Amid the mounting anticipation for the BIO International Convention 2023, Korean contract development and manufacturing organization (CDMO) companies are strategically positioning themselves to reinforce their stature as global frontrunners in the industry.

According to industry officials, Samsung Biologics, Lotte Biologics, CHA Biotech, and Hanmi Pharm are planning to make a serious push for CDMO orders at BIO 2023 to be held in Boston, Mass., from June 5 to 8.

Industry watchers are closely watching what results Samsung Biologics will yield. The company has already established itself as the country's top CDMO after becoming the first Korean healthcare company to exceed annual sales of 3 trillion won ($2.2 billion) last year.

Samsung Biologics is likely to discuss orders for the remaining capacity at its fourth plant and introduce a timeline for its planned fifth plant with potential clients during BIO 2023.

Samsung’s Plant 4 has been partially operationalized with 60,000 liters, and the company plans to start operation of the remaining 180,000 liters in June.

Samsung Biologics had already confirmed high interest by potential clients in the remaining capacity at its fourth plant.

"Currently, we have signed contract manufacturing agreements for 12 products with nine clients," a Samsung Biologics official said. "We are also negotiating production contracts for 44 products with 29 additional clients."

As the number of clients and the scale of product production increases, industry watchers expect that the fourth plant's utilization rate will fill up quickly.

Samsung Biologics had also announced its intention to begin constructing a fifth plant in the first half of this year to meet the anticipated demand growth.

The company will invest 1.9 trillion won to build Plant 5, which will be the first plant in Bio Campus 2 and will be built to produce about 180,000 liters of biopharmaceuticals, which is similar to the scale of the third plant on Campus 1.

Lotte Biologics to begin searching for CDMO clients in earnest

Lotte Biologics, which gained attention last year when it acquired BMS's Syracuse plant, is also expected to increase its CDMO order activity during BIO 2023.

Lotte Biologics had successfully acquired BMS's Syracuse plant and entered the CDMO market just eight months after its incorporation on Dec. 31 last year.

The company explained that while it takes at least five years to reach commercial production in general when entering the CDMO business, it was able to shorten its time to market to less than one year by acquiring the Syracuse plant, which has a global pharmaceutical company's expertise and quality system.

In addition, the company is considering adding an antibody-drug conjugate (ADC) consignment production service, a clinical substance production culture facility, and a finished drug product (DP) facility to upgrade the Syracuse plant into Lotte Biologics' North American center.

Recently, the company announced that it plans to invest $80 million to secure ADC contract manufacturing facilities and begin full-scale ADC drug production in 2025.

Accordingly, the company plans to focus its efforts on CDMO orders from large global pharmaceutical companies as well as small and medium-sized biotechs at home and abroad, during the BIO International Conference.

Notably, the company expects that it will be able to show positive results during the convention as it recently strengthened the capabilities of the Business Development department, which is in charge of sales within the company.

For example, the company has recruited Kim Kyoung-Eun, who has extensive work experience at leading pharma and biotech companies, as the Chief Business Officer.

"Since the completion of the acquisition of the Syracuse plant in the U.S., the plant has been operating smoothly," a Lotte Biologics official told Korea Biomedical Review. "As we have announced our mid- to long-term plans, including building a domestic mega-plant, we plan to start winning orders from various customers in earnest."

Other Korean companies also seek to boost CDMO biz

Although smaller in scale than Samsung Biologics and Lotte Biologics, CHA Biotech also plans to increase contact with customers by setting up a promotional booth for Matica Biotechnology, its CDMO subsidiary established in the U.S.

Matica Biotechnology specializes in cell and gene therapy (CGT) related CDMOs.

CGT is considered one of the most promising fields in the biopharmaceutical sector, with Frost & Sullivan, a market research organization, expecting the market for CGT CDMO market to grow from 2 trillion won in 2019 to 12 trillion won in 2026.

Against such a backdrop, Matica Biotechnology completed a cell and gene therapy CDMO facility with a 500-liter bioreactor and global-level manufacturing facilities in May of last year.

According to industry sources, the company has already won eight contracts in the second half of last year and is currently in discussions with more than 40 companies, including four global pharmaceutical companies.

The company also plans to break ground on a second plant in the second half of 2024 and has secured a site that is more than double the size of its existing facility and expects to expand production to 2,000 liters upon completion.

Using the new plant, the company aims to expand its business scope to include viral vector process development and production, as well as plasmid DNA and cell therapy production.

Hanmi will also use BIO 2023 to demonstrate its commitment to the CDMO business.

Hanmi had officially announced its intention to actively enter the CDMO business earlier during the 2023 BIO-Europe Spring Conference held in March.

During that time, Hanmi had actively sought out potential partners interested in entering a CDMO agreement for its Pyeongtaek Bio Plant's advanced large-scale manufacturing capacity (up to 12,500-liter).

According to Hanmi, based on finished pharmaceutical products, the Pyeongtaek Bio Plant can manufacture more than 20 million prefilled syringes per year.

The second bio-plant, completed in 2018, still has room for expansion, allowing Hanmi to expand according to new CMO demands flexibly. As a result, the company can quickly respond to large-scale CMO orders from multinational pharmaceutical companies.

Also, unlike other major Korean CMO companies that have facilities based on animal cell culture, Hanmi stressed that its Pyeongtaek Bio Plant is equipped with manufacturing facilities that use microbial cultures, making it possible to quickly and economically mass produce microbial-based biopharmaceuticals.

"During BIO 2023, Hanmi plans to conduct CDMO and new drug pipeline business meetings with global partners," a company official said.