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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:

Area

Event

Eurogentec

Partner

Initiate

Inspect facilities

 √

 

Raw materials 

QC and release 

 

 Manufacture

Preparation of clinical batch



 

 Sampling of Clinical Batch

 √

 √

 

 Perform in process testing (IPC)


 √

 Quality assurance

 Environmental testing



 

 File batch record

 

 √

 Release

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

 √

 

Office

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

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

info.biologics@eurogentec.com

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Download our Eurogentec Biologics profile

Technical inquiries

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

GMP Biologics Information Request

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