Developing Canadian biologics with global impact

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The NRC’s lentiviral vector will help advance cancer research around the world

lower half of syringe being inserted into one of the wells of a six well plate containing pink liquid

Immunotherapy is arguably the most exciting development in cancer treatment in decades, adding another option to the 3 traditional treatment strategies of surgery, chemotherapy and radiation. Immunotherapy uses a patient’s own immune cells to attack and kill the cancerous cells in their body. And while immunotherapies such as CAR-T therapy are, for the most part, still at the clinical trial stage, they have shown great success in patients who have exhausted all other treatment options.

Here’s how it works. A patient’s immune cells are retrieved and taken to the lab, where they are reprogrammed to target cancer cells. These boosted immune cells are then re-infused into the patient’s body and delivered to the site of the cancer using a viral vector.

Viral vectors are safe virus particles that serve as the delivery vehicle for the boosted immune cells. One particular type of virus, lentiviruses, are the viral vector equivalent of an airplane. Other vehicles might deliver the same information, but the lentivirus vector is the quickest, most versatile and most efficient delivery tool. Lentiviral vectors have been globally accepted as important components of today’s biologics.

However, just like travelling by air requires a common understanding of time across countries and languages, progress in health research relies on standard and replicable ways of evaluating new medical treatments.

Here's the challenge. There are many applications for lentiviral vectors and many ways to produce them. “Even within the same lab, the concentration of the same stock of lentivirus can differ from one operator to another. The difference from lab to lab can be even more striking,” says Aziza Pryska Manceur, a research officer with the NRC’s Human Health Therapeutics Research Centre.

Despite the broad use of lentiviruses in biologics, there is currently no common language for communicating the quantity and quality of lentivirus vectors being used. And if we’re evaluating the results of different medical treatments, even the smallest variance in the delivery method can make comparison extremely difficult. “It would be much easier to compare the efficacy of immunotherapies if we had a common accepted vector as a benchmark,” says Manceur.

Setting a global standard for immunotherapy research

To help resolve this global challenge, the NRC has developed a consistent lentiviral vector and is planning to make it available to research labs across Canada and around the world.

Manceur and her NRC colleague Anja Rodenbrock led a project to produce a lentiviral vector that can be used as a reference material in all labs conducting research using these viral vectors.

three well plates lined up with samples on a metal conveyor

In order for new biologics to be approved for use, every single dose must be precisely and measurably the exact same as every other dose. The quality of biologics, therefore, is highly dependant on how well the production process can be reproduced at different scales. With more easily comparable test results, it will be easier for regulators to evaluate production processes and make decisions on approving immunotherapies for use in the clinic.

To help create those comparable results, Manceur and her team decided to go “green,” as she explains. “We produced 100 litres of lentivirus in our lab. Our lentiviral vector has a green fluorescent tag, which is easily measurable and will help R&D labs to compare their results to each other.”

Manceur’s team then transferred production of the lentivirus to their colleagues from the purification team, Mehul Patel and Sushma Puttaswamaiah. They purified and concentrated those 100 litres down to just over 4.5 litres, or 18 bags of 250 ml each. These bags were sent to the American Type Culture Collection (ATCC), a biological resource centre whose mission is to supply scientists in more than 150 countries with biomaterials, services and standards to move their research forward. The ATCC will perform a final filtration step and then split the product into 6,000 vials. These will be made available as a reference material and distributed to researchers, industry and others who need it.

By using the NRC’s reference lentivirus vector, labs around the world can ensure the quality and quantity they report is comparable to that of other studies that use the same vector. This consistency will go a long way toward advancing new immunotherapies to treat cancer.

By making it much easier to build on research conducted anywhere in the world, this reference material could also pave the way for immunotherapies targeting other diseases.

Building Canadian biomanufacturing expertise

Manceur is very proud of the impact the NRC’s lentivirus efforts will have in the international effort to cure cancer. In addition, she credits the project for providing long-term benefits for her team’s research.

“We learned vital information about the production process for lentiviral vectors,” Manceur says. “The expertise we’ve gained over the past 4 years with the lentivirus project will help us improve how we manufacture other viral vectors going forward. It also gives us the skills we need to develop new competencies for this and other biomanufacturing processes, which could help reduce the overall cost of immunotherapies. And that is one of our important long-term goals.”

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