Case Studies: Technology Transfer

Makini Pharma recommended a three-phased approach to address the challenge.

Root-cause Investigation

• The product development report was reviewed to understand the formulation development process and to identify the critical process parameters (CPP) and critical process steps (CPS).
• A gap assessment was undertaken to determine technical discontinuities between laboratory-scale and pilot-scale manufacturing processes. We found that an in-line high-shear homogenizer was used for the homogenization step in the laboratory batches.
• A batch high-shear homogenizer was used for the homogenization step in the pilot batch.

Quality Risk Management

• Product quality risk management was undertaken to determine the potential impact of substituting the in-line high-shear homogenizer for a batch high-shear homogenizer,  on the quality attributes of the finished product. 

Process Development

• Based on the product quality risk management assessment, technical batches were manufactured using the batch high-shear homogenizer.
• Homogenization time for the batch high-shear homogenizer was determined, and an in-process check for the viscosity of the intermediate product was included as a process control measure.

• A pilot batch was manufactured using the homogenization time determined from the technical batches and, the viscosity of the finished product was found to be within the expected range.
• The knowledge and experience learned from the manufacture of the pilot batch was used as a reference in the undertaking of technology transfer.