Fill & Finish

Wacker Biotech has over 20 years of experience with aseptic filling and lyophilization of a broad range of biopharmaceuticals. The fill & finish suite in Amsterdam can be used for filling of your bulk drug substance produced at Wacker Biotech, but also as stand-alone service offering. The processes used at Wacker Biotech for the manufacturing of our client drug product batches comply with EMA standards and FDA guidelines.

GMP Manufacturing

The aseptic fill & finish manufacturing in one of the most critical parts of manufacturing biopharmaceuticals. It includes formulation of bulk drug substance, sterilization, filling, stoppering, capping and visual inspection. Wacker Biotech is able to liquid fill in 2R to 20R vials and lyophlize up to 20,000 vials per batch or perform bulk lyophilization of up to 65 liter bulk drug substance.

Our aseptic filling suite consists of a formulation/preparation area as well as the principle filling area which contains a Flexicon FMB210L Monobloc semi-automated filling machine (filling, stoppering and capping) and Edwards freeze drier (6 m2). Depending on vial size (DIN 2R to 20R), batch sizes up to 20,000 vials per batch can be filled.

Wacker Biotech has experience in formulation and lyophilization development and are ready to collaborate with you on the development of your biopharmaceutical drug product. Wacker Biotech has bench scale equipment to run small-scale processes, to match the large-scale fill & finish equipment in our facility. For the fill & finish suite, Biosafety Level 1 (BSL-1) is applicable.

Experience Aseptic Liquid Filling:

  • Monoclonal antibodies
  • Recombinant proteins
  • Alum-containing vaccines
  • RNA/DNA
  • Allergy vaccines
  • Live Microbial Products (LMP)
  • Diluents and placebo

Experience Lyophilization (Bulk or Vials):

  • Recombinant proteins
  • RNA/DNA
  • Allergy vaccines
  • Live Microbial Products (LMP)

LOCATION SELECTION

Please select your location so that we can provide you with optimal product recommendations.