MabPlex Announces the Successful Launch of a Pre-fillable Syringe DP Production Line
United States PDT, October 18th, 2024
MabPlex is pleased to announce the successful testing and release of the first clinical batch from their new prefillable syringe (PFS) production line, adding more flexibility to the services we can offer our Clients and enhancing our competitiveness in the CDMO market.
Due to improvements in dosing convenience and precision, PFS delivery has become the leading choice for subcutaneous injection of biological products. At present, the MabPlex PFS production line can generate final drug product (DP) in a variety of 1mL options and 2.25mL with a filling speed of up to 400 devices per minute. A 3mL option is in the process of being validated and will be available by Q2 2025.
The new fill/finish line is equipped with high-speed automation, which removes syringe packaging and executes the filling process entirely within a controlled environment. Disposable systems (liquid dispensers, filling lines, needles, et al) are used throughout the filling process, effectively reducing the risk of cross-contamination. All containers are filled by weight using an automated process that provides greater control over product loading.
MabPlex is able to customize PFS formulations according to the needs of each Client and the characteristics of their molecules, scaling these process as needed throughout the clinical cycle and into commercialization.
High-concentration protein formulations present unique challenges to mixing, filtration, and subcutaneous delivery. MabPlex has extensive development experience with these products and can provide solutions for liquid drug product at 150+ mg/mL.
Dr. Xinfang Li, CEO of MabPlex, stated that “At present, MabPlex has completed the development and execution of a number of programs leveraging a pre-filled dosage format, including three high-concentration antibody formulations (150 mg/mL) and two low-concentration recombinant vaccine programs (50 µg/mL). With the validation and commissioning of our PFS fill/finish line, we provide yet more flexibility for our Clients. Minimizing the need to coordinate between multiple providers, MabPlex continues its drive to provide high-quality services from gene sequence to commercialization.”
MabPlex is a CDMO company focused on providing professional, customized, and integrated CDMO services for antibodies, antibody drug conjugates, recombinant proteins, and other biologic drugs. MabPlex is one of the few organizations in the world that can provide comprehensive services across the clinical production of antibody drug conjugates. At present, over one hundred submissions across a wide variety of large-molecule biologics have been successfully completed. With 10+ years of focus on antibody-drug conjugates, a mature technology platform, and an average of 20+ years across CMC team leadership, MabPlex has collaborated with biopharmaceutical companies in China, the United States, Europe, Korea, India, Australia, et al.
