MabPlex is pleased to announce the completion and launch of our Commercial Antibody Drug Conjugate (ADC) Drug Product Fill/Finish Line! Operations have begun and the first lot has been released in support of key clinical trials.
This production line was engineered to meet the demands of large-scale commercial production requirements in compliance with multiple regulatory agencies (FDA, EMA, NMPA, et al), and features a Syntegon filling line under Class-C conditions, equipped with Syntegon isolators meeting OEB5 requirements.
Three KYOWAC lyophilization units (1 x 40 m² and 2 x 20 m²) provide capacity for ADC DP formulation and fill across multiple vial specifications (10R, 20R, 50R). Large-scale lyophilization brings a tremendous efficiency boost to ADC DP production; a single batch generated from a 40 m² unit will generate up to 50,000 type 20R vials.
Our suite can accommodate single-pump filling or dose in/out functionality. Combined with our optimized component design, this can significantly reduce both product wastage and operating costs.
The system adopts 100% online weight measurement, and an additional load cell is monitored to assess environmental impacts and compensation. This provides dynamic, real-time feedback to maximize filling precision.
All product contact components are single-use and include a Point-of-Use Pre-Sterilized, Integrity-Tested (PUPSIT) filtration workflow that meets the most recent requirements provided by the EU Sterility Annex. Key contact surfaces are treated by a combination of moist heat sterilization and Vaporized Hydrogen Peroxide (VHP) for sterility assurance, and specialized valves at the juncture between isolator and manipulation arm aid in the aseptic transfer of rubber stoppers, further diminishing the risk of contamination.
External cleaning of vials following fill is also automated, preventing process deviations resulting from bottle contact and increasing operator safety. All of these technologies reinforce MabPlex’s rigorous internal training and qualification protocols to ensure maximum sterility assurance for our Clients.
Dr. Xinfang Li, CEO of MabPlex said: “The Formulation/Fill team at MabPlex is highly experienced and has successfully completed over 300 batches of drug product with a success rate of 100%. Our new commercial fill/finish line is dedicated to providing our partners with comprehensive and efficient solutions for bringing their ADC candidates to the international market”
