Biosimilar’s manufacturing process

5/24/2016

How is a biosimilar manufactured?
 
Along the lines of the previous post, in which we explained the steps leading to the development of a biosimilar, the aim of this post is to outline the manufacturing process, by means of a video showing some of the phases.
 
The manufacturing phase entails, on one hand, the so-called API process. To give you a clearer idea of this procedure, we leave you with these images taken in the facilities of our production development plant in Buenos Aires, the first in Latin America devoted to monoclonal antibodies.
 

 
As the video shows, biosimilars are manufactured by means of a complex process that can be broken down into seven phases:
 
1. Preparation of the material.
2. Preparation of fluids.
3. Cellular expansion, which is essentially the cultivation of cells for producing the biosimilar.
4. Harvesting.
5. Purification process.
6. Packaging.
7. Quality control procedure, subject to auditing by the national regulatory authorities.
 
After the API process, and in order to obtain the final product, we need to perform what is known as “Fill & Finish”.
 
 
What exactly is Single-Use technology?
 
As a crucial feature, we would like to highlight another of mAbxience’s key characteristics for the development of biosimilars. It’s our Single-Use technology, which we employ in our other Spanish plant in León.
 
It entails the use of disposable bioreactors, the advantages of which are twofold: on the one hand, it allows greater flexibility, allowing product changes in record time; on the other, it removes any possibility of cross-contamination throughout this process.
 
Furthermore, using this technology significantly reduces the consumption of resources during the production processes. Water consumption is cut by 80%, and the use of cleansing agents by 90%, thereby decreasing the environmental impact of our facilities.
 
In short, this, along with other factors characteristic of our manufacturing process, is conducive to obtaining biosimilars with the highest standards of quality.