Technology Transfer

Pharma Continuum > Research > Technology Transfer

Project

Support the Technology Transfer of a Biotech Sterile Product

1

Problem Statment

- Lack of technical expertise on lyophilization of biotech complex formulation

- Potential stock-out in case of project delay due to low performance of current CDMO
2

Analysed elements

- Manufacturing Process Complexity - QTPP and related QbD approach in development

- Current commercial routine Manufacturing Performance

- Technology Transfer risk management tool

- Best Regulatory Strategy
3

Identified Root Cause

- Lack of development activities with poor process and product understanding, mainly related to lyo cycle development and scale-up

- Lack of risk control mindset during first technology transfer
4

Proposed Solutions

- Develop a Training program to provide the WHY and the HOW of the lyo cycle handling (from development to GMP routine manufacturing)

- Execute a detailed process FMEA including Mitigation actions

- Design and manage a DoE set for the lyo cycle robustness to be included in the new RA File

- Implement the most appropriate PM tools to handle properly the project execution

Opportunity and Benefits

1. Move from Try&Error development approach to a more scientific and optimized DoE philosophy with a well detailed set of procedures and tools to be used for the following projects

2. New set of PM tools implemented in line with Regulations and Industry Best Practices, reducing execution time and risk of failure

3. Clear list of priorities and resources allocation, based on risks and project impact