Consulting
Process Development
Analytical Services
GMP Manufacturing
Facility Design & Process EngineeringA well-defined CMC strategy accelerates cell and gene therapy development, ensuring regulatory compliance, manufacturing scalability, and commercial success. Build a robust approach with our expert guidance.
Consulting
CMC Strategy
Why is a CMC Strategy Essential?
Developing cell and gene therapies is complex, requiring careful alignment of scientific, regulatory, and commercial considerations.
Without a strong CMC strategy, companies risk costly delays, regulatory setbacks, and manufacturing inefficiencies that can slow progress or derail development entirely.
A well-defined CMC strategy helps to overcome these challenges by ensuring regulatory alignment, manufacturing consistency, and economic viability at every stage.
Our Process
Regulatory Compliance
Cell and gene therapies must meet strict global regulations, including FDA, EMA, and MHRA standards. A well-defined CMC plan ensures alignment from the outset, preventing compliance failures, costly rework, and delays in clinical and commercial progression.
Consistency & Scalability
Reproducible manufacturing is critical for maintaining potency and efficacy. An optimised CMC strategy establishes scalable processes, enabling seamless transition from preclinical to commercial production while ensuring consistent quality across all batches.
Product Quality
Defining critical quality attributes early ensures raw materials, processes, and final products meet stringent safety and efficacy standards. A structured CMC approach enables process validation, reducing variability and strengthening regulatory confidence.
Risk Mitigation
CGT development involves technical, operational, and regulatory risks. A proactive CMC strategy identifies potential failures early, implements mitigation plans, and establishes quality controls to protect against delays, supply chain disruptions, and regulatory hurdles.
Manufacturing Efficiency
Process development and scale-up require careful planning. A coordinated CMC strategy integrates technology selection, facility planning, and process optimisation, reducing costs while ensuring therapies are manufactured efficiently at commercial scale.
Supply Chain Stability
CGTs require controlled logistics and secure storage conditions. A CMC strategy establishes robust supply chain management, ensuring reliable sourcing, temperature-controlled transport, and secure product handling from manufacturing to administration.
Our Approach
We work closely with our clients to develop CMC strategies that are not only scientifically robust but also commercially viable.
Our expertise spans biotech start-ups, established biopharma, and academic innovators, providing tailored guidance that ensures therapies are designed for success from the outset.
Our strategic approach focuses on four key areas that form the foundation of a successful CMC strategy.
Service Benefits
Quality Target Product Profile (QTPP)
Every therapy must meet both patient needs and regulatory expectations. We define critical product attributes early, ensuring that quality, safety, and efficacy are built into the development process.
Integrated Plans
A successful CMC strategy must align product development, manufacturing processes, and quality controls. We create tailored, end-to-end plans that anticipate market demands and regulatory requirements, providing a clear pathway to commercialisation.
Cost of Goods Analysis
Economic feasibility is essential for long-term success. We assess manufacturing costs, process efficiencies, and investment requirements to ensure that CGTs can be produced sustainably and at scale.
Risk-Based Framework
Identifying and mitigating risks early prevents costly setbacks. We help prioritise critical clinical, preclinical, and CMC considerations, ensuring that safety, product quality, and efficacy remain at the forefront of decision-making.
Key Deliverables
Lay the Groundwork for Success
A strong CMC strategy is the foundation of a successful therapy. Whether you’re advancing a novel cell therapy, scaling up for clinical trials, or preparing for commercial launch, we can help you create a roadmap that ensures efficiency, compliance, and long-term success. Contact us today to discuss how we can support your therapy’s journey.
