CAR T-Cell Manufacturing: Production and Guidelines
There are still some major challenges in gene therapy. Two of the biggest ones are scaling-up or -out and optimizing viral vector production.
Fortunately, working with the right manufacturing partner can help reduce these challenges. But what makes a good manufacturing partner in the first place? It depends on the therapeutic you want to produce.
For example, CAR T-cell manufacturing relies on purity. And to produce pure products, labs need to follow cGMP manufacturing standards. That includes having strong quality management systems in place.
What are the best practices when it comes to CAR T manufacturing? And how can your organization benefit from a CDMO partner like Yposkesi? We answer these questions and more.
What Is a CAR T Cell Therapy?
Cell therapy is a quite new field in the pharmaceutical industry. The term refers to the treatment of certain genetic disorders and medical conditions.
For example, CAR T cell therapy alters human immune system cells. Specifically, they alter immune cells via the introduction of CAR-T products. This treatment is well suited to certain types of cancer, including leukemia.
But how exactly do cell therapies like CAR T work? Labs use cells to create organisms called viral vectors. These viral vectors can then deliver genetic material into a patient’s cells.
The genetic information viral vectors deliver is like an instruction for the cell. In the case of CAR T therapies, the instruction goes to the patient’s immune cells. This information helps the patient’s T-cells (a type of immune cell) fight cancer.
CAR T-Cell Manufacturing Best Practices
Producing viral vectors (the organisms that deliver the cell therapy), can be highly error-prone. Manufacturers must know the best practices to help reduce these errors. That way, you can maximize production and profits.
Here are four methods for optimizing viral vector production:
cGMP Practices
cGMP stands for Current Good Manufacturing Practice. cGMP is a requirement for drug manufacturers. The US Food and Drug Administration (FDA) oversees and enforces cGMP standards for the US. Other regulatory agencies are overseeing the cGMP requirements for the rest of the world, for example the European Medicines Agency (EMA) for Europe.
These standards include the following requirements:
- Obtaining high-quality raw materials
- Having thorough operating procedures in place
- Testing products at reliable lab facilities
Following cGMP regulations is important. It is important to stay compliant and avoid production delays. Meeting these requirements can also help your organization save money and scale up.
The FDA also requires gene therapy manufacturers to put good quality management systems in place. We will talk more about this next.
Quality Management Systems
Gene therapy manufacturers must supply safe and effective products. That is why quality assurance systems are so important.
These systems can help manufacturers detect and correct product quality issues. They can also reduce risks in your supply chain.
A good quality management system (QMS) touches all aspects of production. It may include quality control tests, employee training, proper labeling, and auditing. Standardization of production practices also falls under the QMS.
cGMP and the QMS go hand-in-hand. In other words, your QMS should support your good manufacturing practice goals. And your cGMP plan should have a robust QMS.
Regulatory Expertise
Different regions have different regulations around cell therapy and viral vector production. The manufacturer you choose to partner with should have expertise in the regulations that affect your pharmaceutical products.
For example, the EMA has defined guidelines around the development of viral vectors. Labs working with lentiviral vectors have to follow strict production guidelines. We will talk more about lentiviruses later.
Customization
One size does not fit all when it comes to cell therapy. Each product comes with a unique production process. This requires a custom-tailored approach to your manufacturing process.
At Yposkesi, we have four process development labs to customize your production process. We also have four cGMP manufacturing facilities available for our customers.
No matter what product you need, we are ready to design the tailored solution you need.
Yposkesi’s Viral Vector Production Capabilities
At Yposkesi, we specialize in adeno-associated virus (AAV) and lentiviral vector production. Learn more about our services at this link.
Or learn how we use our expertise to overcome the major viral vector manufacturing barriers below.
AAV
Adeno-associated virus (AAV) vectors are one of the most commonly used viral vectors. AAVs are highly versatile. And they do not incorporate the viral DNA into the patient’s genome.
Unfortunately, AAV vectors face big manufacturing challenges. One of the primary challenges is scaling production. And without scale, it is difficult to produce an affordable product for your patients.
At Yposkesi, we have 30 years of experience developing AAV vector manufacturing processes. Our products put out higher volumes and use our proprietary transfection reagents for optimal delivery.
Lentivirus
Lentiviral vectors are derived from HIV viruses. They are ideal therapeutics for immunodeficiencies and diseases of the blood. These viral vectors are the primary source of CAR T-cell production, which we discussed earlier.
Like AAV vectors, lentiviral vectors face some significant manufacturing hurdles. Product purity is critical for a safe therapeutic. Impurities can cause unwanted immune responses in patients who receive these therapies.
Yposkesi has four independent manufacturing facilities available to produce your lentiviral vector-based therapeutics according to cGMP and other regulations.
Need a CDMO to Manufacture Your Cell Therapy Products?
CAR T-cell manufacturing depends on quality producers. Without cGMPs and robust quality management systems, your patients can’t access the high-quality and safe therapeutics they need to live and thrive.
Are you looking for a contract development and manufacturing organization (CDMO)? Yposkesi is one of the largest CDMOs in Europe.
Contact us to learn how we can help you develop the next big thing in cell and gene therapies!