Manufacturing site
BIOTON’s manufacturing site in Macierzysz near Warsaw is one of the most modern biotechnological facilities in the world. This is where insulin is produced – both the active pharmaceutical ingredient and the finished medicinal form. BIOTON produces the highest quality insulin on a commercial scale, ensuring safe and effective diabetes treatment for patients.
BIOTON has two manufacturing facilities: Production Facility No. 1 where finished medicinal forms are made and our Biotechnology Facility where we produce the active pharmaceutical ingredient.
PRODUCTION CAPACITIES
Production processes
Preparing the biological material
Quality starts in bacteria cells
A state-of-the-art bacteria suspension filling system allows us to prepare up to 1000 cell bank vials in a very short time.
Before they are used for production, MCB and WCB cell banks are carefully inspected with advanced molecular biology techniques.
DNA sequencing and genotyping confirms that the vector and bacteria strain are compatible.
Biosynthesis
From one vial, through 7,000,000,000,000,000 bacteria in the fermenter, to pounds of Active Pharmaceutical Ingredient of the highest quality.
This sterile, high-efficiency continuous process takes tens of hours, but it ensures the perfect conditions for each cell to become a biotechnological factory and produce a live-saving molecule.
Isolation and purification
The modern processes of cell isolation, the formation of complex dimensional protein structures, enzyme transformation and advanced purification techniques allow us to achieve the highest-quality Active Pharmaceutical Ingredient (API).
Vacuum drying, packaging and labelling
The drying process takes place in deep vacuum and cryogenic temperatures by means of phase transition, i.e. the direct transformation from solid to gaseous state, which guarantees the optimum conditions for removing water from the process.
From preparation to the final process stage, all activities take place in aseptic conditions.
IPC – Process Control
Our team of experts oversees every stage of the production process, applying the most current methods compliant with global pharmaceutical standards.
The highest production standards are implemented through process planning, coordinating and controlling.
Drug formulation
Drug formulation (1500 dm3) takes place in a state-of-the-art and fully automated installation. The process meets the strictest GMP standards. For the production of insulin preparations we use, among others, insulin (the API produced at our Biotechnology Facility) and Bioton’s water for injections. The final stage of formulation is sterilizing filtration, the result of which are sterile solutions used for the final insulin preparation.
- Preparing raw material weighed amounts
- Preparing the drug formulation (1500 liters)
- Sterilizing filtration
Aseptic vial and cartridge filling process
The process of filling vials/cartridges with a sterile preparation is performed in a fully controlled environment, in isolated cleanrooms and clean zones that meet the strictest standards. It takes place on modern high-efficiency filling lines. All materials used in this process are sterilized. The filling is fully controlled and, after the dosing process, the product undergoes a 100% automated optical inspection.
Process stages:
- Preparing primary and secondary packaging materials
- Washing and depyrogenating vials and cartridges
- Sterilizing: primary packaging materials (caps, plungers), machine elements, cleanroom clothing, etc.
- Preparing cleanroom clothing
- Aseptic filling of vials with a sterile preparation
- Aseptic filling of cartridges with the insulin preparation
- In-Process Control (IPC) of vial/cartridge filling
- 100% automated optical inspection of filled cartridges
Packaging
Vial and cartridge packaging takes place on technologically advanced packaging line, automated to control the entire process. The packaging is adjusted to the needs of individual clients and the requirements of particular markets. In accordance with EU requirements , in February 2019 we successfully implemented a serialization system, which allows us to identify every individual package and secure it against tampering.
Process stages:
- Blister packaging of cartridges
- Individual box packaging
- Serialization
MEDIA
- Water for pharmaceutical use
- Clean steam
- Compressed air
Quality
Medicinal products
The strategic goal and priority of our activity is to ensure our patients’ safety by manufacturing the highest quality active pharmaceutical ingredient (recombinant human insulin), as well as effective, safe and durable medicinal products. All our products are manufactured in compliance with legal regulations and Good Manufacturing Practice standards. We hold regularly renewed GMP certificates issued by the Chief Pharmaceutical Inspector as well as foreign bodies. The certification covers all our production lines, QC processes and warehouses. Our products are manufactured and controlled in accordance with specifications and documentation that are the basis for issuing marketing authorizations for medicinal products. We have a quality assurance system in place and continuously perfect it, thus ensuring the highest quality of the products we manufacture.
Medical devices
With an aim to ensure the quality and safety of our medical devices, we have implemented a quality management system compliant with the EN-ISO 13485: 2016 standard, confirmed by a certificate issued by TUV Rheinland. The certificate is confirmed and renewed during annual audits.
Quality reports
Environment protection
Responsibility for the environment is a priority for BIOTON. Our activities comply with Polish law, and in our production, research and investments we always take into account the environmental aspect. Bioton’s experts actively participate in mastering their competencies and cooperate with academic centers on environmental initiatives.
Bioton S.A. strives to protect the environment by:
Raising the ecological awareness of its employees
Managing water and energy consumption in a sustainable manner
Supporting innovative, energy-efficient production solutions
Reducing the amount of waste
Encouraging “green” attitudes among its subcontractors