Yuhan
One-Stop Custom Synthesis Services

Since founded in 1926, Yuhan is a leading pharmaceutical company in Korea that operates one-stop CDMO business as well as pharmaceuticals, consumer healthcare, and animal healthcare. Founded to solve widespread public health problems, the company still believes in making the best medicines and contributing to public health and runs various business divisions. Aligning with this goal, one of its business divisions, a fully integrated CDMO, provides customized services for small-molecule intermediates and APIs. With comprehensive contract manufacturing services offering the promise of quality, consistency, and reliability, Yuhan stands rooted in its integrity and social responsibilities legacy. The Founder of the company, Dr Ilhan New, a pioneering educator, and a devoted social advocate, saw his country’s potential and worked toward advancing the same. While he is gone today, his legacy continues through his company, Yuhan, contributing to the country’s betterment he helped liberate.

While there are several well-reputed CDMOs for the chemical synthesis in Korea, Yuhan positions as a top-tier among those. Korea’s geographical location can be beneficial to customers in the U.S. and EU as they need to diversify the supply chain geographically as part of their strategic supply chain management, who need to secure a CDMO in Asia other than China and India. Due to its location in Korea, Yuhan gets easy access to China to source raw materials quickly, which reduces the overall lead time of manufacturing and supply chain. Since the outbreak of COVID-19 in early 2020, Yuhan has been in an excellent position to maintain operation and business without any interruption, including securing raw materials, continuing manufacturing activities, and delivering products to customers on-time. “The core idea here is that our company can be the gateway for the western pharma companies to expand their business in Asia due to its strategic location and the rich experience,” says Paul Shin, Managing Director, Overseas Business Division, Yuhan.

The company has been working with Top 20 global pharmaceuticals and biotech companies, supporting customers to successfully launch their 27 new chemical entities (NCEs) drug products to the market for the past two decades. Yuhan’s one-stop services offer numerous benefits to customers, which ultimately translates into improved product quality, more efficient processes, and significant savings of time and money.

Well Equipped to Address Customer Needs

Yuhan operates two current Good Manufacturing Practices (cGMP) regulated manufacturing sites in Korea with a total reactor volume capacity of 724m³ and a R&D Center. Two cGMP manufacturing sites provide a wide range of scale from 100L ~ 12,000L reactor volume along with high-pressure and cryogenic reaction, hydrogenation, particle control (e.g., wet milling), potent compound manufacturing, and more. “Our customers prefer Yuhan as a partner for our proactive, extensive and scalability-oriented R&D capabilities, consistent high quality with extremely low deviation rate, good regulatory tracking, commitment and dedication, transparency. Adding a silver lining is our ability to carry forward to a manufacturing scale and supply the product on-time as we commit,” says Shin.

Our extensive and scalability-focused R&D experiences and capabilities have contributed to successful launches of the customers’ drug products to the market on time

On the other hand, Yuhan’s R&D is reputed for nimble and diligent services and provides high quality solution for process chemistry from synthetic route scouting, process optimization and crystal engineering, and analytical method development. “One of our strengths is to provide solutions to manufacturing for those compounds where the synthetic routes are not robust. Our extensive and scalability-focused R&D experiences and capabilities have contributed to successful launches of the customers’ drug products to the market on time,” says Shin. Most of all, the company’s flexibility and commitment to accommodate the customers’ requests, along with prompt response and robust reporting capabilities, gives it a competitive advantage. Additionally, the R&D chemists are stationed 24/7 at the manufacturing site to provide on-site technical transfer along with high quality technical documents and support during pilot production and process validation. “What our clients find unique while partnering with us is the R&D capabilities dedicated to the CDMO, which are the most distinguishing element and position Yuhan as a robust CDMO. Our R&D offers a proactive approach to new small molecules, experiment design, flexibility in with the clinical trial timeline, on-site technical support, and troubleshooting at the manufacturing site,” adds Shin.

Serving Today’s Market Needs

Driven by the growth of the U.S.-based biopharmaceutical companies and customers’ need to optimize costs, there has been substantial growth in the outsourcing sector. Pharmaceutical companies are striving to increase the speed to a competitive market of their new drugs while reducing development and manufacturing costs to avoid high-fixed in-house costs. Here, the rise of small biopharmaceutical companies is creating opportunities to the CDMO market. They have to rely on CDMO to overcome their limited resources, budget, and capabilities, specifically, the R&D work at the early-stage, route-scouting, process optimization, and forward to a manufacturing scale. Most of the time, customers approach Yuhan to overcome challenges such as limited internal resources, budget, rush to timeline, and more. Yuhan CDMO then provides a counter-proposal with several options to the customers to meet their needs between process route-selection, budget, resources, quality, and timeline. “In our experiences, the customers appreciate our suggestions and bilateral communication as they can review several alternatives and come up with the best option,” says Shin.

One of Yuhan’s clients was looking for an efficient and scalable process to manufacture critical intermediates. As the development of a drug progressed expeditiously, the client required an alternative route with more significant commercial potential to meet more considerable API demands. Here, Yuhan joined as one of several CMO partners to develop an agile alternative process that can avoid the use of SMB. “The client had evaluated overall 14 alternative processes to synthesize the key intermediate and finally selected our alternative process as a 3rd generation route that does not utilize SMB.”

Through the 3rd generation route, the first pilot campaign was successfully performed at one of Yuhan’s cGMP sites and delivered to the client on time. This success has led to larger-scale production orders from the client, and Yuhan completed the second pilot and a full-scale campaign at its site.

As a fully-integrated CDMO providing intermediates and APIs, Yuhan marks a unique position for itself in the market. Apart from being awarded as Korea’s Most Admired Companies for the last eighteen years in a row, what distinguishes Yuhan is its intangible assets such as diligent, dedicated, and experienced workforce. Most of the company’s manpower in R&D and manufacturing sites have been working for the CDMO business with a meagre turn-over rate. Yuhan’s R&D has been reputed for nimble and agile services with the flexibility to accommodate the nature of the clinical trial timeline. Also, the company only commits what it can provide rather than giving false promises to clients or rushing with projects and degrading its quality. “Sometimes, we need to make a difficult decision to turn customers away for projects that we cannot commit after considering our resources, availability of manufacturing slots and meeting the timeline. However, in the end, we believe it has generated a robust trust with customers which contributed our customers to return to us that fit to our business model,” mentions Shin. Also, clients enjoy Yuhan’s unique features such as selectivity of a manufacturing scale and equipment, the flexibility of timeline, consistency in quality with extremely low deviation rate as reputed by clients, and unique culture in Korea.

He also mentions the recent-eased funding environment in the market that enables small biotechs to proceed from the early clinical stage to commercial launch affordably. With the increasing number of small pharmas lacking their own resources and capabilities, there is increasing demand on CDMO supporting the whole lifecycle of a drug from development to commercialization. These small companies with the non-robust process have been looking for a nimble delivery from phase II to commercialization while considering yield improvement, scalability, and technical support with speed. Yuhan’s services and offerings are well aligned with these recent trends, specifically its R&D chemists services that focus on nimble PRnD deliverables based on experiences and knowledge of the manufacturing facilities and operation. “Our quality control focuses on securing reliable and robust supply chain for sustainability and quality assurance. And we provide support for the clients’ regulatory filing including the regulatory documentation and the regulatory push back of staring materials. Our manufacturing sites operate number of facilities that can handle potent compounds up to 1 μg/m³ (SafeBridge Category 3A),” adds Shin. In tandem, Yuhan plans to launch an online virtual tour system within the first half of this year to consider travel restrictions by COVID-19 and cost-saving for long-term clients. The system will also comply with the global ESG (Environment, Safety, and Governance) standards, which is becoming important every year.