Clinical & Commercial Manufacturing

Executive Summary

Mabion offers high-quality manufacturing services in cleanroom classes D, C and B+A, all in compliance with the current GMP regulations. Our dedicated team of specialists recognizes that every drug product has its own peculiarities that require tailored approach towards its development and optimization. Experience and knowledge of our staff in combination with advanced technologies allow us to quickly streamline the process and achieve outstanding performance in terms of timelines and product yield.

Our clients can take advantage of single-use technology, which significantly eliminates the requirement for process validation for cleaning process equipment. Excellent resources and planning capabilities allow for simultaneous production of several batches. Rest assured that thanks to our well-thought procedures for waste disposal, we make every effort to keep the undertaken processes as productive and environmentally friendly as possible.

Please take time to familiarize yourself with the full spectrum of our services:

Upstream processing Downstream Processing Process Validation and Documentation Logistics and Supply Preparation and storage of MCB, WCB and WVB cell banks

“The addition of Mabion’s technical expertise and production capacity to Novavax’ global manufacturing network expands our ability to provide broad access to our vaccine across multiple regions,

We look forward to building a long-term and mutually beneficial strategic partnership with Mabion.”

Rick Crowley, Executive Vice President, Chief Operations Officer, Novavax.

Upstream Processing

Upstream processing requires a high degree of expertise and specialized equipment to ensure the optimal cell growth and productivity. At Mabion we have large experience in working with variety of cell lines, including mammalian, insect and bacterial cell lines. Inoculum stage cell cultures are performed with use of 50 to 5000 mL flasks, while cell cultures in bioreactors are performed at 50 – 2500 L scale.
We carry out the process of separation of cells after culturing from the remaining post-culture fluid in any technology that is preferred by our clients. Thanks to the cutting edge equipment, we can meticulously track culture parameters both in terms of physiological characteristics as well as gas and metabolite content.
Our upstream processing offer includes:

  • Two types of bioreactors: 2 x 200L and 2 x 2000L stirrer tank bioreactors plus 4 x 250L and 2 x 2500L orbital shaking bioreactors, which may be used in a stepwise manner to obtain large product quantities for clinical testing or commercial purposes
  • Protein pharmaceuticals production potential including monoclonal antibodies, protein vaccine antigens and novel modalities such as bispecific antibodies, antibodies for ADC, fusion proteins and other
  • Culturing mammalian and insect cell lines under tightly controlled conditions, with in-depth analysis of culture parameters both in terms of physiological characteristics as well as gas and metabolite content
  • Inoculum cell cultures in local A class
  • Preparation and storage of media and supplements
Technologies / Description Room / Equipment

Up to 7 x 5L flasks

B+A class room

  • Laminar chambers
  • CO 2 orbital-shaking incubators
  • Centrifuges
  • Microscopes

Up to 5000L

D class room

  • FLEX 2 BioProfile cell analyzer and counter
  • 4 x 250L and 2 x 2500L orbital-shaking bioreactors
  • 2 x 2000L and 2 x 200L stirrer tank bioreactors


D class room

  • Stainless steel mixtank 3000 L
  • Medium collection, weight and transportation system


  • Preparation of cells bank in GMP environment
  • Storage of MCB and WCB at ultra-low temperatures (below -150°C) in the gas phase of liquid nitrogen



  • Cold rooms (2-8°C)

Downstream Processing

Downstream processing is a critical part of biologics manufacturing that involves a series of steps designed to purify therapeutic protein and remove impurities. Mabion offers a wide range of protein purification techniques. With our purification process we are capable of obtaining a dozen up to several thousand liters of product in a single batch. We have many years of experience working with multi-use as well as single-use chromatographic systems, including affinity and ion-exchange chromatography in both binding and non-binding modes. Our chromatographic columns and various types of chromatographic deposits are the largest in Poland.
Each day we prepare thousands liters of buffers and solutions (in up to 3000 L tanks). We are also able to prepare all the necessary media and supplements for cell culturing, which gives our company an important advantage of partial self-sufficiency during now common logistics crises. In addition to above services, we can provide our Clients with unique solutions related to buffer and process media transfer.
Our company has a long history of working with viral filtration, sterilization and ultra/diafiltration methods. Moreover, we can store the produced active substance under refrigerated as well as frozen conditions.
Portfolio of our downstream processing services includes:

  • Cell harvest and separation from cells/culture medium via depth filtration and/or centrifugation
  • Protein purification via multitude of methods including:
    • Affinity chromatographies (incl. Protein A, Lentil Lectin)
    • Ion-exchange chromatographies (incl. CEX and TMAE)
    • Ultra/diafiltration
    • Tangential Flow Filtration
    • Nanofiltration and sterile filtration
  • Virus inactivation
  • Formulation into the final drug product
  • Preparation and storage of buffers
  • Storage of the prepared drug substance
Technologies / Description Room / Equipment


D class room

  • Depth filtration FlexAct system with pressure sensors, magnetic mixer, peristaltic pump and scale
  • Product collection, weighing and transportation system
  • Disc stack centrifuge

Low pH

D class room

  • FlexAct system with pH and temperature sensors, magnetic mixer, peristaltic pump and scale
  • Product collection, weighing and transportation system

Protein A with 25L column
Lentil Lectin with 26L column

D class room

  • Stainless steel mixtank 3000L
  • Medium collection, weight and transportation system

Cation-exchange chromatography (CEX) with 63L column
TMAE chromatography with 150L column

D class room

  • AKTA Ready system
  • Product collection, weighing and transportation system

Anion-exchange chromatography in flow-
through mode with single-use columns

D class room

  • FlexAct system with pH and temperature sensors, magnetic mixer, peristaltic pump and scale
  • Product collection, weighing and transportation system

Process Validation and Documentation

Ensuring that the manufacturing process performs effectively and reproducibly within the established parameters is essential to obtaining a safe and potent biologic drug. At Mabion we perfectly understand the critical nature of the process validation and do our best to produce top-quality documentation certifying the adherence to predetermined product specifications and quality characteristics.

Let our high-class specialists take care of:

  • Design and preliminary evaluation of the manufacturing process
  • Qualification of the manufacturing process
  • Continued monitoring through regular testing, analysis, and review of the manufacturing process
  • Validation after introducing changes to the manufacturing
  • Documentation of the process validation in line with ICH guidelines; preparation of the Validation Master Plan (VMP), Validation Protocols and Reports

Logistics and Supply

Mabion’s capabilities do not end with the final product of downstream processing. We also offer filling of the drug products into sterile vials as well as labelling and packaging in compliance with applicable EU regulations (refer to our separate section on Fill & Finish services). The prepared products can be stored in our warehouses in adequate temperature conditions until they are ready to reach their destination. These services finalize the entire manufacturing process that can now be followed by additional assistance from Mabion team related to the quality control and regulatory affairs.
Your business can also benefit from cooperation with our well-equipped Logistics Unit. With its own fleet of vehicles, Mabion team can provide professional transportation services for pharmaceutical products under environmentally controlled conditions, thereby overcoming the need for engaging additional logistics company. We can deliver drug products to almost every European country, including the countries outside the EU. Having many years of experience in clinical trial logistics with thousands of IMPs and more than 25,000 lab samples shipped across 11 countries, we can easily orchestrate transportation of biopharmaceutical products and associated goods in Phase I-III multinational and multicenter trials.

Preparation and storage of MCB, WCB as well WVB and WVB cell banks

In addition to the antibody and vaccine antigen production, our company can carry out the manufacturing processes of cells and virus banking, including generation of MCB/WCB and MVB/WVB. The scope of services includes generation of both microbial and mammalian cell banks. The preparation and storage of cell banks is performed with the use of modern freezing systems. Our offer also includes the conduct of growth tests of the manufactured MCB/WCB and MVB/WVB.

In summary, by contracting Mabion you obtain a true “end-to-end” manufacturing company, which is able to cover the entire lifecycle of biologic drug development, from protein expression to the delivery of the final product.

Together we can create great things

We encourage you to take a look at our offer and if you have any questions, feel free to contact us

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