliant.
Conclusion: Partner with Bothwell Engineering for Your Next Project
Our work enables biotech firms to bring critical therapies to market faster and more efficiently.
📩 Are you planning a facility expansion or GMP transition? Let’s discuss how Bothwell Engineering can support your project.
💡 Connect with us today to learn more!
