Mabion is a fully integrated CDMO located in central Europe and established in 2007 to develop and support the development of protein-based biotherapeutics, including monoclonal antibodies, vaccine antigens and other complex proteins. With 16 years of experience, Mabion offers an “end-to-end” solution, covering all stages of biologic drug development: from early clone selection and small-scale manufacturing through process scale-up, large-scale manufacturing and quality control down to sterile fill-finish, packaging and serialization, bioanalytics and regulatory support. A combination of broad capabilities and well-qualified, experienced staff makes Mabion a perfect long-term partner for any project involving therapeutic proteins, whether your product is in pre-clinical or clinical development or already commercially available. In addition to long-term partnerships, Mabion can also provide tailored services depending on your needs.
Mabion started its journey as a developer of biosimilars but with such a broad range of experience and capabilities in PD and manufacturing, and with a well-equipped, state-of-the-art facility, we took the strategic decision to become a stand-alone CDMO. Our experience and commitment enabled us recently to participate in the global COVID-19 response by manufacturing multiple protein vaccine batches with an impeccable batch right first time record.
Mabion’s facilities located in central Poland, which operate in full compliance with GMP, GLP, GCP and ISO principles, can run small- and large-scale production of biotherapeutics, providing the Customers with high-quality products at optimal efficiency and competitive pricing. In addition to manufacturing, Mabion’s portfolio includes many other services related to the development of biologic drugs, such as:
• Development and/or optimization of the manufacturing process
QbD-based approach with sophisticated analytics starting from the early stages of process development, process scale-up and transfer.
• Drug characterization and release testing
Analytical method development, validation and qualification in accordance with Ph. Eur. and USP requirements. Broad spectrum of QC analytical testing spanning early in vitro evaluation, comprehensive state-of-the-art molecule characterization, QTPP and biosimilarity studies, as well as release/stability testing of the DS or DS. Product certification on site.
• Fill & finish
GMP-compliant aseptic fill and finish services in the vial format as well as secondary packaging and serialization for a wide range of biologic drug products.
• Regulatory & consulting services (including regulatory interactions and support with MAA application)
Setting strategy for non-clinical and clinical product development, support in scientific meetings with EMA and FDA, oversight of the development process to ensure regulatory compliance, preparing regulatory documentation and supporting the marketing authorization process.
• Pre-clinical and clinical analytics
Development, transfer and validation of bioanalytical methods for the evaluation of pharmacokinetics, pharmacodynamics and immunogenicity of biologic drugs in accordance with the relevant ICH and EU/US guidelines and in GLP certificated environment. High throughput testing of samples from pre-clinical and clinical studies.
Our highly qualified and proactive team of specialists is eager to start working on new projects, showing passion and commitment to providing the ultimate customer experience. The Mabion team would welcome the opportunity to meet with you at Bio-International 2023 to discuss how we can support you in developing and manufacturing your biologic products.
Please come visit us at booth no. 3235
Company objectives:
• Contract development and manufacturing of biologic drugs
• Providing a wide range of high-quality analytical methods
• Expansion of production and R&D pipeline
• Focusing on Customers and new challenges
• Sustainable growth
Mabion started its journey as a developer of biosimilars but with such a broad range of experience and capabilities in PD and manufacturing, and with a well-equipped, state-of-the-art facility, we took the strategic decision to become a stand-alone CDMO. Our experience and commitment enabled us recently to participate in the global COVID-19 response by manufacturing multiple protein vaccine batches with an impeccable batch right first time record.
Mabion’s facilities located in central Poland, which operate in full compliance with GMP, GLP, GCP and ISO principles, can run small- and large-scale production of biotherapeutics, providing the Customers with high-quality products at optimal efficiency and competitive pricing. In addition to manufacturing, Mabion’s portfolio includes many other services related to the development of biologic drugs, such as:
• Development and/or optimization of the manufacturing process
QbD-based approach with sophisticated analytics starting from the early stages of process development, process scale-up and transfer.
• Drug characterization and release testing
Analytical method development, validation and qualification in accordance with Ph. Eur. and USP requirements. Broad spectrum of QC analytical testing spanning early in vitro evaluation, comprehensive state-of-the-art molecule characterization, QTPP and biosimilarity studies, as well as release/stability testing of the DS or DS. Product certification on site.
• Fill & finish
GMP-compliant aseptic fill and finish services in the vial format as well as secondary packaging and serialization for a wide range of biologic drug products.
• Regulatory & consulting services (including regulatory interactions and support with MAA application)
Setting strategy for non-clinical and clinical product development, support in scientific meetings with EMA and FDA, oversight of the development process to ensure regulatory compliance, preparing regulatory documentation and supporting the marketing authorization process.
• Pre-clinical and clinical analytics
Development, transfer and validation of bioanalytical methods for the evaluation of pharmacokinetics, pharmacodynamics and immunogenicity of biologic drugs in accordance with the relevant ICH and EU/US guidelines and in GLP certificated environment. High throughput testing of samples from pre-clinical and clinical studies.
Our highly qualified and proactive team of specialists is eager to start working on new projects, showing passion and commitment to providing the ultimate customer experience. The Mabion team would welcome the opportunity to meet with you at Bio-International 2023 to discuss how we can support you in developing and manufacturing your biologic products.
Please come visit us at booth no. 3235
Company objectives:
• Contract development and manufacturing of biologic drugs
• Providing a wide range of high-quality analytical methods
• Expansion of production and R&D pipeline
• Focusing on Customers and new challenges
• Sustainable growth
Focus Areas
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