Flood of Ultra-High-Priced Rare Disease Treatments... "Securing High Productivity Is Key to Success"

Zebahyeop-MIT ILP, Joint Conference Hosted

'Bio Foundry' Ginkgo Bioworks
Bejad Mahdavi Senior Vice President

"Enhancing Pharmaceutical Capabilities Enables Securing Therapeutic Efficacy and Productivity Beyond Sales Cost"

The advancement of cutting-edge bio technologies such as cell and gene therapies (CGT) is bringing about revolutionary outcomes that enable the treatment of intractable diseases previously thought untreatable. However, at the same time, questions are being raised about the feasibility of CGT's success due to its unimaginably high prices, surpassing even housing prices of 2 billion to 3.5 billion KRW.

Bejad Mahdavi, Senior Vice President of Ginkgo Bioworks, is presenting at the 'MIT-Korea Conference' held on the 28th at the Westin Chosun Hotel in Jung-gu, Seoul, jointly hosted by the Korea Pharmaceutical and Bio-Pharma Manufacturers Association and the MIT Industry Liaison Program (ILP).
[Photo by Lee Chunhee]

Bezad Mahdavi, Senior Vice President of Ginkgo Bioworks, emphasized that Ginkgo can solve such challenges at the ‘MIT-Korea Conference’ held on the 28th at the Westin Chosun Hotel in Jung-gu, Seoul, jointly hosted by the Korea Pharmaceutical and Bio-Pharma Manufacturers Association and the MIT Industry Liaison Program (ILP).

Vice President Mahdavi described Ginkgo’s business as "putting an 8,000-pound (about 3.6 tons) elephant into a bioreactor." This is a variation of the American idiom "the 800-pound gorilla in the room," which refers to a situation where someone has so much influence that others do not consider them and they can do whatever they want. Earlier, Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research, likened ultra-high-priced CGTs to this idiom, pointing out that despite their clear effectiveness, their commercial use might be difficult due to the excessively high prices.

Nevertheless, Vice President Mahdavi stressed that when a new modality (therapeutic approach) emerges, to truly grow to the scale of an "industry," it must overcome factors of quality, quantity, and price. In other words, for industrialization, it is necessary to improve therapeutic efficacy while increasing manufacturability (productivity) and securing price competitiveness. He analyzed, "While about three modalities have been added every 20 years in the past, this pace will accelerate in the future. Since they will operate in a much more advanced and complex environment, it will become important to launch products first to secure market dominance along with artisan-level manufacturing processes." He also mentioned that they are building a platform that secures therapeutic efficacy and productivity far exceeding the cost of goods sold (COGS) by enhancing pharmaceutical capabilities.

Gingko Bioworks' Fully Automated Biofoundry
[Photo by Korea Bio Association]

The core of Ginkgo’s technology is the ‘biofoundry.’ By introducing engineering concepts into biology, it is a technology that allows the design of living organisms as if assembling biological components such as life information and genes. In this process, the ‘DBTL’ cycle of Design-Build-Test-Learn is continuously repeated to rapidly and high-throughput plan experimental and manufacturing processes, which is the concept of the biofoundry. Ginkgo’s biofoundry technology was also credited as the driving force behind the rapid development of Moderna’s COVID-19 vaccine. In addition to this, Ginkgo collaborates with pharmaceutical and bio companies such as Novo Nordisk, Biogen, Roche, and MSD (Merck & Co., USA), as well as various bio-related industries including agriculture and chemicals.

Vice President Mahdavi also emphasized that the discovery process of candidate substances should not be omitted for such rapid development. He explained, "The usual bio-manufacturing process is separated from discovery, but it should not be done that way. No matter how high the efficacy is, candidate substance identification and process development must be conducted together to ensure actual mass production feasibility."

In the semiconductor industry, where the term ‘foundry’ is most commonly used, foundry means contract manufacturing organization (CMO). However, Ginkgo’s business area is quite different. Vice President Mahdavi stated, "We do not directly produce commercial drugs. We are a company that develops technologies and platforms that enable smooth and efficient production of pharmaceuticals and other bio products."

Vice President Mahdavi explained Ginkgo’s know-how by citing the example of CAR-T therapy development, stating that the manufacturing process of CAR-T therapies, which usually takes about 14 days, can be accelerated. For third-generation CAR-T, about one million combinations are made depending on variables, and the process to identify which is suitable can be completed in about two days. He also emphasized that by optimizing the process for enzymes used in vaccine development and other processes, production efficiency can be increased about tenfold, which reduces capital investment needed for securing actual production facilities.

This content was produced with the assistance of AI translation services.