San Francisco -- Samsung BioLogics’ newfound focus on small-scale contract development organization services will be the foundation for its plans to draw larger contract manufacturing organization deals, a top executive said Sunday.

“The CDO business will bring in 30 percent of CMO clients by 2030 and 50 percent by 2035,” Yang Eun-young, head of Samsung BioLogics’ CDO business team, told reporters a day ahead of the JP Morgan Healthcare Conference slated for Monday through Thursday.

CDO is the production of biologics ingredients for laboratory research and clinical trials. Once these ingredients get the green light for innovative new drug application and biologics license from health care authorities, they can be used on animals for preclinical trials and controlled group of humans. 

The batch is small at this point, and will become large and money-spinning when it crosses over to CMO deals, which involve commercialization of the drug.

“Being involved from the CDO stage allows us to foresee what CMO deals we are likely have in two or three years. With this foresight, we can build our fourth and fifth plants accordingly,” Yang said.

Using Samsung BioLogics’ CDO and CMO services is a win-win deal for biotech firms also. When a small company decides to move up from CDO level to CMO level production, changing facilities would require technology transfers which alone can cost a year’s time, she noted.

CDO is a tighter race against time than CMO. Which company proves drug efficacy and enters the market first is critical for its business. One or two months make all the difference, Yang said.

Aside from having the manufacturing capacity of 364,000 liters in a single generation, Samsung BioLogics is investing heavily in the latest technologies that would give it the necessary leverage to stay on top of the game.

It has reduced the number of months that it normally takes to bring a drug candidate from discovery to IND filing, from 18 to 14 months. It takes only 11 months for Samsung BioLogics to bring a drug candidate to the state it can be used for clinical phase 1 trials, Yang said, and the company is trying to shorten that further to nine months.

Samsung BioLogics is also the first from Asia to adopt Berkeley Light Beacon, which enables fully automated live cell isolation, selection and screening in nanopens. Cell line development finishes in three months with the use of Beacon -- earlier just the screening part took two months.

Yang said that Samsung BioLogics has benefited Korean biotechs over foreign firms so far, when it selects from the myriad business invitations.

“Epigyny within the Korean ecosystem has been a crucial mission for Samsung BioLogics since 2019,” said Yang, “We currently have 25:75 ratio of foreign and Korean clients for CDO partnerships -- but we will start picking up more global partners from 2021.”

Samsung BioLogics’ plants 1, 2 and 3 are able to cover advanced molecules, not to mention provide them whatever volume they request.

The CDMO currently has 45 CDO partnerships and has helped 47 novel drug approvals of its partnering firms. Innovative biotech firms like GI Innovation, Eutilex and ImmuneOnsia are a few of its partners.

GI Innovtion’s innovative drug designs were the toughest to produce -- but Samsung BioLogics was able to deliver what was asked: monoclonal antibody, fusion protein and bispecific fusion protein, among many others.

GI Innovation CEO Nam Su-youn said that having Samsung BioLogics as the manufacturer and supplier of the company’s innovative drugs was a favorable factor in its solid tumor pipeline licensing deal with Nanjing Simcere Dongyuan Pharmaceutical in November, worth 900 billion won ($779 million).

“Not only was Samsung BioLogics able to identify the best cell line out of thousands, it was also proactively helpful in answering Simcere's inquiries for us,” Nam said, “Simcere officials visited Samsung BioLogics’ plants many times during the business discussions. Having Samsung BioLogics as the manufacturer reduced the business risks.”

Nam and company co-founder Jang Myoung-ho are in San Francisco for the JP Morgan Healthcare Conference to hold business meetings with global big pharmas for developing combination cancer treatment with its cold tumor treatment pipeline GI-101 and its allergy treatment pipeline GI-301.

Half of what Samsung BioLogics three plants churn out now are antibody; the other half being specific antibody therapies. The company is yet to see economies of scale for gene and cell therapies but said it is keenly watching the global research and development trends.

Samsung BioLogics’ CEO Kim Tae-han and Vice President John Rim will make a presentation in the main track of JP Morgan Healthcare Conference on Wednesday.

The company started out in 2011 as a CMO business, but in 2019 it completed the “one-stop solution” services that cover the initial CDO and the later CRO services, providing a one-of-a-kind deal for novel drug development outsourcing.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)
Korea Herald correspondent