Covid update

Commercial fill and finish

BioConnection offers commercial fill and finish for your products. Our capabilities include liquid fill or lyophilization intended for vials or prefilled syringes. Our large scale state-of-the-art fill and finish line enables you to scale up to commercial production in time for the market.

Commercial scale fill and finish

The large scale filling line has an annual production capacity of up to 40 million vials for liquid products and up to four 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). This 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.

With our offer in both clinical scale and commercial scale fill and finish, BioConnection is able to service its clients from four different production lines within one facility in production scales ranging from 0,1L to 500L+ per batch.

Large-scale filling line + 10 m² freeze dryer

Compounding volumes: up to 500L+

Indicative maximum batch sizes (*)

Vial size Liquid product Freeze dried product
2 RDIN 57,000 – 150,000 44,900
6 RDIN 57,000 – 150,000 23,200
10 RDIN 50,000 – 150,000 19,600
20 RDIN 25,000 – 100,000 12,600
25 RDIN 20,000 – 80,000 12,600
50 RDIN 10,000 – 40,000 6,800

(*) Actual batch size depends on requested scale of production and filling volume/vial. Examples are based on a 50% filling volume/vial (e.g. 25 ml fill in a 50 RDIN vial, etc.)

Summary of our services

Drug product development

  • Formulation development
  • Process and analytical development & validation
  • Lyo-cycle development and/or optimization
  • Transfer and scale-up to clinic
  • Transfer and scale-up to market

Freeze drying

  • Shelf areas ranging from 3 m² up to 10 m²

Clinical trial material services

  • Labeling
  • Clinical trial packaging
  • QP release
  • Storage

Fill and Finish

  • Batch sizes: from 1 unit up to 150,000 units per batch
  • Clinical and commercial scale
  • Automated fill and hand fill
  • Aseptic filling
  • Vials: from 2 RDIN up to 50 RDIN
  • Syringes: from 0.5 ml up to 10 ml
  • Other primary packs: via handfill
  • Terminal sterilization
bioconnection

Covid-19 update BioConnection

BioConnection has taken precautions related to the global outbreak of the Covid-19 virus. To start with; we are currently in full operation and running on-schedule with regard to our planned productions. Our production department is on full strength and we have no shortages of material(s) nor do we foresee them.

For our personnel we are following the guidelines as issued by the Dutch National Institute for Public Health and the Environment, RIVM (www.rivm.nl). This means that people stay at home when they show (early) symptoms connected to Covid-19. Furthermore BioConnection employees work from home as much as possible. We avoid shaking hands and keep distance from each other. We take every precaution as advised to prevent the spread of the Covid-19 virus and will fully comply to the requests as stated and/or enforced by the authorities.

Our expansion project (expansion.bioconnection.eu) is running as planned to start GMP production in Q2 2021. We stay in close contact with our suppliers for the production equipment.

We review for Covid policy changes by the authorities on a daily base and adapt to them. If changes occur, this statement will be updated accordingly so you always have the latest information. In case you have any questions, please do not hesitate to contact us via our general number or website. Current customers of BioConnection, can contact their dedicated program manager. In case you want BioConnection to become a partner in your development or manufacturing, please contact our Business Development department via contact@bioconnection.eu.

The BioConnection Management Team.

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