Successful Tech Transfer of Amphotericin Liposomal Injection to a CMO in the Middle East

Sandeep Kachhwaha
Apr 5
2 min read

Updated: Apr 7

1.Challenge

A Contract Manufacturing Organization (CMO) based in the Middle East, experienced in biologics manufacturing, was selected to produce Amphotericin Liposomal Injection, a complex small-molecule injectable.

However, the CMO faced significant challenges:

Lack of experience in handling complex injectable formulations.
Language barrier: Most staff, including scientists and production personnel, did not speak or understand English, making training and communication difficult.
Complex manufacturing process involving:
- Lipid complex formation with known stability issues
- Spray drying under time constraints to achieve specific particle sizes
- High-pressure homogenization, vial filling, and lyophilization

Scale-up gap: Prior development was done at a 20L batch size, whereas the CMO required a 60L batch. Unlike conventional injectables, complex formulations often behave unpredictably even with scale-up factors.

2. Objectives

Successfully train and handhold the CMO team to manufacture a highly complex product.
Achieve consistent, reproducible results at a larger commercial scale (60L).
Adapt and validate the process with available infrastructure and equipment.

3. Our Approach

✅ Prepared detailed process flow diagrams

Identified equipment and analytical needs
Guided procurement and qualification of analytical instruments

✅ Training & Method Transfer

Conducted foundational training on liposomal technology and characterization
Transferred test methods as per STP (Standard Testing Procedures)
Resolved technical queries promptly

✅ Support at FAT (Factory Acceptance Test) Locations

Assisted CMO during FAT in India and China

✅ Trial Batches

Two batches executed to test feasibility and team preparedness
Emphasis on managing high-volume in-process sampling and analysis
Highlighted gaps in lab handling capacity

❌ Challenges Observed

Analytical discrepancies due to improper sample handling or equipment variance
Lyophilizer lacked control features; validated cycle had to be modified
Adjusted process parameters to match on-site conditions

⚠️ Trust Issues

Process modifications led to perceived R&D activity during tech transfer
Required clear communication and reassurance to CMO management

✅ Final Execution

Post-optimization, three successful validation batches were completed
Stability studies initiated on the final product

4. Final Results

Technology successfully transferred for a complex injectable despite multiple operational and communication hurdles
First international tech-transfer experience—navigated cultural, linguistic, and technical complexities

Overcame interpersonal tension and misperceptions with teamwork, transparency, and technical confidence

5. Key Learnings

Technical expertise alone is not enough. Success requires adaptability, empathy, and cultural awareness.
Unlearning and relearning are essential when working with new teams, technologies, and geographies.
Real-world tech transfer demands flexibility without compromising on quality.

Looking to scale up a complex injectable? Or planning a Tech Transfer in 2025? Let's talk!