Combating the pandemic has highlighted the importance of the partnership between biopharma organizations and the contract manufacturing organizations (CMOs) that must flexibly handle outsourced production, which can come suddenly and often must quickly be ramped up. For example, to meet the urgent need for COVID-19 related therapies and vaccines early in the pandemic, Thermo Fisher Scientific, a world leader in serving science with annual revenue of approximately $35 billion, had to expand its manufacturing capacity quickly and dramatically at its Greenville, North Carolina plant to meet urgent demand.
Thermo Fisher offers a comprehensive range of industry-leading services for small and large molecule product portfolios, including drug substance and drug product development, viral vector and cGMP plasmid manufacturing, clinical trial services, and commercial-scale manufacturing and packaging. At the plant, the expansion involved adding a whole new production suite and safeguarding quality. Enabling sufficient production flexibility was also required.
As production rapidly increased and other pharmaceuticals were added to the manufacturing lineup, production changes at the plant would be inevitable. The expansion includes a new 130,000-square-foot facility for sterile drug development and commercial manufacturing of critical medicines, therapies, and vaccines expected to be operational by 2022, according to a recent www.wraltechwire.com article.
As part of the expansion, the plant has added to and upgraded its existing Distributed Control System (DCS) to accommodate the production of two vital pharmaceuticals during the pandemic: first, the antiviral drug Veklury® (remdesivir) FDA approved for the treatment of patients with COVID-19 requiring hospitalization, and then a vaccine authorized under EUA, the Moderna COVID-19 Vaccine.
In this effort, a robust DCS is critical. A DCS is a hub of a CMO’s production, conveying, and handling of pharmaceutical products. The DCS’s user interface brings all the data collected from production equipment and the controller’s process and presents it in a highly “human factored” manner for an operator, generating trends, alarms, etc.
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