Compliance with Good Manufacturing Practice (GMP) is essential in the development and manufacture of cell and gene therapies, protecting patient safety by ensuring the consistent production of quality products. However, newly upcoming cell and gene therapy institutions can find transitioning, from developmental and clinical testing phases into GMP-compliant manufacturing, challenging, with many experiencing the following issues.
Challenge #1: Meeting and maintaining GMP documentation obligations isn’t easy
Robust documentation is a crucial element of GMP working practices, and understanding the types of documentation required is essential for compliance and qualification. Firstly, to assure consistent and reliable manufacturing conditions, laboratories need evidence from manufacturers that equipment and parts are designed and tested for their intended use, preferably with specific packages of documentation required for particular technologies. Customization may be required depending on individual validated processes, therefore suppliers should always be well informed and have extensive knowledge of the manufacturing requirements for individual therapies.
Furthermore, a wide range of Standard Operating Procedures (SOPs) associated with equipment use are required to be produced by cell and gene therapy laboratories themselves. These SOPs are critical for all GMP-compliant processes and methods, including those associated with cleaning and maintenance. This requirement extends to reagent preparation sheets and reports, as well as usage and calibration logs, clearly specified deviation criteria and specific cleaning protocols, all of which must be regularly reviewed and updated.
Challenge #2: Establishing a robust quality management system can be challenging
GMP is determined to be effective through the successful implementation of a quality management system. Transitioning from research and clinical phases into GMP applications demands extreme focus on quality control (QC) and quality assurance (QA), with an emphasis not only on the rapid and reliable detection of QC issues but also their prevention through robust QA. For many laboratories, this can be time consuming and requires formation of an experienced team with a deep understanding of quality issues as well as managing the potential risks to quality.
In the GMP environment, quality control as much as quality risk management is everyone’s responsibility. However, this can be demanding on resources, requiring regular personnel training and a continuous focus on potential risks to quality. Preparation for quality audits can also be highly involved, taking time away from other responsibilities and putting pressure on teams.
Challenge #3: Sourcing dedicated GMP equipment solutions used to be difficult
Laboratory equipment plays a central role in determining the quality and viability of cell and gene therapy products. However, with no single gold-standard for GMP production line technologies, identifying a dependable partner for dedicated GMP equipment can be challenging. Even products with similar specifications can generate substantially different outcomes due to fundamental differences in design. What’s more, some equipment may be poorly compatible with established cleaning protocols or suffer from design flaws that make it more challenging to control contamination.
Given the variability in products between manufacturers, obtaining documentation on equipment specifications, construction materials, compatibility with various regulations and procedures is critical. Similarly, sourcing factory acceptance test report documentation, including quality control and calibration certifications as well as design qualification is essential for proving equipment meets quality and performance standards. Despite this, not all suppliers routinely provide this documentation.
The solution: Technology vendors are helping laboratories overcome GMP challenges
Thermo Fisher Scientific understands these challenges and has taken steps to make it easier for laboratories working on cell and gene therapy products to meet GMP requirements.
The Thermo Scientific Cell Therapy Systems (CTS) Series Laboratory Equipment is a dedicated range of GMP focused laboratory technologies routinely used in the manufacture of cell and gene therapies. Each product in the CTS Series Laboratory Equipment range is designed to be easy to use, from installation and calibration through to day-to-day operation, cleaning and maintenance. Many of the products also support data recording and connectivity to ensure accurate documentation for compliance and traceability.
Products in the CTS Series Laboratory Equipment range are accompanied by a factory acceptance test documentation package that serves as a hub for GMP documentation, helping to accelerate the transition from research to GMP manufacture. This is supported by Thermo Fisher’s field compliance services, including installation qualification, operation qualification (IQ/OQ), performance maintenance (PM), emergency services and ongoing requalification. By providing the GMP-focused technologies, documentation and service support that laboratories need in an all-inclusive package, solutions such as the CTS Series Laboratory Equipment range are helping organizations accelerate the development of cell and gene therapies.
Discover how your organization can ease the path to GMP compliance
Learn how dedicated GMP solutions are helping institutions and start-ups overcome key challenges in cell and gene therapy manufacturing by watching this on-demand webinar.