The appellate hearing on Samsung Biologics' application for an injunction against its union's strike has concluded, drawing intense industry attention as the court prepares to rule on whether the entire continuous biopharmaceutical production process should be shielded from work stoppages. The appeal follows an April 23 ruling in which the court partially granted the company's injunction request. The central question is whether the judiciary will recognize the biotech industry's defining characteristic — that halting production is tantamount to destroying assets.
In the first-instance ruling, the court acknowledged the unique nature of biopharmaceutical manufacturing and barred the union from striking during certain essential tasks. It excluded cell culture and purification processes from that protection, however, restricting strike activity only for the three finishing and storage processes that complete and preserve the active pharmaceutical ingredient.
Industry observers argue that standard has a clear flaw. The lower court declined to classify cell culture and purification — the processes that directly produce the drug substance — as protected security work, treating only the downstream finishing steps as such. Critics say the court failed to adequately examine whether disrupting those upstream processes would damage production equipment or cause the deterioration or spoilage of raw materials and finished products.
Article 38, Paragraph 2 of the Trade Union and Labor Relations Adjustment Act was enacted on the social consensus that damage to physical means of production must be prevented in order to balance workers' right to strike with employers' property rights. Because halting production in a biotech process directly results in asset disposal, whether the appellate court will incorporate that industrial reality into its legal reasoning is the pivotal issue.
The industry is watching closely because biopharmaceutical manufacturing is a biological process fundamentally unlike conventional manufacturing. From the moment a cell line is thawed, the drug moves through cell culture, purification, quality testing and final formulation in a continuous process spanning roughly 50 to 60 days. Every step depends on real-time control of dozens of variables — temperature, oxygen concentration, nutrient supply and more.
If that chain is broken even once, the cellular growth environment changes immediately and the quality integrity of the batch is irreversibly compromised. A process stoppage does not merely delay production; it renders the drug substance itself unfit for use, effectively destroying the asset. In the biopharmaceutical industry, where products are directly tied to patient lives, deterioration and spoilage must be interpreted differently than they are for ordinary food or raw materials. Even if cells do not physically die or decompose, a batch loses its value as a medicine the moment it deviates from strictly defined manufacturing procedures. What separates acceptable product from spoiled product is not physical appearance but adherence to the prescribed manufacturing process.
Biopharmaceuticals are produced in a highly regulated environment where every step is recorded with rigorous data. If a process deviation occurs — meaning a controlled variable strays outside its designed range — the batch can no longer be guaranteed to meet the regulatory-approved quality standard. Continuous processes require round-the-clock real-time control, so even a brief lapse in oversight can critically compromise process stability and data integrity, making full batch disposal highly likely. If cell culture and purification work is interrupted rather than carried out continuously, abandoned microorganisms and protein aggregate and adhere to bioreactor surfaces, directly causing oxidation and corrosion of the equipment.
Corroded equipment cannot be reused in biopharmaceutical manufacturing. Even after repairs, resuming production requires a suitability assessment and a full quality approval process completed from the outset — a procedure that takes at minimum several months. Should additional union strikes disrupt drug production, the consequences could extend well beyond losses for a single company. Because biopharmaceuticals are often produced and supplied under contracts with global pharmaceutical companies, a prolonged production halt could destabilize the global pharmaceutical supply chain, industry officials warn.
"Supply stability is by far the lifeblood of the contract development and manufacturing organization business," one industry expert said. "If a strike stops the line and causes delivery delays or batch disposal, global big-pharma clients will treat that as a fatal supply chain risk." The expert added that if trust breaks down, customers could redirect orders to competitors or diversify their production bases, ultimately threatening the company's very survival.
silverpaper@heraldcorp.com
