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Establishing a lab in biopharmaceutical fields such as cell and gene therapies can be demanding, requiring swift and efficient setup while meeting rigorous regulatory standards. The FDA's Good Manufacturing Practice (GMP) regulations provide a framework of essential requirements for the methods, facilities and controls used in manufacturing, processing and packaging of a drug product. However, implementing GMP in practice can be complex, with its application varying depending on a laboratory’s specific needs and goals.
Technology Networks recently spoke with Mary Kay Bates, senior global cell culture scientist at Thermo Fisher Scientific, to explore best practices for implementing GMP regulations in the lab. Bates offers valuable insights into overcoming common challenges, laying a strong groundwork for new or transitioning labs, and leveraging both internal and external partnerships to ensure success.
Anna MacDonald (AM):
Senior Science Editor
Technology Networks
Anna is a senior science editor at Technology Networks. She holds a first-class honors degree in biological sciences from the University of East Anglia. Before joining Technology Networks she helped organize scientific conferences.
What are the most common challenges labs encounter when implementing GMP regulations?
Mary Kay Bates (MKB):
Senior Global Cell Culture Scientist
Thermo Fisher Scientific
Mary Kay Bates is a senior global cell culture scientist with Thermo Fisher Scientific, where she provides cell culture and equipment expertise to colleagues and customers across laboratory and cleanroom settings, as well as at conferences.
One of the biggest challenges for labs is transitioning equipment from research use to production under GMP standards. Often, labs use specific equipment that worked okay during their research and development phase, but once scaled to manufacturing, that equipment may not be robust enough. For example, incubators or freezers that worked in a research setting might struggle in a GMP environment, especially with factors like recovery times after opening doors or temperature uniformity throughout the chamber. These performance details aren’t always obvious from specification sheets, so labs may not realize there’s a problem until it’s too late.
Another challenge is ensuring all equipment performs correctly from day one of GMP qualification. We often see labs install equipment and start their installation and operational qualifications (IQ/OQ), only to run into issues when temperature maps don’t meet the manufacturer’s specifications, sometimes due to poor airflow design. If the equipment isn’t performing as expected, it can lead to costly delays, including the need to replace the equipment with the quality models required for demanding production settings. That’s something no institution wants when planning for clinical trials.
Lastly, documentation is a huge hurdle. Production settings need extensive documentation for everything in a GMP environment. It’s important to ensure that the equipment you purchase comes with all the necessary documentation, like certificates of conformity or factory acceptance tests, so you don’t have to spend valuable time chasing down the documentation from the manufacturer.
AM:
Senior Science Editor
Technology Networks
Anna is a senior science editor at Technology Networks. She holds a first-class honors degree in biological sciences from the University of East Anglia. Before joining Technology Networks she helped organize scientific conferences.
What are some key strategies that labs can adopt to ensure they are set up for success from the very beginning, particularly in terms of meeting GMP requirements?
MKB:
Senior Global Cell Culture Scientist
Thermo Fisher Scientific
Mary Kay Bates is a senior global cell culture scientist with Thermo Fisher Scientific, where she provides cell culture and equipment expertise to colleagues and customers across laboratory and cleanroom settings, as well as at conferences.
Start by getting your equipment manufacturer involved early. They can help you understand the specifications and how the equipment will perform in a GMP setting. It’s also essential to ask the right questions. For example, when purchasing a freezer or incubator, ask about recovery times after the door is opened and the uniformity of temperature throughout. This information might not always be provided in a brochure, but it is crucial for passing regulatory audits.
Good documentation can’t be overstated. Ensure the equipment you’re purchasing comes with all the necessary certificates, including factory acceptance tests, material compositions (like stainless steel or borosilicate glass), and even preventive maintenance recommendations. This will save you a lot of time and hassle during audits and clinical trials.
Finally, think about compatibility. Your IT department – whether on-site or an external partner –should be involved early to ensure the equipment’s monitoring and alarm systems work with your facility’s existing infrastructure. Some manufacturers require proprietary software, but others work with multiple systems, making it easier to integrate into your lab’s processes.
AM:
Senior Science Editor
Technology Networks
Anna is a senior science editor at Technology Networks. She holds a first-class honors degree in biological sciences from the University of East Anglia. Before joining Technology Networks she helped organize scientific conferences.
Why are partnerships – both internal and external – crucial for labs aiming to maintain high standards of quality and compliance with GMP regulations?
MKB:
Senior Global Cell Culture Scientist
Thermo Fisher Scientific
Mary Kay Bates is a senior global cell culture scientist with Thermo Fisher Scientific, where she provides cell culture and equipment expertise to colleagues and customers across laboratory and cleanroom settings, as well as at conferences.
Internally, it’s important to involve all relevant departments: process development, production, IT and quality control should be engaged early in the process. For example, IT must ensure that equipment alarms and monitoring systems are compatible with your facility’s building monitoring systems. This early collaboration is essential for smooth integration, as misalignment can cause delays.
Externally, working closely with your equipment manufacturer is just as critical. A distributor account manager may not have the expertise that a manufacturer representative would when it comes to equipment performance and feature details. Manufacturer field engineers can provide essential support during the IQ/OQ process, ensuring your equipment is fully qualified for GMP compliance from the start. For instance, institutes should look for manufacturer factory-trained service specialists who know the designs and equipment models that come with comprehensive qualification documentation and support. Strong relationships with your manufacturer representatives allow for quicker troubleshooting and access to specialized service teams and technical experts. These teams are invaluable for design details that you might have missed, for example, correct secondary sensor placement or equipment calibration, solving issues in hours that might otherwise take weeks for internal teams to address.
AM:
Senior Science Editor
Technology Networks
Anna is a senior science editor at Technology Networks. She holds a first-class honors degree in biological sciences from the University of East Anglia. Before joining Technology Networks she helped organize scientific conferences.
How can labs promote a culture of compliance and responsibility among all personnel?
MKB:
Senior Global Cell Culture Scientist
Thermo Fisher Scientific
Mary Kay Bates is a senior global cell culture scientist with Thermo Fisher Scientific, where she provides cell culture and equipment expertise to colleagues and customers across laboratory and cleanroom settings, as well as at conferences.
Building a culture of compliance starts at the top. When managers and supervisors prioritize proper documentation, training and record keeping, and lead by example, it sets the tone for the entire team. Regular training and clear communication are essential, too. Everyone should understand the “why” behind the regulations, not just the “what.” Strong relationships with manufacturer technical experts and technical resources can help build the right training materials to ensure everyone in the lab feels informed and equipped to implement best practices.
Empowering staff to speak up when they see potential issues is another important piece. When people feel responsible and accountable for their part in the process, they’re more likely to stay vigilant and adhere to GMP standards.
AM:
Senior Science Editor
Technology Networks
Anna is a senior science editor at Technology Networks. She holds a first-class honors degree in biological sciences from the University of East Anglia. Before joining Technology Networks she helped organize scientific conferences.
Looking ahead, what do you see as the biggest challenges and opportunities for labs when it comes to GMP compliance?
MKB:
Senior Global Cell Culture Scientist
Thermo Fisher Scientific
Mary Kay Bates is a senior global cell culture scientist with Thermo Fisher Scientific, where she provides cell culture and equipment expertise to colleagues and customers across laboratory and cleanroom settings, as well as at conferences.
One of the key challenges labs face is adapting to rapidly evolving technologies while maintaining GMP compliance. As labs integrate automation and advanced digital monitoring systems, they must ensure these tools align with their existing IT infrastructure to avoid compliance risks. Compatibility issues, especially when dealing with proprietary software, can create obstacles.
However, there are significant opportunities here as well. Automation can boost efficiency, minimize human error and contaminants and provide real-time monitoring, helping labs maintain compliance more easily. Additionally, having robust documentation can simplify audits and ensure labs are prepared for future regulatory changes. By adopting these technologies thoughtfully, labs can improve compliance and operational performance.
Overall, institutes that succeed in the future will be those that maintain flexibility, staying agile enough to incorporate new technologies while ensuring that all equipment – whether for development, production or quality control – meets the rigorous demands of GMP compliance.