Amid continued growth in regenerative medicine applications, increasing numbers of biotech start-ups and labs are transitioning beyond fundamental cell and gene therapy research into Good Manufacturing Practice (GMP)-compliant production.
Cell and gene therapies are highly sensitive to deviations in manufacturing conditions, while issues such as cell culture contamination have serious implications for product quality and safety. Compliance with GMP requirements plays a critical role in assuring patient safety by ensuring the production of consistently safe and effective products. Achieving GMP conditions helps manufacturers build quality into their production lines by reducing human variation in manufacturing procedures and maintaining the repeatability and reliability of process steps.
While GMP principles represent the minimum requirements that cell and gene therapy manufacturers must meet to ensure safe and effective products, they are not prescriptive rules. The way in which organizations achieve compliance will depend upon their individual products, processes and personnel, among other factors, and finding the best approach can be challenging.
How can your laboratory equipment help address compliance challenges?
Compliant laboratory technology is a critical component in meeting GMP requirements, as the performance of production equipment will help determine the quality and viability of cell products. In addition to delivering reliable and repeatable results, any equipment used in the GMP environment must be easy to use and to clean to ensure consistent operation, and needs to be supported by clear documentation that defines operation, control, cleaning, maintenance, and training procedures.
However, for laboratories making the transition from basic research to a GMP manufacturing environment, a number of challenges are frequently encountered when sourcing laboratory equipment:
- Variable product quality: With no single gold-standard for GMP laboratory equipment, performance can vary considerably across different manufacturers, leading to inconsistent outcomes.
- Equipment information: Clear documentation for equipment specifications, construction materials, performance, maintenance and control is vital for effective integration of equipment into GMP workflows, but these aren’t always easy to find.
- Quality control documentation: Certificates of conformance are important to qualify that products meet quality and performance standards. However, factory acceptance test documentation may not be available from all suppliers.
- Set-up: Proper testing during installation qualification/operation qualification (IQ/OQ) is critical, yet documentation can be confusing and training may be required to confirm or correct calibrations.
- Cleaning: Cleaning and disinfection of GMP laboratory equipment is vital for ensuring product purity. However, poor compatibility with commonly-used cleaning materials or nonuser friendly equipment design can lead to instrument damage and/or contamination.
How are new technologies easing GMP compliance?
New GMP-focused laboratory solutions are easing the transition from cell and gene therapy research to GMP production by giving teams the technologies, documentation and service support they need in an all-inclusive package.
Thermo Scientific Cell Therapy Systems (CTS) Series Laboratory Equipment provide technologies routinely used in cell and gene therapy manufacturing, including biological safety cabinets, centrifuges, CO2 incubators and controlled rate freezers. Each product is designed to be easy to install, operate and clean in line with GMP requirements, enabling rapid start-up of pre-clinical and commercial cell and gene therapy manufacturing.
All products in the CTS Series Laboratory Equipment portfolio include a factory acceptance test documentation package that serves as a hub for GMP documentation, comprising operating certificates, performance specifications, user guides and technical manuals. CTS Series Laboratory
Equipment models are also backed by high-quality field compliance services, including installation setup, IQ/OQ and other support such as temperature mapping and calibration.
By addressing some of the challenges commonly encountered by laboratories when moving to the GMP manufacturing environment, the CTS Series Laboratory Equipment portfolio is designed to support the delivery of high-quality cell and gene therapies.
Learn the basics of GMP principles and what to look for in lab equipment that works with you
For more information on key challenges when transitioning from research to production in cell and gene therapy watch this on-demand webinar.
This product is intended for General Laboratory Use. It is the customer’s responsibility to ensure that the performance of the product is suitable for customer’s specific use or application