Biotech processes are complicated and always changing, so when designing the cGMP cleanroom, a few simple things need to be taken into account.
Suppose your company or start-up works in cell therapy, tissue engineering, clinical trials, virus-based manufacturing, CAR-T cell immunotherapy, or other areas. In that case, you probably already know that developing a cleanroom for gene therapy can be a complicated process. There is a list of a few things to consider when designing a biotech GMP cleanroom.
The markets for advanced therapy medicinal products (ATMP) and regenerative medicine are growing quickly. The global ATMP market is expected to grow at a CAGR of 12.8% from 2022 to 2027. It was USD 9.37 billion in 2022.
FDA has already given the green light to four therapeutic treatments for patients.
The four main therapeutic modalities are tissue-engineered products, gene therapy, gene-modified cell therapy, and cell therapy.
- Therapy on cells
- Gene-modified cell therapy: In this procedure, cells from the patient (autologous) or a different source (allogeneic) are altered in a lab setting to have a therapeutic effect when administered back to the patient.
- Gene therapy: Using a virus or another method, genetic material is put into the body. This has a healing effect. This fixes the damaged or broken cells in the body so that the patient can get better.
- Tissue-engineered products: These are made by putting together cells or biologically active molecules to fix, maintain, improve, or replace damaged organs or tissues.
There are many variations in how these types of therapies are executed, making it hard for manufacturers to set up their space with cGMP compliance in cleanrooms. Gene and cell therapy cleanrooms need to meet additional sets of quality criteria in addition to ISO standards. They frequently must also adhere to GMP (or cGMP) standards. In order to reduce the possibility of microbiological, particle, and pyrogen infection during the production and sanitation of medical equipment and medications, medical and pharmaceutical producers utilize them.
Here are a few things you should consider when designing a cleanroom for cell and gene therapy:
R&D Lab or Manufacturing on a Large Scale
Do you want to build a small lab for research and development or a large factory? Size has a direct effect on cost.
Whether you want to do research and development, preclinical trials, clinical trials, or mass production, this will affect how your clean areas are set up, how big they are, how they are heated and cooled, and what equipment you put in them.
Know What You’re Doing
“One size fits all” is not true. In a cell and gene lab facility, there are many different kinds of tools. The humidity, temperature, and particles that each step of the manufacturing process needs may be different.
When developing the cGMP cleanroom, you need to think about how to connect the order of the operations and the required level of cleanliness in a way that makes sense. For instance, if two or more steps of a process need an ISO Class 5 environment, you can put them in the same cleanroom space.
ISO Class 5 cleanrooms are a stricter classification of cleanrooms that are used in a smaller number of industries and applications. For your upstream and downstream processes, you really need to know how the different stages of production work.
At least nine different devices have to work together to make the treatment.
Heat and Particles
For making cell and gene biotherapeutics, you need a lot of different kinds of tools in your lab or cleanroom. In the field of gene-modified cell therapy, at least nine different devices must work together to make the treatment. From isolating cells to transferring genes to making formulas and freezing them, you’ll need to know what equipment you’ll need because that will affect how big the cleanroom needs to be.
Also, you need to think about how all of the equipment used to make regenerative medicine will affect the cleanroom’s temperature and the number of airborne particles (contaminants). To provide the cooling needed inside the cleanrooms, the heat gain must be figured out. This will also change the design.
The lead time of the equipment is another critical factor to understand. The lead time for the cleanroom itself may be longer than the up to 24-month delivery time for some equipment. When building a cGMP regenerative medicine facility, the cleanroom can be made with large panels that can be moved out of the way. This makes it possible to install the missing machines when they arrive, after the cleanroom construction is done, without having to wait.
Growth For Future
Regenerative medicine is a growing field, so it’s smart to plan for changes or improvements to the production process and equipment, as well as for the production process to change over time. Changing your cleanroom from a place for clinical trials to a place for commercial production is already a hard job that gets harder if you aren’t ready. To stay in the game, you need to change quickly.
If you want to make gene or cell products, you might need to grow to keep up with demand in the future. When designing, you should keep this in mind. Modular construction makes it easy to add on to, move, or change a room, which is a big plus.
Monitoring the Environment For cGMP
Environmental monitoring is a key part of keeping up with the rules and requirements for making biological medicines. The ISO 14644-1 cleanroom standards and the PIC/s manufacturing area classification use Environmental Monitoring Programs (EMP) to test three parameters. With these three tests, the number of contaminants in the air, on critical surfaces, and on people can be found.
In order to guarantee the quality, security, and efficacy of cell and gene therapy, it is crucial to have a reliable monitoring system in place in GMP cleanrooms dedicated to these biological therapeutics. Also, Advanced Therapies and Medicinal Products (ATMPs) must be carefully watched to recreate the cells’ delicate environment.
As was already said, the Cell and Gene Therapy (CGT) industry changes quickly. It’s important to know that the monitoring devices will be a key part of your future needs and that they must be built into the design to help your production process be flexible and automated.
Most of the time, GMP rules were written without advanced therapies in mind. So, the rules can be a little hard to understand. Since there is no “official” rule for CGT, it is covered by the Good Manufacturing Practices (GMP) and ISO 14644-1 rules.
The rules could change quickly, which could change how you run your cell and gene therapy facility in the future. During the design phase, you must consider how flexible and adaptable the building will be. Recognizing the life cycle of a Good Manufacturing Practice (GMP) product and where delays can happen could help you make a reliable and safe final product more quickly.