Database

Novasep Belgium

Solution provided
Technology
Supplier identity
General description

Created end of 1999 by the Professor Alex Bollen, the company Henogen, active in the field of biotechnology, was initially a spin-off from the University of Brussels (ULB). In 2009, Novasep acquired Henogen and integrated to the Novasep Biopharma Business unit.
The Biopharma Business unit supplies upstream and downstream contract manufacturing services to the biopharma industry.

Type of Supplier
Service Provider - CMO / CRO
Sector of activity
  • Biomanufacturing
  • Cancer / Oncology
  • Gene / Cell Therapy
  • Protein Therapeutics
  • Vaccines
Region
Region of Wallonia, BE
Regional access broker
  • Annick Pierrard, Interface Enterprises-University of Liège
Activity description
Terms of availability for SMEs

Novasep brings innovative solutions to complex challenges within the life science industries for the production of biomolecules. Our offering helps our customers to enhance product quality, reduce production costs and shorten time-to-market.
Novasep Belgium, located in the South of Brussels (Belgium), offers multiprocess and multiproduct (BL2 and BL3 for pathogen handling) clean rooms facilities for USP, DSP, formulation and fill & finish activities for products such as recombinant proteins, mAbs & conjugates, live bacterial vaccines, attenuated viruses, viral vectors for gene therapy, etc.
Novasep Belgium operates with numerous expression systems (bacteria, yeast, insect and mammalian cells, viral vectors) and several culture techniques (batch, fed batch, perfusion and microcarriers).
The multi product facilities that can bring new biomolecules from gene up to commercial stage.

Quality labels and accreditations

Novasep Belgium is regularly inspected by AFMPS (Agence Fédérale du Médicament et des Produits de Santé - Belgian Regulatory Authorities) following EMA requirements (European Medicines Agency).
Manufacturing authorisation of Investigational Medicinal Product according to Art. 13 of Directive 2001/20/EC: n°1535 IMP

Authorization N° FR-206: authorization to buy, store and use hormonal, anti-hormonal, anabolisant, Beta-adrenergic, anti-infectious, antiparasitary and anti inflammatory substances according to the Belgian legislation A.R. 12/04/1974 modified by A.R.

GMP Certificates n°: BE/2012/026 and BE/2012/027 (conformity of a manufacturer to GMP)

Training and Staff possibilities
No
Contact information
Name
Cécile
Surname
MAUPAS
Function
Area Sales Manager France, Benelux, Spain, Portugal and Italia
Phone number
+33 (0)6 12 78 03 32
Website Address
http://www.novasep.com
Address
Rue des Professeurs Jeener & Brachet 12
6041  GOSSELIES
Belgium