Just 4 Months! Commercial ADC Project PPQ Completed-Newsroom

Intellective Bio has successfully completed three consecutive PPQ (Process Performance Qualification) batches for its first antibody-drug conjugate (ADC) commercial project. This achievement not only represents the seventh PPQ successfully executed by Intellective Bio but also marks a milestone advancement of its ADC platform from process development to commercial-scale manufacturing.

The project encompassed a comprehensive scope including conjugation process development and characterisation, formulation and lyophilisation process development, analytical method development and validation, as well as drug substance manufacturing. From process optimisation to completing three kilogram-scale PPQ batches of drug substance, Intellective Bio accomplished the entire process in just four months, with the three PPQ batches completed within a single month, significantly accelerating the client's path to market. 

Compared with the clinical batch process, the commercial process incorporated key optimisations, replacing ultrafiltration/diafiltration with adsorptive depth filtration, which significantly enhanced the removal efficiency of small molecules during production.

Prior to PPQ execution, the team completed development and validation of all release and in-process control methods. Several methods were successfully transferred from overseas to Intellective Bio's Changshu site, with concurrent validation compliance requirements for both China and US regulatory submissions, thereby ensuring data integrity for global market applications.

Remaining committed to its mission of "Empowering Clients in Pharmaceuticals, Achieving Healthy Living", Intellective Bio looks forward to building upon this project's success to collaborate with more partners, accelerating the development and commercialisation of innovative ADC therapies to bring new hope to patients worldwide.