Maximising the value and capabilities of laboratory equipment is key to success when it comes to cell and gene therapy. Here, Mary Kay Bates explains how to put performance first when scaling up from research to commercialisation within this complex and dynamic market.
Cell and gene therapy are complex and dynamic segments. From oncology to musculoskeletal applications to dermatology to neurology, recent years have seen the development of sophisticated new therapies to treat a broad range of life-threatening diseases. However, transitioning from the research phase to commercialisation can be particularly challenging, requiring developers to optimise their ever-more complicated production processes, while remaining compliant with detailed current Good Manufacturing Practice (cGMP) requirements.
Maximising the value and capabilities of laboratory equipment is of top priority in alleviating the challenges associated with scaling up and achieving efficient cell and gene therapy commercialisation. This need does not mean scouring the market for the newest and most specialised equipment. Many existing designs that have proven their efficacy and reliability for research applications have already been carefully validated for use in cGMP-compliant environments, meeting the scalability requirements of cell and gene therapy manufacturers.
In the cell and gene therapy space, incorporating thoughtful, versatile equipment design is key to remaining competitive in an ever-evolving industry
Tried and true
As a scientist working with process engineers and project managers to commercialise your discoveries, it’s important to understand that you may already be familiar with a variety of core laboratory equipment that comes complete with validated performance information and documentation. And factory trained service specialists are available to provide comprehensive qualification compliance services, including Design Qualification (DQ), Installation Qualification (IQ) and Operational Qualification (OQ) as well as services supporting Performance Qualifications (PQs). In fact, such equipment is already being used to produce many therapeutic applications. From carbon dioxide (CO2) incubators and centrifuges to cold storage and biological safety cabinets that support clean room requirements, familiar – yet innovative – products can form the mainstay of fast, compliant clinical research and commercial manufacturing.
The importance of good design
There is always room for innovation in the research and development laboratory, but sometimes the most effective process stems from something familiar
In the cell and gene therapy space, incorporating thoughtful, versatile equipment design is key to remaining competitive in an ever-evolving industry. For example, autologous cancer immunotherapy products can be widely varied in quality and performance due to complex workflows and variations in biological parameters, such as patient status and T-cell activity rates. However, limiting variability can be aided by using instrumentation designed with uniformity, recovery and passive contamination control in mind. For a cell culture incubator used in an application like cancer immunotherapy, uniformity ensures cells grow and respond in the same way, regardless of their position within the incubator. Fast recovery of all parameters following a door opening ensures that cells remain at their ideal conditions for maximum health, efficacy and yield.
For instrumentation like a centrifuge, technicians need to have control over cooling and braking cycles to protect and assure cell viability, and each run must have full repeatability to ensure similar results run after run.
The need for control extends to methods of storage. Starting materials, reagents and cells should be stored at stable, uniform temperatures. Final products need to be frozen in a controlled, consistent, step-by-step manner, and are best protected in a controlled-rate freezer designed to accommodate multiple protocol-specific freezing profiles which maintain cellular viability during this critical process.
Biosafety cabinets should be designed to continuously test and adjust their airflow to protect not only the precious cells being manipulated within, but also those working in the laboratory, who may be at risk from latent viruses or oncogenes carried in patient samples.
Always room for innovation
Establishing clearly defined objectives, and knowing how your laboratory instrument specifications and performance can help you meet them, allows you to select the ideal functionality for your laboratory. Everything -- from cGMP documentation to individual instrument parts to entire workflows -- must uphold compliance; this is of particular importance to maintain quality and patient safety even in the fast-paced and changeable landscape of cell and gene therapy.
From the selection of component materials to the environment in which an instrument is manufactured, if quality is prioritised through the stages of equipment design and production, the applied scientific workflows benefit. When equipment is manufactured within an ISO 13485 environment and is accompanied by comprehensive Factory Acceptance Test (FAT) documentation, as well as independent third-party test data demonstrating effective contamination control and other features, this accelerates the path to validation and regulatory acceptance in the laboratory, allowing you to focus on the next steps of the process: developing and producing life-saving therapies.
There is always room for innovation in the research and development laboratory, but sometimes the most effective process stems from something familiar. Relying on tried-and-tested solutions with proven specifications and performance can help you establish efficient and reliable workflows to drive cell and gene therapy scalability, facilitating the fast, robust, compliant delivery of valuable therapies to those who need them most.
Author: Mary Kay Bates, Senior Global Cell Culture Scientist, Laboratory Equipment, Thermo Fisher Scientific