Securing Your Manufacturing Capacity During the Pandemic

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Richard Lee, head of the drug product business unit, Samsung Biologics

Lee spoke about the evolution of drug-product contract manufacturing and how the business has transformed in response to the ongoing coronovirus pandemic. He spoke about how COVID-19 affected life in South Korea described changes his company has made in how it approached sales, technology transfer, and manufacturing operations. As he put it, “Everything has changed.”

South Korea was one of the first affected countries from China’s initial outbreak. Its stock market plummeted by 36%, all air travel was canceled, streets were empty, stores were closed, and automobile and manufacturing sites were closed. Hundreds of people lined up at pharmacies to obtain government-issued masks. No one attended weddings or funerals, hospitals were congested with patients, and schools were closed. He emphasized, however, that South Korea instituted an efficient tracking and tracer program as well as drive-through coronavirus testing. Although 11,000 of the country’s 50 million inhabitants were sickened by the virus, the death rate of 2.5% (269 people) was one of the lowest in the world. Asian cultures adjusted to eliminating family-style dining and handshakes — and after a few months, South Korea was able to weather the pandemic without shutting down its economy.

Lee described a number of progressive solutions adopted by Samsung Biologics. State-of-the-art video-conferencing systems were installed in meeting rooms. Clients, customers, and regulators could simulate live virtual facility tours of manufacturing areas. The company cafeteria developed a safe cooking code, and employees were asked to dine separated from others. Thermal monitoring cameras on all facility and campus entrances identified and isolated employees with raised temperatures, and hand sanitizers were placed around the facility. Temperature checks were performed twice a day, and a work-from-home culture gained acceptance among many employees. Electronic surveys at the beginning of every week continue to ask employees about health conditions and whether they have traveled to restricted regions or attended densely populated events.

In addition to the goal of protecting its own employees, Samsung also wanted to ensure that it protected the products it manufactures. Those efforts were rewarded: Lee noted that as of the time of his BIO presentation, none of the company’s 25+ employees had been diagnosed with COVID-19.

A common goal worldwide is development of a cure, for which a surge of COVID-19 clinical trials has begun globally. With increased manufacturing demands, companies are racing to secure commercial manufacturing slots in advance, based on predictions of success. Lee noted that manufacturing capacity will become the most critical element for enabling the world ultimately to triumph over the pandemic.

Such predictions, however, are difficult if not impossible to make with certainty. Along with the need to mass-produce and perhaps stockpile quantities of a vaccine, Lee stressed the importance of securing manufacturing capabilities — including second and third manufacturing options/sites — to allow for flexible and rapid responses. He emphasized that capacity modeling will become the most pivotal tool in the coming years. Beyond drug development itself, the world will depend heavily on product delivery.

Samsung Biologics already has seen an increase in requests from clients for clinical manufacturing capacity related to COVID-19. Lee noted that, because overall has manufacturing doubled since last year and as many countries and health organizations advocate for stockpiling vaccines for the next pandemic, manufacturing demand will continue to grow for the foreseeable future.

Lee outlined Samsung’s plans for expanding its manufacturing capabilities to prepare for future demand. Those plans include adding a third line for commercial-scale manufacturing and fill–finish, a robotic filling line for clinical and small-size batches, and two 42 m2 lyophilizers.

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