In the Manufacturing Department, we combine scientific knowledge with advanced technology and turn it into innovative projects. Our fundamental activity is the manufacture of sterile biological products. The processes for manufacturing such products consist of several steps of cell culture – from flask to bioreactor, multi-step purification – by filtration and chromatography methods, as well as bottling into glass vials and packaging of the finished product.
We have state-of-the-art process equipment operating with single-use technology, which provides great flexibility in the processes carried out and minimizes the risk of cross-contamination.
Our structure includes a wide variety of disciplines, such as:
– production planning and scheduling,
– sterile production of recombinant protein products (in terms of DS, DP and wrapping and packaging),
– production of cellular and viral banks (including WCB, MCB, WVB),
– validation of manufacturing and supporting processes,
– conducting investigations into deviations, proposing and conducting corrective and remedial actions,
– planning and conducting preventive actions,
– personnel training,
– ensuring the cleanliness and hygiene of the Manufacturing Plant,
– working in compliance with GMP, ISO guidelines.

The majority of new projects originate within the Development Department. It is here that we develop innovative solutions implemented to optimize the processes of mammalian and insect cell culture development, as well as the purification processes of obtained recombinant proteins. We are responsible for key activities related to the development, qualification, and transfer of quantitative and qualitative analysis methods, both necessary during the process development stage and for the characterization of the final product. We also conduct clinical studies from the planning stage to the analysis of pharmacokinetics, pharmacodynamics, and immunogenicity of drugs administered to patients.

Within the scope of the department’s work, we focus on the design and obtaining of expression systems, as well as the derivation of stable cell lines for the production of biological drugs, including biosimilars, and the development and optimization of protein purification methods.

We deal with the transfer and characterization of protein manufacturing processes. We replicate the manufacturing process on a laboratory scale to verify the impact of various factors on the final product quality, starting from cell culture and ending with product purification. We also actively participate in scaling up the manufacturing process.

In order to continuously and reliably monitor the progress of the conducted processes and the quality of the resulting products, even at early stages of development, we develop, qualify, and validate analytical biological and physicochemical methods. A wide range of analytical methods is also utilized for the characterization of protein products and in similarity studies for biosimilar molecules.

We ensure the highest quality of all the aforementioned activities through a team with extensive expertise and by consulting proposed solutions with EMA and FDA regulatory authorities.

Another distinguishing feature is our experienced team of clinical analysts, focusing on developing demanding and unique analytical methods. These allow us to characterize key drug parameters such as pharmacokinetics, pharmacodynamics or immunogenicity using innovative analytical techniques and equipment – all within GLP-certified laboratories.

We are also directly involved not only in verifying the workflow at clinical sites, but also actively participate in the entire process, which includes:

• Designing the clinical trial and consulting its strategy with the EMA/FDA,
• Creating the study protocol,
• Clinical trial start-up, overseeing and monitoring the work of clinical sites and CROs,
• Creating reports and closing the clinical trial,
• Preparation of the clinical part of the registration application to EMA/FDA for a medicinal product.

Working in the Quality Control Department provides you an opportunity to participate in a variety of projects. We work with modern equipment and a wide panel of various analytical methods, such as high-performance liquid chromatography, flow cytometry, mass spectrometry, capillary electrophoresis or real-time polymerase chain reaction (RT-PCR). We conduct in vitro cell cultures and biological activity tests. The primary tasks of the Quality Control Department include:

testing the biological and physicochemical properties of proteins produced at Mabion, quality verification of all raw materials used in the production process, testing the stability of products at all stages of production and determining their shelf life – verifying the microbial purity and/or sterility, development of quality documentation.

In addition, our team actively participates in the preparation of data needed for product registration and validation of analytical methods, as well as supports sterile processes such as product filling and simulation of the product filling process.

Our Quality Assurance Department maintains the developed standards at the highest level. It oversees the efficient and proper functioning of the company, which includes:

• optimizing operational procedures,
• defining procedures based on risk management,
• supervision of trainings,
• audits of material suppliers and contract manufacturers,
• internal audits,
• quality reviews of manufactured products,
• supervision of equipment qualification,
• process validation and subsequent verification,
• supervision of the change control system and verification of its effectiveness.

Due to the nature of our activities, we cooperate with all departments and take part in every stage of the drug development process: from early stages to distribution.

The Maintenance Department is responsible for maintaining the plant’s infrastructure and equipment in proper technical condition for safe operation. We are responsible for the availability of utilities, necessary for the operation of the plant, including clean utilities, manufacturing operations. We supervise the production of WFI water, provide electricity, heat, cold, and technical gases. We take care of an extensive HVAC system to ensure environmental conditions for rooms of different cleanliness classes, according to ISO standards and pharmacopoeial guidelines. There is also a qualification unit within the Maintenance Department. The unit works closely with the technical part of the maintenance department, and with every department within Mabion. It is responsible for maintaining the equipment of all departments in a qualified condition. It also supervises measuring and control equipment to ensure timely calibrations. The Maintenance Department works in compliance with the GMP system.

It is a department that combines competences from different areas of a business organization. Its interdisciplinary nature allows for broad support of many of Mabion’s activities, facilitating the execution of the Company’s projects. Administration Department specialists are responsible for the following issues:

• company information policy (PR/IR),
• hard and soft Human Resources (including employee development management and recruitment),
• EU projects,
• legal services,
• purchasing and procurement,
• management office,
• environmental protection and Integrated Management System,
• occupational health and safety,
• housekeeping.

The Administration team, with the support of substantive teams, participates in key scientific and business projects of the company, including international ones. It takes care not only of the company’s external image, but also of its internal environment, e.g. by organizing corporate social responsibility events or team building meetings. Working in this multidisciplinary team provides the opportunity to participate in many projects implemented by Mabion and guarantees rapid development of competences.

Our Finance Department combines accounting, financial controlling and treasury. In its daily work it provides information about the company’s activities, assets and financial situation, which is necessary, compliant with the law and gives a proper picture of the reality. It cooperates with all departments of the company and external advisors, as well as institutions, to which it periodically and continuously reports. Transparency and the highest standards are confirmed by annual reviews and audits carried out by independent audit firms belonging to the top ranked audit institutions. The Finance Department also ensures that economic events are reflected correctly and in accordance with regulations, which is the basis for analyses performed for current reporting needs and serves as the basis for extrapolations and short- and long-term forecasts. The department also performs a liquidity management function that allows for proper planning and settlement of ongoing projects or transactions taking into account the necessary sources of funding to be obtained.

The main task of Business Development (BD) department is to proactively search for the potential bio-tech industry partners, and subsequently manage cooperation with the contracted companies in a way that addresses their business needs and ensures that the offered services are properly adapted to the undertaken projects.

The BD department specializes in building the complex portfolio of CDMO services, which spans the entire process of biologic drug development and manufacturing (“end-to-end” CDMO). We constantly cooperate at the substantive level with Mabion’s operational and regulatory units in order to ensure the achievement of project goals and guarantee the compliance with applicable regulatory guidelines (EMA and FDA). Our individualized approach and focus on high quality of the delivered services allow us to obtain the best possible results and achieve full satisfaction of both sides with the established cooperation.

Our unit performs comprehensive market analyses and constantly monitors the emerging business trends to identify the current demand for contract services within the biopharmaceutical industry. Thanks to our regular participation in branch events such as BIO International, CPHI and Bio-Europe, as well as targeted marketing initiatives and proactive approach to clients, we constantly improve the brand recognition on international CDMO market.

The Business Development department is driven by the culture of innovation, and passion for building long-term relationships, making Mabion a trusted partner in every aspect of bio-tech drug development and manufacturing.

Working in the Regulatory Compliance and Advisory Division provides support to the Manufacturing and R&D departments in the execution of projects, through internal consultation, documentation evaluation and identification as well as participation in risk management. We support projects by identifying regulatory requirements at different phases of drug development, planning and supervising studies, as well as selecting the optimal regulatory pathway. We take care of the compliance of the Client’s documentation with regulatory requirements, as well as write registration dossiers.

We also provide support from external consultants and, if necessary, make inquiries to Regulators as part of advisory procedures.

Regulatory and Scientific Affairs Division, together with the Quality Control and Quality Assurance Department, implements Mabion’s quality policy for projects conducted for Clients. This is done through internal and external consultations and evaluation of quality documentation, among others. We identify regulatory context for a given Client’s biotechnological product, to ensure that documentation and processes carried out comply with regulatory requirements. We identify risks for projects, as well as try to find solutions. We support projects by identifying quality requirements at different phases of drug development, planning analytical and clinical studies, overseeing the analytical methods for use in quality control processes. We carry out operational activities within Scientific Advice procedures, clinical trial documentation as well as registration dossiers or post-approval changes.

We also participate in setting development directions on the basis of available scientific information.

The primary goal of the Supply and Logistics Division is to ensure that the right materials, products and services are available at the right time, in the right quantity and at the right cost to meet the operational needs of the organization and the demand of our customers. Our activities contribute to improved efficiency, cost savings and contractor satisfaction.
The efficient flow of materials, products and information throughout the supply chain consists of many activities that include:
– purchasing for operating departments,
– inventory management,
– warehousing,
– transportation and logistics,
– supplier relationship management,
– expense control,
– customs handling,
– fleet management,
– identification of process optimization.

The Project Management Office ensures effective execution of projects and defines standards and guidelines for their implementation. The tasks of the Office are interdisciplinary – during the process they combine the following responsibilities: business, legal and substantive, including among others:

• project implementation and optimization support at every stage,
• priority management based on schedules, including defining roles and responsibilities necessary in each project,
• participation in project methodologies and processes,
• supporting various stakeholder groups,
• distribution of information important in business areas,
• standardization of processes across departments,
• coherence of activities by developing a common language, culture and way of thinking about projects.

The most important role of the Project Management Office is to bring people, processes and tools together in a way which ensures project success. Our daily work is to implement and combine best practices and processes.