ADC and mRNA: A Manufacturing Paradigm Shift
ADCs and mRNA-based therapeutics represent the fastest-growing segments of the global biopharmaceutical market. The global ADC market is projected to grow from $14 billion in 2025 to over $30 billion by 2030.
In 2026, Korea's MFDS announced dedicated manufacturing facility standards and enhanced quality testing infrastructure for these products.
New ADC Manufacturing Standards
1. Dedicated Containment for Highly Potent Compounds
Payload handling areas must meet OEL thresholds of 1 microgram per cubic meterPhysical separation between conjugation and payload manufacturing is mandatory2. Strengthened Conjugation Process Controls
New in-process control standards for drug-to-antibody ratio analysis3. Special Storage Requirements
Storage at minus 20 degrees Celsius or below requiredmRNA Quality Testing Infrastructure
Dedicated mRNA analytical laboratory within the national quality testing agencyStandardized methods for critical quality attributes including dsRNA impurities and capping ratesOfficial test methods for LNP characteristicsInvestment Strategies for SME Biotech
Prioritize CDMO partnerships before building proprietary facilitiesAdopt modular (single-use) systems to spread capital expenditureGovernment programs can cover 30-50% of facility investment costsPursue proactive GMP certification aligned with new standardsKITIM provides one-stop support for next-generation biopharmaceutical manufacturing. Contact KITIM today.
