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Update your choices | BU : GMP BioManufacturing | Country : USA

Fill and Finish

cGMP Manufacturing

Fill & Finish

Our services include:
  • Formulation
  • Sterile filtration
  • Aseptic filling
  • Freeze-drying

in a class A (100) with B (1000) background area by trained and validated personnel and process. 

We seemlessly takes cGMP manufactured material on for formulation and F&F, in preparation for your clinical trials, using the expertise of long term preferred partners.

The Fill and Finish work is conducted under the Current Pharmaceutical Guidelines and the finished product is an injectable for human clinical trials.

All work associated with the Fill and Finish process conducted at the partner's site is controled by Eurogentec's Qualified Person (QP). The QP will review each manufacturing batch record for compliance with approved Process Documents.

We undertake the following:






Inspect facilities



Raw materials 

QC and release 



Preparation of clinical batch


 Sampling of Clinical Batch




 Perform in process testing (IPC)


 Quality assurance

 Environmental testing


 File batch record




Review and release batch record 


 Release / reject batch




 Maintain reject records




 Store released finished product


 Quality Control

 Operate bioburden programme for facilities and equipment




 Perform release testing on finished product




Kaneka Eurogentec S.A. Biologics Division
LIEGE Science Park
Rue du Bois Saint Jean, 14
4102 Seraing

Tel.: +32 4 372 74 00
Fax: +32 4 365 16 04

View Map | GPS: Latitude: 50.5932225 - Longitude: 5.5606055

Download our Eurogentec Biologics profile

Technical inquiries

Pascal Bolon, Ph.D.
Biologics Sales & Marketing Manager

GMP Biologics Information Request

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