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

Large scale filling line

Large scale filling line

Automated filling line in “tunnel” design

Filling line (Groninger)
  • Vial washing machine
in grade D cleanroom
  • Depyrogenisation oven
in grade D cleanroom
  • 4 needle Filling machine
    (incl 100% IPC + stoppering)
grade A open RABS in grade B cleanroom
  • Capping machine
grade A open RABS in grade D cleanroom
Lyophilizer (HOF) grade A open RABS in grade B cleanroom
  • 10.2 m²
  • Automated loading/ unloading
  • 7 shelves
  • Liquids: up to 500L + / batch
  • Freeze dried: up to 200L/ batch
  • Up to 40 million vials/ year (2 RDIN, liquid)
  • Up to 4 million vials/ year (2 RDIN, freeze dried)
  • Speed (default): 11.520 vials/ hr (2 RDIN)
  • Vial sizes: 2 RDIN up to 50 RDIN vials

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

EMA and US-FDA certified facility

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