Purpose
In order to align with the current Federal Drug Administation (FDA) requirements to reduce viral risk associated with the current Unclogerall® purification process at the Boston Production Facility (BPF), a viral clearance filtration step must be introduced into the manufacturing process. The proposed viral reduction step would be added after the last purification column step and prior to the final formulation of the drug substance. A laboratory scale study was completed and concluded that the addition of a viral clearance filtration step to the Unclogerall® manufacturing process reduces the viral risk level to align with FDA requirements for Biotechnology products derived from cell lines of human or animal origin. This memo will describe the new process step and will evaluate the …show more content…
Unclogerall® Manufacturing Process
An initial implementation scope has been evaluated and will be discussed in further detail. The topics addressed include:
• Viral clearance filtration system and operation steps requirements
• Segregation requirements of pre-viral and post-viral process materials and areas.
• Impact and Requirements for Implementation
Viral Clearance Filtration System and Operational Steps
The viral clearance filtration operation is straight-forward and requires the transfer of the in-process Unclogerall® material through a viral filter using a constant differential pressure. An overview of the viral filtration process is outlined in Table 1.
Table 1. Viral Clearance Filtration Steps
Step Number Description Process Overview
1 System Setup • Setup viral clearance filtration system
• Flush the filter and preform pre-use integrity test
• Equilibrate the viral clearance filter prior to product filtration
2 Viral Clearance
Process Step • Pressurize vessel and filter product through viral clearance filter
• Perform inline 0.2 µm sterile filtration downstream of viral filtration • Collect filtered product in collection vessel
3 System
In order to align with the current Federal Drug Administation (FDA) requirements to reduce viral risk associated with the current Unclogerall® purification process at the Boston Production Facility (BPF), a viral clearance filtration step must be introduced into the manufacturing process. The proposed viral reduction step would be added after the last purification column step and prior to the final formulation of the drug substance. A laboratory scale study was completed and concluded that the addition of a viral clearance filtration step to the Unclogerall® manufacturing process reduces the viral risk level to align with FDA requirements for Biotechnology products derived from cell lines of human or animal origin. This memo will describe the new process step and will evaluate the …show more content…
Unclogerall® Manufacturing Process
An initial implementation scope has been evaluated and will be discussed in further detail. The topics addressed include:
• Viral clearance filtration system and operation steps requirements
• Segregation requirements of pre-viral and post-viral process materials and areas.
• Impact and Requirements for Implementation
Viral Clearance Filtration System and Operational Steps
The viral clearance filtration operation is straight-forward and requires the transfer of the in-process Unclogerall® material through a viral filter using a constant differential pressure. An overview of the viral filtration process is outlined in Table 1.
Table 1. Viral Clearance Filtration Steps
Step Number Description Process Overview
1 System Setup • Setup viral clearance filtration system
• Flush the filter and preform pre-use integrity test
• Equilibrate the viral clearance filter prior to product filtration
2 Viral Clearance
Process Step • Pressurize vessel and filter product through viral clearance filter
• Perform inline 0.2 µm sterile filtration downstream of viral filtration • Collect filtered product in collection vessel
3 System