Biovian

Quality Assistance S.A. is a leading European Contract Research Organisation providing the pharmaceutical industry with all the analytical services required by EMA and FDA regulations for the development and marketing of innovative human medicinal products.

We assist our clients from candidate selection, through non-clinical and clinical studies, to marketing authorisation, using our state-of-the-art, product-dedicated expertise in analytical sciences.

For each customer and each project, we design customised solutions, define analytical protocols, develop and validate specific new analytical methods and perform characterisation, stability, pharmacokinetic, biomarker and immunogenicity studies as well as batch release testing, in order to evaluate the Quality, Safety and Efficacy of the given drugs.

Quality Assistance S.A. is an expert for the development of:
- Biologics (monoclonal antibodies, ADCs, proteins)
- New Chemical Entities, oligonucleotides, peptides
- Nanomedicine products
- Vaccines
- Cell-Based and Gene Therapy Medicinal Products

The company holds a unique position on the market with:
All its laboratories on one site (Donstiennes, Belgium)
- Bioanalysis (PK/TK/Immuno)
- Bioassays
- Biochemistry
- Chromatography
- Elemental Impurities
- Mass Spectrometry
- Microbiology
- Molecular Biology
- Protein Characterisation
200 highly qualified professionals
more than 35 years’ expertise at the forefront of analytical sciences.

Our core competencies are:
QUALITY (CMC)
- Development and validation of analytical methods
- Characterisation
- Stability studies
- Batch (release) testing
SAFETY/EFFICACY (Bioanalysis)
- Development and validation of bioanalytical methods
- PK/TK studies
- Immunogenicity studies
- Biomarker studies

The Quality Assistance environment is GMP, GLP and GCLP/GCP compliant.

Visit www.quality-assistance.com for more information

CEVEC is a leading provider of high-performance cell technology for the manufacturing of advanced bio-therapeutics from R&D to manufacturing scale. The company’s product portfolio comprises platform technologies for gene therapy viral vectors, vaccines and complex recombinant proteins.

With the ELEVECTA® Technology, CEVEC offers a unique solution for large-scale production of AAV vectors using helper virus-free producer cell lines with all necessary components stably integrated into the cell. The technology is based on suspension cells and does not require any expensive transfection reagents and cGMP plasmids.

CEVEC’s CAP® Technology based on human suspension cells is the ideal production platform for RCA-free Adenoviral vectors, Lentiviral vectors, viral vaccines and exosomes.

With the CAP-Go® Technology CEVEC provides a solution to the increasing need for recombinant production of complex and highly glycosylated protein molecules, including laminins, coagulation factors and plasma proteins.

As a Contract Research Organization specialized in formulation development of (bio)pharmaceuticals - including proteins, peptides, vaccines and virus-based ATMPs - Coriolis Pharma offers various services to support the development of your product:


Analytical method development
(aggregate and particle characterization, protein analytics, GMP analytics)

Formulation research and development
(from pre-formulation to market formulations)

Forced degradation and stability testing
(stress conditions tailored for the product, stability testing according ICH)

Lyophilization
(cycle development, scale up, modern PAT-tools)

Supply pre-clinical material
(GMP-like conditions in clean room)

EirGen Pharma, a subsidiary of OPKO Health Inc., was established in 2005 and employs over 200 people at two sites in Waterford, Ireland. Voted Irish Pharma company of the year (SME) in 2017 EirGen produces and supplies various pharmaceutical products globally, including those required for cancer treatment. OPKO is a publically traded healthcare company involved in the discovery, development, and commercialization of next-generation diagnostics, pharmaceuticals, and vaccines. EirGen Pharma R&D - an OPKO company, our Research & Development facility opened in June 2017.

IDT Biologika is a contract development and manufacturing organization with almost 100 years of experience in development and manufacture of live viral vaccines, gene and immune therapeutics, and fill/finish of biologics for the global protection of human health. With the expertise and capacity to handle large-scale campaign production of human vaccines and biopharmaceuticals, IDT Biologika brings development, testing and regulatory excellence along with state-of-the-art manufacturing lines required to advance projects with the highest level of quality, efficiency and consistency of supply.

Recognized for its technically sophisticated contract development, manufacture and handling of biopharmaceuticals in EMA- and FDA-inspected facilities, IDT Biologika has developed into one of the world's leading pharmaceutical and biotechnological companies.
The company's headquarters are located in Dessau-Rosslau , Germany. In the United States, IDT Biologika Corp. is responsible for sales activities throughout North America.