Bioconnection: GMP certification for new large scale filling line

BioConnection received 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.

#100YEARSPHARMAFUTURE

The development of medicines in Oss began one hundred years ago. It was then that the foundations were laid for what would become a flourishing pharmaceutical sector in the Netherlands, leading to groundbreaking discoveries such as insulin and the anti-conception pill.

Today, the entire chain is still represented in Oss, from early-stage research to the commercial scale production of medicines. Working in Oss, we focus on the health of people all over the world. Employees at dozens of companies large and small put their heart and soul into new medicines, products and services that will improve lives worldwide. Together, our strength lies in our combination of broad knowledge about the development of medicines and a thorough understanding of the requirements of high-quality production.

This shared past and common values stimulate strong bonds among everyone who works in pharmaceuticals in Oss. We build on qualities, expertise and networks that go back decades. And with a wide variety of pharmaceutical companies, suppliers and scientific institutions all located nearby, we offer an attractive business climate and an excellent basis for international collaboration.

We are proud to work together to create a better and healthier future for all, a collaboration that in turn fuels growing employment: today, most pharmaceutical jobs in the Netherlands are in Oss. Here we connect talent and companies and stimulate entrepreneurship, while our expert employees are our most important asset. Their drive ensures that Oss has an influence on health all over the world.

Pharma in Oss offers endless opportunities to startups and talent in a city and region that is a joy to live and work in. We are committed to collaboration and sustainable and successful entrepreneurship. Oss’s pharmaceutical companies are intrinsically competitive while also being committed to quality and safety. This, plus their focus on new health solutions and contemporary technology, makes us a leader in our pursuit of a better life for people worldwide.