Translating laboratory innovation into a scalable, compliant, and cost-effective manufacturing process is a critical step in pharmaceutical product development. We specialize in designing and optimizing manufacturing workflows for complex drug delivery systems—including lipid nanoparticles (LNPs), polymeric carriers, and sterile injectable formulations.

With expertise spanning preclinical through commercial manufacturing, our consulting services help clients build efficient, reproducible, and regulatory-ready processes that align with FDA, EMA, and global GMP standards.

Our Process Development Services

1. Process Design & Parameter Optimization

We develop scalable manufacturing strategies rooted in process science and product integrity.
Includes:

• Identification of critical process parameters (CPPs) and quality attributes (CQAs)
  
  
• Process design for microfluidics, solvent injection, or batch mixing systems
• Optimization of flow rates, mixing speeds, temperature, and solvent conditions
• Equipment selection and process mapping

2. Scale-Up Strategy & Equipment Compatibility

From benchtop to pilot and GMP-scale, we engineer scalable workflows that maintain product quality and yield.
Includes:

• Scale translation strategy (mass balance, residence time, flow dynamics)
• Equipment matching and system specification
• Scale-dependent risk mitigation
• In-process control implementation

3. Process Validation & Documentation

Ensure your manufacturing processes are compliant, reproducible, and inspection-ready through systematic validation.
Includes:

• Process performance qualification (PPQ) protocols
• Batch record creation and SOP development
• Deviation handling, risk assessments, and change control
• Validation report writing and documentation traceability

4. Tech Transfer & Facility Integration

We support seamless integration of processes into internal GMP facilities or external CDMOs.
Includes:

• Tech transfer planning and documentation packages
• On-site support during engineering and GMP batches
• Staff training and facility alignment
• Cross-functional coordination between R&D, QC, and manufacturing teams

Formulation Types Supported

• Lipid nanoparticles (LNPs)
• Polymeric nanoparticles and hybrid systems
• Aseptic liquid injectables
• Emulsions, suspensions, and sterile intermediates
• Small molecule and biologic combination products

Why Choose Us

• Proven track record: Developed processes used for GMP production of LNP-based cancer and vaccine drugs
• Multidisciplinary expertise: Bridging formulation science, process engineering, and quality systems
• Global experience: Supporting CDMO and internal tech transfer in over 30 countries
• Tailored solutions: Customized for your molecule, equipment, and regulatory pathway

Design with Precision. Scale with Confidence.

A well-developed process is your foundation for regulatory success and commercial viability. Let’s build a process that works—every time, at every scale.

📧 Contact us to start optimizing your manufacturing process development strategy.