BioConnection gets GMP certification and manufacturing license for new large scale filling line of sterile drug products for medicinal use in humans
BioConnection, 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 granted GMP Certification by the Dutch Healthcare and Youth Inspectorate (IGJ) for the production of sterile drug products on their new large scale filling line.
The granting of this production license means that BioConnection now can produce sterile medicines in their facility for its customers on a much larger scale than before. The company is now also well positioned to fill a gap in the worldwide shortage in fill & finish production capacity for, amongst others, vaccines.
In April 2019, BioConnection announced its plans to invest 12 million euros in a new production line including a 10 m² freeze drier 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 is now 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.