US FDA green light for Samsung BioLogics’ mAb production

By Flora Southey

- Last updated on GMT

The US FDA has granted Samsung BioLogics’ second manufacturing plant another approval for monoclonal antibody production.

Samsung BioLogics’ second facility in Incheon, South Korea – regarded​ as the world’s largest single bioproduction plant – received the manufacturing approval earlier this week.

The contract development and manufacturing organisation (CDMO) did not disclose details regarding the monoclonal antibody (mAb), but a spokesperson told us the approval “allows our clients to quickly supply their products to the market.”

Samsung BioLogics received FDA approval for its first mAb at the site in December last year​, which was followed by the European Medicines Agency’s (EMA) approval​ for the same drug substance.

The firm’s 152,000L facility – commissioned in 2013​ – has recently been joined by ‘Plant 3’, which is expected to surpass Samsung BioLogics’ second plant as the largest biomanufacturing facility in the world.

The $740m facility was completed in December 2017​ and is awaiting validation. The site will add a further 180,000L of capacity, taking Samsung BioLogics’ mammalian cell culture capacity to 362,000L.

The CDMO attracted​ regulatory attention earlier this month when it threatened to sue the Korean government after news of an accounting probe decreased its value by $6bn.

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