Seamless Tech Transfer of Propofol Emulsion Injection to a CMO in Gujarat, India

Sandeep Kachhwaha
Apr 7
2 min read

Updated: Apr 14

1. Challenge

The client, a pharmaceutical company based in Gujarat, India, had recently commissioned a manufacturing plant for sterile injectable dosage forms. While they had prior experience producing solution injections for the domestic and veterinary markets, they lacked experience in handling complex emulsion-based injectables like Propofol Emulsion Injection.

Key challenges included:

Lack of technical experience in handling emulsion injectables
Facility redesign requirements for Propofol-specific manufacturing
Inadequate analytical capability for complex product characterization
Absence of a dedicated project management team, requiring end-to-end consulting
Capital constraints impacting equipment procurement
COVID-19 pandemic, causing an 8-month delay during critical phases

2. Objectives

Design a dedicated manufacturing suite and analytical laboratory for Propofol
Support procurement and qualification of key equipment and instruments
Train QC and production staff on STPs and Batch Manufacturing Records
Manufacture 2 trial batches and 3 validation batches at 250L scale
Ensure product stability and compliance with ICH guidelines
Provide technical assistance in dossier compilation for regulatory submissions

3.Our Approach

Project Planning & Infrastructure

Created detailed User Requirement Specifications (URS) for all equipment and instruments
Designed a fully automated manufacturing suite suitable for emulsion processing
Recommended excipient specifications and special storage conditions

Equipment & Training

Participated in FAT and equipment installation to ensure alignment with Propofol requirements
Due to funding gaps, arranged for external analytical labs to support testing

Manufacturing Execution

Conducted two trial batches, followed by three validation batches at 250L scale
Specially designed rotating tray autoclave for terminal sterilization and validated the sterilization cycle

Quality Compliance

Final product complied with BP and in-house specifications
Detected an oxidative impurity in a few batches; root cause identified and CAPA implemented

Tech Transfer Phases
4. Results

Tech transfer completed successfully, despite delays caused by the pandemic

Dossier filed in multiple international markets; approval is expected in 2–3 countries

*Parameter*	*Observed (During Manufacturing)*	*Target (Post-Scale-up)*
Batch Size	250L	500L
Manufacturing Time	5 Shifts for 250L	5 shifts for 500L (increased efficiency)
Production Output	12000 vials	24300 vials
Cost Of Manufacturing	High Cost per Unit	Low Cost per Unit
Oxidative Impurity Levels	Detected in a few batches	Reduced to acceptable levels after CAPA

5. Key Learnings

Not everything goes as planned. COVID-19 was a reminder of the need for resilience and adaptability
Strong collaboration and training led to a robust, reproducible manufacturing process
Temporary delays led to long-term gains in knowledge sharing, relationship building, and team growth
Origo gained an invaluable partner for future CMO support in complex injectables
This project taught Origo the importance of staying focused, professional, and committed, even during crises