Oss, The Netherlands, June 28, 2021.
BioConnection received today from the Dutch Healthcare Inspectorate (IGJ) the GMP certification and manufacturing license for their new large scale filling line
BioConnection B.V., an independent CMO (Contract Manufacturing Organization) based in Oss, The Netherlands, specialized in the production of sterile drug products for medicinal use in humans, has been given permission from the Dutch Healthcare and Youth Inspectorate (IGJ) to produce sterile drug products on their new large scale filling line. The receipt of this manufacturing license landmarks the go-ahead for BioConnection and their customers to now produce sterile drug products on a larger scale in their facility. The company is now also in a good position to fill a gap in the worldwide shortage of fill & finish production capacity for vaccines, for example.
In April 2019, BioConnection announced its plans to invest 12 million euros in a new production line to significantly increase its production capacity and to ensure future company growth. Construction started in December 2019. The construction was spot-on-track and within 18 months, the new line now is approved and licensed for GMP productions.
EMA and US-FDA requirements
The new production line has an annual production capacity of up to 40 million vials for liquid products and up to 4 million vials for freeze-dried products. It features a fully automated filling line (by Groninger, Germany) coupled to a fully automated 10 m2 freeze dryer (by HOF, Germany). The new production line is built to meet the highest quality requirements in the (bio) pharmaceutical industry which enabled BioConnection to have the line validated as per the EMA and US-FDA quality guidelines.
Due to the expansion, BioConnection is now able to service its clients from four different production lines within one facility in production scales ranging from 0,1L to 1.000L per batch.
“We are extremely proud of our new large-scale filling line and its significance for the Dutch pharmaceutical manufacturing industry. We can make an important contribution to fill a gap in the worldwide shortage of production capacity for sterile medicines”, says Alexander Willemse, CEO at BioConnection.
You can read here about the specifications and capabilities of our new large-scale filling line.
You can read the history of the construction of our new production line in this archive.
About BioConnection B.V.
BioConnection (founded in 2005) is an independent CMO (Contract Manufacturing Organization) for the GMP production of sterile drug products in vials or syringes for either clinical trial programs or commercial purposes. We have a worldwide customer base and a great deal of expertise and knowledge in the area of sterile productions. Our state-of-the-art GMP facility is EMA and US-FDA certified. Besides Fill & Finish including freeze drying we offer complete drug product service packages including: technology transfer, scale-up, lyo-cycle development, process validation, analytical support, stability studies, label & pack (including serialization) and final GMP release to clinic or market.