Mabion cGMP Facility

Mabion cGMP Facility

Mabion is a fully integrated CDMO offering a wide services associated with the development and GMP manufacturing of biotherapeutics, including monoclonal antibodies and any recombinant protein-based products.

About the plant

Mabion is a fully integrated CDMO offering a wide services associated with the development and GMP manufacturing of biotherapeutics, including monoclonal antibodies and any recombinant protein-based products. We offers an end-to-end solution, covering all stages of biologic drug development from CLD through process scale-up and analytics to sterile fill and finish and QC release.

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.

Mabion is of the most suitable solutions for customers who have recombinant protein-based products (including mAb) in their portfolio, manufactured using mammalian cell line culture technology.

Our CDMO offering is dedicated to customers looking for integrated assets and a comprehensive offering with small and medium-sized projects or large-scale manufacturing of biologic drugs.

We are open to customers from North America, Europe, as well as selected Asian markets, requiring plant locations in highly regulated markets.

Our facilities located in central Poland, which operate in full compliance with GMP, GLP, GCP and ISO principles, can run small- and large-scale manufacturing of biotherapeutics, providing the customers with high-quality products at optimal efficiency and competitive pricing.

In addition to long-term partnerships, Mabion can also provide tailored services depending on your needs.

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Certifications

• ISO
• EMA (EU GMP)
• FDA (cGMP)
• World Health Organization (GMP / HACCP)

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Activity

• Abs (Antibodies), ADC & NDC (Antibody-drug), Peptide, protein, hormone & enzyme, Vaccines, BIOLOGICS manufacturing

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Features

• Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human, Veterinary
• Toxicity (OEB classification): 3 (PDE = 100 - 1,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 5 / HPAPI (PDE < 10 µg/day)
• DEA: Schedule V (lowest potential for abuse)
• BSL: 1, 2, 3
• Therapeutic areas: N/A
• Markets: FDA (USA), EMA (EU), PMDA (Japan), Health Canada (Canada), MHRA (UK), ANVISA (Brazil), MFDS (South Korea)

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Batch Size / Reactor

• Small, Medium, Batch, 1 - 100 L, 100 - 1000 L, 1000 - 2000 L

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Services

• Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Preformulation studies, R&D, Formulation / Galenic design, QbD (Quality by Design), Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, ICH Stability studies, Comparability studies, Downstream, Fill&Finish, Cell line development, Cell banking, Sterile product manufacturing, Non sterile product manufacturing, Upstream, Tech transfer, Pilot plant, Formulation mixing, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Bioanalysis, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Primary packaging, Secondary packaging, Labeling, Serialization, Storage, Distribution, GDP, CMC regulatory support, IND (Investigational New Drug aplication) filing support, IMPD (Investigational Medicinal Product Dossier) submission support

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