The role of quality control (QC) is to ensure that any cell or gene therapy that is administered to a patient is safe, effective and meets a pre-defined set of quality parameters. The material must be thoroughly tested after it is manufactured, and over time confirm that the material continues to be effective throughout its intended shelf life.
QC testing is a regulatory requirement. The analytical tests, and the equipment used in those tests, must all be validated in accordance with strict regulatory guidelines.
Quality Control for cell and gene therapies
The nature of cell and gene therapies means that QC can be more challenging than in traditional biopharmaceuticals.
Compared to traditional medicines, cell and gene therapies are likely to be manufactured in small batch sizes, especially in the example of autologous therapies where the patient’s own cells are modified and then administered back into that same patient. The limited amount of the precious material available to perform analytical testing makes QC challenging. Multiple batches of material can also be processed at the same time, leading to a large number of samples to be tested in parallel.
The QC laboratory at the Cell and Gene Therapy Catapult manufacturing centre in Stevenage, UK
Cell and gene therapies also have strict time restraints that are not found in traditional drugs. Cell and gene therapies are made of living materials, which are highly sensitive. While a traditional pharmaceutical product might be frozen or stored at room temperature, at which they are stable over a long period of time, cell and gene therapies might only have a small time window to which they need to get to the patient. Meaning that sample logistics and planning are vitally important.
The novel nature of these therapies means that traditional QC tests may not be the most appropriate techniques for testing cell and gene therapies.
Innovation in Quality Control
New innovations in QC are constantly looking to create faster testing methods, including the development of method for real time release. For example, the conventional sterility testing method takes in excess of 14 days, however, CGT Catapult is currently working with GSK and LGC to develop a novel PCR method which aims to perform sterility assurance within one hour. Read about it here.
Innovators are also employing increasingly automated testing methods. These methods will reduce the chance of human error, as well as provide more reproducible and accurate data. CGT Catapult is looking to automate elements of mycoplasma testing and viral titre.
With these new technologies however, it is important that the regulatory authorities have approved these testing methods.
Quality control at the CGT Catapult manufacturing centre
Recently QC labs have applied ‘lean’ principals using six-sigma approaches to testing and delivering results. The aim is to ensure the equipment, reagents and consumables are organised to deliver results in the most efficient manner. This reduces the time a therapy is in QC, a key requirement for the development of time sensitive cell and gene therapies. This principal is being used to design the QC laboratories at the CGT Catapult manufacturing centre.
The Cell and Gene Therapy Catapult manufacturing centre has central and independent QC labroatories
The Cell and Gene Therapy Catapult manufacturing centre consists of six independent modules, in which collaborators can develop their manufacturing processes. The supportive environment provided by Cell and Gene Therapy Catapult includes central and independent quality control units, and a quality management system that can be integrated into the collaborators module if required.
Find out more about the Cell and Gene Therapy Catapult manufacturing centre here.