It has been nearly 10 years since Samsung Biologics began operations as a full-service provider of cGMP contract manufacturing for the global biopharmaceutical industry. In that time, the Incheon, South Korea-based company has grown to become one of the top global contract service providers in the biopharma industry. Its facilities produce monoclonal and recombinant drug substance and drug product, and integrated services include cell line generation, process development, analytical services, clinical and commercial bulk cGMP manufacturing and fill finish services.

Back in 2011, Dr. Tae Han Kim obtained approval from the Samsung Group to start Samsung Biologics as a new growth engine, building upon the success of Samsung’s engineering, construction, and clean room operations. He has since been at the helm as the founding chief executive officer. During his tenure as CEO, the company has grown from 30 people to over 3,000 as of 2020, and supports the world’s largest biologics manufacturing capacity from a single location.

Dr. Kim’s career with Samsung spans over four decades. During this time, he has played an instrumental role not only in the biopharmaceutical industry but also in several other fields. After obtaining multiple advanced degrees in chemical engineering from the University of Texas at Austin, Dr. Kim began to take on various leadership roles at Samsung. Before starting Samsung Biologics, he served as vice president at Samsung General Chemical, senior vice president at Samsung Total, and executive vice president at Samsung Electronics.

Contract Pharma recently had the opportunity to discuss with Dr. Kim the state of biopharma outsourcing, Samsung’s growth plans and how the coronavirus pandemic is impacting the industry.

Contract Pharma (CP): What are some of the key drivers influencing the biopharma outsourcing market?

Dr. Tae Han Kim: We are observing a significant impact from the current coronavirus pandemic on outsourcing decisions from biopharma companies. Originally the industry believed ‘Less is More,’ using fewer suppliers to maximize efficiency. However, the pandemic has exposed the risks of concentrating on single sources of supply. As a result, pharma/biotechs are revisiting their outsourcing strategy to implement more diversified multi-source channels as a countermeasure.

In addition, due to the surging worldwide demand for COVID-19 vaccines and treatments, companies are looking for external development and manufacturing partners that can help accelerate their COVID-19 candidates to market. This presents us an opportunity to not only demonstrate our agility and execution excellence as a biologic CDMO, but also the privilege to work with the best biotech companies to make life-saving therapies more accessible to everyone suffering from this pandemic.

CP: How can biopharma companies benefit from outsourcing their development and manufacturing?

Dr. Kim: There are several benefits of outsourcing. First, it allows biotech companies to focus on more important areas of their business, such as clinical studies, regulatory affairs and sales/marketing. Second, outsourcing manufacturing to Samsung Biologics can also alleviate the large capital investments needed in plant construction and maintenance. And third, by outsourcing development services, clients can accelerate cell line development all the way to IND filing and related regulatory hurdles.

CP: What are customers looking for from their service providers?

Dr. Kim: Clients want high quality product at competitive cost, delivered on-time. Big pharmas are also looking for reliable second-source partners with innovative technology, capacity, and established track records of successful execution and quality. Emerging pharmas and biotechs look for partners with integrated service offerings that can propose tailored business terms and have the financial stability to ensure continuity of a campaign.

CP: What are some of Samsung Biologics’ business highlights over the past year?

Dr. Kim: We are the fastest growing company in the CDMO industry, and there is still very high growth momentum with our continued client-centric innovations.

Samsung Biologics began as a large-scale contract manufacturing company to provide high quality, cost competitive service. Plant 1 has 30,000L, Plant 2 has 150,000L, and most recently Plant 3 was completed in 2017 with 12 X 15KL large scale manufacturing bioreactors and N-1 perfusion capability. Since then, we’ve added on 2 X 1KL stainless steel bioreactors and 2 X 1KL single-use bioreactors.

At the same time, we recognized the growing need in the industry for development and testing support, and have integrated contract development services and analytical testing capabilities into our comprehensive end-to-end service offerings. Since the launch of our CDO services in late 2017, we’ve successfully partnered for over 50 development projects, invested in the Beacon platform, and developed our own proprietary cell line.

Our partners range from Big Pharmas such as Roche, BMS, and UCB to emerging pharmas like TaiMed, Aprinoia and Vir Biotechnology.

CP: What are the company’s expansion plans for the rest of 2020?

Dr. Kim: In 2020, our plan is to open our first global site in San Francisco, through which we will be able to provide development services in closer proximity to our clients in the U.S. With the rise in DP demand, we’ll be investing in additional lyophilization capacity, and expanding our aseptic filling capabilities even further. Once all our drug substance (DS) capacity are fully contracted in Plant 1, 2 and 3, we’ll begin studying potential plant expansions.

CP: How has the biopharma outsourcing landscape evolved over the past couple of years?

Dr. Kim: In addition to the continued need for large scale commercial manufacturing capacity, the recent trend has also shown a surge in smaller-scale, niche market/orphan drug manufacturing demand. Accordingly, we’ve invested in smaller scale and single-use manufacturing facilities to address these needs.

CP: How do you see the biopharma outsourcing landscape developing over the next several years? What impact will this have on the industry?

Dr. Kim: Due to the high demand to treat illnesses such as Alzheimer’s Disease and novel viruses like COVID-19, the need for large scale manufacturing remains high. As more Big Pharmas diversify sources of product supply, they will have to choose more outsourcing options—a very positive outlook from Samsung Biologics’ point of view.

CP: What are the greatest challenges and/or obstacles in today’s biopharma outsourcing market?

Dr. Kim: While the biopharma industry has had a long history, aging facilities is also definitely one of the issues in the market. Many outsourcing companies have outdated machinery and facilities which cannot accommodate up-to-date bioprocesses and technologies. And it will cost significant capital investments and time to update or renovate them. Samsung Biologics however, has the flexibility of multiple plants and capability to build and validate the most modern cGMP facilities at a rate 40% faster than our competition, allowing us to keep our facilities up-to-date.

CP: What has been Samsung Biologics’ response to the coronavirus pandemic?

Dr. Kim: Samsung Biologics been taking very proactive measures to the COVID-19 outbreak, even before it began impacting the majority of the world outside China and South Korea. We’ve been operating under our Business Continuity Plan to ensure a stable supply chain and operations for uninterrupted services to our clients. Internally, our COVID-19 response team has been closely managing our employee health and safety around the clock, and we are fortunate to report we have had no employee cases confirmed to date.
Additionally, in light of global travel restrictions and social distancing, we have made it possible for our clients to conduct audits and due diligence activities in real time remotely with secure and innovative technology. We’ve packaged this digital platform as “Samsung Biologics Live” which is now available along with other communication resources on our COVID-19 Client Resources website.

CP: How do you see the pandemic impacting the biopharma supply chain?

Dr. Kim: For the few less well-known suppliers, this could serve as an opportunity as companies seek out alternative vendors in case the main vendor is unable to supply the required materials on time. Internally at Samsung Biologics, we have established a supply chain management COVID-19 war room to actively monitor our global supply chain for any potential disruption to our raw materials and service providers. Our diligent efforts in this area have ensured our ability to manufacture and ship our clients’ drugs on schedule without issues of any kind.