[BioUSA] Leveraging Contract Manufacturing as a Stepping Stone to Contract Development, Samba Dance

Jaeseon Lee, Executive Director of Samsung Biologics CDO Development Team
"Speed is Key to Increasing Market Share in New Drug Development"
"CDO Base Schedule of 14 Months as a Competitive Advantage"
Surpassed Break-even Point in 3 Years, on Path to Success

John Rim, CEO: "CMO Production Capacity Already Catches Up with Lonza"
"Samba's Greatest Strength is Speed"… Emphasizing the Race for Speed

John Lim, CEO of Samsung Biologics, is speaking at a press conference held on the 13th (local time) in San Diego, USA. (Photo by Samsung Biologics)

[San Diego (USA) = Asia Economy Reporter Lee Chun-hee] Samsung Biologics, which has risen to the world's number one company in the contract manufacturing organization (CMO) business sector, announced that it will compete on 'speed' in the contract development organization (CDO) business as well. Through this, it aims to achieve a 'second semiconductor miracle' in the bio field.

"Over 1,000 CDO Orders Accumulated in 4 Years"

Lee Jae-sun, Executive Director of Samsung Biologics' CDO Development Team, emphasized at a press briefing held on the 14th (local time) at the Manchester Grand Hyatt San Diego Hotel in San Diego, California, USA, that "speed is important to increase market share and reduce costs in new drug development." He explained that market share varies depending on the order of market entry, and even a one-day delay in development results in an additional cost of about $600,000 (approximately 773.7 million KRW), making it essentially a race against time.

Lee said, "Samsung Biologics' basic CDO schedule is 14 months," highlighting that they have secured considerable competitiveness. When Samsung Biologics first entered the CDO field, the timeline was 18 to 20 months, but they succeeded in significantly shortening it for single antibody drugs through standardization, unification, and formalization.

This development schedule is similar to that of global contract development and manufacturing organizations (CDMOs) that have been operating in the CDO business. Furthermore, when using Samsung Biologics' CDO acceleration platform 'S-Cellerate,' the average timeline can be shortened to 9 to 10 months.

Lee Jae-sun, Executive Director of the CDO Development Team at Samsung Biologics, is speaking at a press conference related to the CDO business held on the 14th (local time) in San Diego, California, USA. (Photo by Samsung Biologics)

Lee evaluated, "Through this, Samsung Biologics' CDO business succeeded in surpassing the break-even point last year, just three years after starting the business, and has entered a stable trajectory by securing over 1,000 cumulative CDO orders."

In addition, they plan to launch a bispecific antibody CDO platform with significantly improved yield compared to existing production processes through an asymmetric structure in September or October, and by utilizing the 'SBL Developability Service,' scheduled for a second phase launch within the year, they intend to further enhance both quality and CDO speed.

"CMO Production Capacity Already Surpasses Lonza"

John Rim, CEO of Samsung Biologics, also stated at a press briefing held the previous day, "Samsung Biologics' greatest competitiveness is speed," citing the shortest construction period for factories as the secret behind Samsung Biologics' world-largest CMO capacity.

Samsung Biologics' production capacity will reach a total of 620,000 liters once the 4th plant with a scale of 256,000 liters, scheduled for completion next year, begins normal operation, securing a dominant position accounting for 30% of the global total CMO production volume. CEO Rim said, "We managed to build factories in 2 years and 6 months to 3 years, whereas others take 4 years," adding, "In terms of CMO production capacity, it seems we have already overtaken Lonza."

A view of the Samsung Biologics promotional booth set up at the San Diego Convention Center in the United States, where the BIO International Convention 2022 (BIO USA) is being held / San Diego, USA - Photo by Lee Chunhee

Regarding resources for further growth, CEO Rim mentioned Samsung Group's recently announced investment plan of 450 trillion KRW. Samsung Group stated it will invest 450 trillion KRW (360 trillion KRW domestically) by 2026, presenting bio as one of the core businesses.

Rim said, "There is no specific amount decided yet for investment in the bio sector out of the 450 trillion KRW," but added, "Samsung Biologics ranks 4th in domestic market capitalization, which is a message from the market to continue growing, so investment will naturally follow."

He took a cautious stance on new businesses such as cell and gene therapy (CGT), which have recently been a hot topic in the industry. Rim said, "There are not many patients yet," drawing a line by calling it a "small market." However, since there is clearly demand, they plan to respond by building the 5th plant, for which land has been secured next to plants 1 to 4, as a 'Multi Modal' facility capable of producing various pharmaceuticals including CGT and messenger RNA (mRNA) vaccines.

San Diego (USA) = Reporter Lee Chun-hee spring@asiae.co.kr

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