Clinical & Commercial Manufacturing

Executive Summary

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

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

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

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.