For biopharmaceutical companies, gene therapies are an economic challenge. They are expensive to make yet the diseases the treat are rare, so manufacturers tend to charge a lot for them to generate return on investment. But high prices limit access. They can also attract criticism, particularly when it comes to potentially life-saving therapies.
To address this, industry must make production cheaper and, says tech firm Polyplus, viral vector manufacturing is the obvious place to start.
Estimates put the average cost of goods (COGs) for a gene therapy in the $500,000 to $1 million range. Most observers point to the complex processing steps involved as well as the need for viral vectors as major cost components. This interpretation is supported by recent analysis by McKinsey, which suggests the poor scalability of vector production and processing techniques is impeding efforts to make gene therapy manufacturing more cost effective.
Thomas LeJolly, Asia-Pacific (APAC) director at Polyplus, also sees vector production as the core issue.
“The main challenges in gene therapy viral vector manufacturing come from the complexity of the process and how this impacts overall economics. This results in high costs per dose and impacts the time to market for promising therapies.”
Industry strategies to reduce vector costs usually involve either investing in internal capacity—which was the plan adopted by Sanofi in 2020—or partnering with specialist technology providers and contractors.
Recently, Encell, a South Korea-based contract manufacturing organization took the latter approach. The firm teamed up with France-based Polyplus to develop a cost-efficient viral vector production processes.
“Our teams are working together to design optimized gene-therapy viral vector manufacturing processes.” LeJolly tells GEN. Our goal is to create more productive processes that are easier to scale to reduce the cost per dose in manufacturing.”
The aim is to establish next generation production operations for vectors—including both lentivirus and adeno-associated virus vectors—at Encell production facilities in Hanam in Gyeonggi Province, South Korea.
The focus of the collaboration is on improving scalability using platform technologies developed by Polyplus, according to LeJolly.
“We are working on gene-therapy viral vector manufacturing platforms that can easily scale to volumes of 500 to 2000L and potentially higher with a quality by design (QbD) and right first-time approach.”
In addition to reducing costs, LeJolly also predicts the collaboration will help reduce time to market for gene therapy developers that work with Encell.
“By designing the platforms with high quality GMP grade raw materials we reduce the risk in product approval delays due to raw material related regulatory challenges.”