Commercial Manufacturing of Autologous Muscle Derived Cell (AMDC) products
Challenge from the Client
Multiple challenges were presented for this effort. Primary challenges involved:
- Renovation of an existing manufacturing facility,
- Demonstrating that the facility, systems and equipment were fit for intended use for compliant commercial manufacturing operations through application of a comprehensive commissioning and qualification program.
- Providing program management, compliance, and project controls support for a multi-faceted, facility renovation project.
- Providing compliance, design, and project delivery consulting support to assist in transition from a capital project environment to CGMP-compliant commercial manufacturing operations for AMDC products.
- Providing SME-level analysis and evaluations of manufacturing processes, process tickets, and support systems to identify potential gaps & needs for transitioning current manufacturing operations from preclinical- and clinical-scale, to fully CGMP-compliant commercial manufacturing operations.
Our Approach & Solution
The IPS team applied expert industry knowledge and skills to deliver value to this effort. We provided coaching in many areas to help align procedures, templates, deliverables and activities with current industry practice and guidance.
This ongoing collection of projects will continue through multiple years. Projects include:
- Site CGMP and design assessments of the commercial manufacturing facility, systems and equipment and recommendations for remediation
- Laboratory commissioning
- Site CGMP assessment of the preclinical & clinical manufacturing facility, systems and equipment and recommendations for remediation
- Development of URS's, GMP impact assessments, and maintenance & calibration work instructions for production and lab equipment in the preclinical & clinical manufacturing facility
- Manufacturing Process Quality Risk Assessment
- Compliance support (Commissioning, Qualification, Validation) for the commercial manufacturing facility, involving 1250 documents and 450 test execution activities supporting:
- Building Management Systems
- Warehouse and Logistics areas
- Facility and utilities