The realization of our new production line is a special project, not only to us at BioConnection, but also because the enhanced capacity is a huge contribution to the thin worldwide production capacity of sterile drug products. Usually, strict restrictions are in place to enter these kind of sterile manufacturing lines. In the midst of the construction, we have a certain period available where all equipment is in and can be accessed with ease before the facility will be closed for all non-authorized persons.
This is why we offered a select group of Dutch press, representing around 8 scientific journals and newspapers, the chance to visit the new production line in our facility during a corona-proof ‘event’.
It was for them a unique opportunity to see a GMP pharmaceutical production facility from the inside and ask questions about the production process, the construction of such a production line, and the significance of the increased capacity for BioConnection, for The Netherlands and for the world.
We offered them a small tour along our new production line, where we showed them the process of washing, depyrogenisation, filling, freeze-drying, and capping of sterile drug products.
From October onwards the production area will be closed for all non-authorized persons. It is then subject to extensive testing and validation programs, training of operators and the performance of various Media Fill runs. Once all tests and validations are complete, the new production line will only be accessible to authorized personnel in sterile clothing.
Despite the worldwide challenges we face due to the coronavirus pandemic, the planning of the construction of our new production line is spot-on-track and we anticipate to produce the first GMP batches for our clients as of April 2021.