# ADC bioprocessing | DrugPatents-in-the-last-14days
# ADC bioprocessing
In the last 14 days, #WIPO published a patent application (WO2025155626) on a manufacturing process and purification strategy for two specific antibody-drug conjugates (#ADC): OBI-902 (an anti-TROP2 ADC) and OBI-904 (an anti-Nectin-4 ADC).
💡 The manufacturing of ADCs involves several challenges:
1️⃣ Protein purification: Ensuring the monoclonal antibody is of high purity before conjugation.
2️⃣ Site-specific conjugation: Linking the drug to the antibody in a controlled, reproducible manner to maintain efficacy and minimise heterogeneity.
3️⃣ Drug-to-antibody ratio (DAR): The average number of drug molecules attached to each antibody molecule must be carefully controlled, as it influences pharmacokinetics, efficacy, and toxicity.
4️⃣ Stability and quality: Buffer systems, glycosylation patterns, and aggregation must be monitored to meet regulatory requirements.
💡 Affinity chromatography using Protein A or G is routinely used to purify antibodies by leveraging their Fc-region binding. However, post-conjugation purification—such as hydrophobic interaction chromatography (HIC)—is required to remove unbound drug, aggregates, and other impurities.
💡 This disclosure presents a detailed and refined manufacturing platform for producing clinical-grade anti-TROP2 and anti-Nectin-4 ADCs. By combining well-established purification methods (e.g., Protein A chromatography, HIC) with advanced analytical and buffer optimisation techniques, the inventors have created a reproducible system for producing high-quality ADCs. The emphasis on glycosylation profiling, selective bioconjugation, and post-conjugation purification ensures the structural integrity, efficacy, and safety of the resulting ADCs.
✅ Achieve high purity and batch-to-batch consistency of ADCs
✅ Provide robust analytical frameworks for evaluating ADC quality
✅ Enable formulation of OBI-902 and OBI-904 into clinically suitable pharmaceutical compositions
The inventors of this patent are Ming-Tain Lai, JUN HONG Richard CHOU , Wang Shy-Guey , Huang Chen-Ping , Chou Bing-Cheng , Lin Hsiao-Han , Chen Ying-Shan from OBI Pharma.
#antibody #DrugDevelopment #patent #intellectualproperty
