BIOTON is one of the 8 global commercial manufacturers of recombinant human insulin. What does this mean in practice? What does our production process look like?
Where is the insulin manufactured?
The factory is located in the town of Macierzysz near Warsaw and it is one of the most modern biotechnological operations in the world. Both the active substance and the ready-made forms of the drug are produced here: The Drug Product Production Plant deals with the production of medicinal preparations and the Biotechnology Plant produces the active substance.
The active substance (API – Active Pharmaceutical Ingredient) manufacturing process is divided into 4 stages:
Preparation of biological material:
At this stage, we use a cutting-edge system for bottling bacterial suspensions. As a result, we can prepare up to 1,000 vials for our cell bank in a short time. These are checked using sophisticated molecular biology methods before being released for production. DNA sequencing and genotyping confirm the compatibility of the vector and the bacterial strain.
This is a sterile and highly dynamic fermentation process that takes several hours. It provides the ideal conditions for each cell to become a “biotechnology factory – host” producing a life-saving molecule.
Isolation and purification:
This step consists of state-of-the-art processes of cell isolation, formation of complex protein spatial structures, enzymatic transformation and purification techniques that produce top-quality active substance.
Vacuum drying, packaging and labelling:
Drying is carried out in a vacuum environment and under cryogenic conditions using phase transformation – a direct transition from solid to gas. This guarantees exact moisture removal from the process.
IPC – process control:
At each stage of the manufacturing process, a team of specialists looks after and monitors the quality of the manufactured product using modern methods in line with global pharmaceutical standards.
Drug Product manufacturing
The next step in insulin production is to use the manufactured active substance to formulate the finished product. We can divide it into 3 stages:
The preparation of insulin formulations uses insulin – the active ingredient and injection water from the company’s own facilities. The final stage is sterile filtration, resulting in sterile solutions which are then used to make the final insulin preparation.
Aseptic filling– vials and cartridges:
This process occurs under controlled conditions, in a separate high-purity zones, on state-of-the-art high-efficiency filling lines. All materials used during this process are sterilised. The filling process is taking place in a controlled and monitored environment . Once filling completes, the product undergoes 100% automatic optical control.
Vials and cartridges are packaged on modern packaging lines, equipped with automatic systems to make sure packaging is correct. Packaging is tailored to individual customer expectations and market requirements. From February 2019 in line with the EU Directive, a serialisation process has been effectively implemented in order to allow each unit pack to be identifiable and tamper protected.
In line with GMP requirements our top priority is to ensure patient safety by manufacturing the active substance – recombinant human insulin – of the highest quality, as well as effective, safe and durable medicinal products. Therefore, our products are manufactured and controlled in accordance with the specifications and documentation on which official approvals are based. The high quality of the products is ensured by an implemented and continuously improved quality assurance system.