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A view of the Celltrion production facility located in Branchburg, New Jersey, USA. Celltrion<\/p>\n
\t\t\t Attention naturally turns to Celltrion. The U.S. facility acquired by Celltrion to build its own production base must also pass the same kind of regulatory scrutiny. In December of last year, Celltrion purchased Eli Lilly\u2019s drug substance (DS) manufacturing plant in Branchburg, New Jersey for $330 million (approximately 467 billion won). Celltrion is currently producing Lilly products under a contract manufacturing (CMO) agreement with Eli Lilly and recorded 50 billion won in revenue from the site in the second quarter.<\/p>\n Celltrion\u2019s larger goal with the plant acquisition is to manufacture its own products. To do this, Celltrion must file an application (sBLA) to add the Branchburg facility as a manufacturing site for the relevant product, undergo pre-approval inspection (PAI) by the FDA, and complete other regulatory steps. Novo Nordisk\u2019s Catalent plant also received a complete response letter (CRL) from the FDA at the manufacturing site addition review stage.<\/p>\n \u2018FDA OAI Track Record\u2019 Poses an Additional Variable for Celltrion Facility<\/p>\n Celltrion\u2019s Branchburg plant also has a regulatory history. According to FDA facility inspection records as of August 12, the Branchburg plant, while under Lilly\u2019s operation, received two OAI ratings during FDA inspections in 2019 and 2020. Although the latest inspection, in 2022, was rated VAI (Voluntary Action Indicated), which is less severe, analysts note that facilities with a history of regulatory findings face more stringent pre-approval inspections and that this could become a variable during new facility registration in the future. <\/p>\n Moreover, because Branchburg is a DS (drug substance) plant, converting it to a manufacturing site for finished goods is even more challenging compared to the Catalent plant. If the production process for the drug substance changes, equivalency testing must be conducted again to prove that the resulting substance is identical.<\/p>\n <\/p>\n Hot Picks Today Celltrion aims to avoid repeating Novo Nordisk\u2019s experience and has been preparing pre-approval procedures for over six months following the acquisition, targeting the start of its own product manufacturing at the plant next year as planned. The company is reportedly focusing its resources on eliminating procedural uncertainties in advance through its local network. A Celltrion official stated, \u201cWe are currently conducting technology transfer and process validation, and as soon as data preparation is complete for each product, we will sequentially submit sBLAs to add the manufacturing facility.\u201d It typically takes from six months to over a year\u2014from filing the site change application, through inspections, to receiving final approval.<\/p>\n
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