This session includes several presentations related to Stage 1 of process validation: process development and design. These presentations include one by GSK on leveraging clinical manufacturing experience to develop a process control strategy, one by Roche-Genentech on accelerated development for a breakthrough therapy product, and a blood product case study which leveraged Stage 1 information.
Senior Director, TL Validation
[Case Study: Stage 1 Process Validation Approaches for an Accelerated Biologic]
Speaker: Thanmaya Peram
Accelerated CMC development is the “new normal”, with a focus on getting transformative therapies to patients faster. This presentation explores process validation approaches that could potentially enable a faster path to submission, and still meet Health Authority expectations. In this case study, prior knowledge and manufacturing experience was used extensively in risk assessments to eliminate stage 1 process validation studies, identify critical process parameters, and establish acceptable ranges for manufacturing. This case study demonstrates that this lean approach can be used to deliver a validated process and complete data package in the initial marketing application for an accelerated biologic. ||
[Leveraging a Robust PV Stage 1 to Ensure Successful PV – A Blood Products Case Study ]
Speakers: Louis Traglia & Diana McCray
The focus of this topic is a case study in preparing a Blood Plasma purification facility for Process Validation runs, with the realized goal of having process performance at or better than the established transferring facility.
Many organizations proceed into process validation runs with high levels of trepidation and concerns over the risk of failures. Each failure in the form of deviations of course raises the risk of overall process failure, resulting in run failures, extra runs, and in the worst cases failure to obtain regulatory release. However, the presenters contend, that a well planned and executed engineering run program, which is used to groom all aspects of the process, can dramatically lower the chance of failure, and give management confidence to move forward.
Comprehensive engineering runs should be used to not only test, but to refine the entire manufacturing process. Our proposed presentation will discuss a successful effort and the comprehensive program that was developed. This presentation is a case study of a greenfield blood plasma purification facility. Ms. McCray, who was the PV lead, will focus her comments on issues around testing and improving the process during the engineering runs. Intermixed with this, Mr. Traglia, who was the overall plant lead for the project will focus his comments on all the other aspects that needed to be groomed in order to ensure that the facility was fully ready for PV runs, and the metrics used to demonstrate readiness. This will include development of the Electronic Batch system, Training and other aspects of the program.
[Leveraging Clinical Manufacturing Experience in Development of the Commercial Process Control Strategy]
Speaker: Phil Smith
For accelerated clinical programs such as those with FDA Breakthrough Therapy designation, product-specific experience in the commercial manufacturing facility may be limited or simply not available when the initial version of the PCS is being developed. This presentation will outline an approach to PCS development for accelerated Biopharmaceutical programs that leverages clinical manufacturing experience in direct support of Process Qualification in the commercial facility.
Attendees will build their understanding of control strategy development, clinical manufacturing, and Process Validation.
Senior Engineer & Group Leader
Commissioning Agents, Inc.
Director, Process Technology