Cell Guidance Systems

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

Synteract®, a Syneos Health® company, is a leading full service CRO focused on the emerging biopharma segment. The Company’s multidisciplinary teams support biotech and pharmaceutical companies across all phases of drug development, providing deep expertise in oncology, dermatology, general medicine, infectious disease and vaccines, neuroscience, pediatrics, and rare and orphan diseases. Synteract has conducted nearly 4,000 studies on six continents in over 62 countries.

Avitide discovers, develops, manufactures and supplies custom and catalog biopharmaceutical affinity purification solutions to the biopharmaceutical industry. Avitide’s proprietary AVIPure™ affinity ligand portfolio sets the standard for precise affinity separations and consistent robust performance for its high-valued chromatographic products. Avitide develops these technologies with an industry-leading 3-month, concept to resin delivery service timeline that enables industry biopharmaceutical manufacturers and contract developers to achieve faster bioprocess development timelines, improved process economics, predictable scalability, and enable next-generation integrated continuous downstream processing. Avitide’s commercial resin manufacturing and supply operates under an ISO 9001:2015 quality management system and has been successfully audited for its quality systems and continuity of supply plan for its affinity chromatography products. Avitide has successfully deployed affinity purification technologies towards an array of biological molecules including enzymes, bispecific antibodies, therapeutic scaffolds, growth factors, hormones, insulins, blood factors, Fcfusions, cell-based therapies, vaccines, and gene therapy viral vectors. Avitide's management team brings substantial industry expertise and a successful track record in commercializing innovative biopharmaceutical manufacturing platforms. Avitide is financed by premier venture capital and private equity firms, including Polaris Venture Partners, OrbiMed Advisors, Mithril Capital Management, Sands
Capital Ventures, Section 32, SV Health Investors, Borealis Ventures, and NeoMed Management. For more information, visit www.avitide.com.

Bavarian Nordic is a fully integrated vaccines company focused on the development, manufacturing and commercialization of life-saving vaccines. We are a global leader in smallpox vaccines and have been a long-term supplier to the U.S. Government of a non-replicating smallpox vaccine, which has been approved by the FDA, also for the protection against monkeypox. The vaccine is approved as a smallpox vaccine in Europe and Canada. Our commercial product portfolio furthermore contains market-leading vaccines against rabies and tick-borne encephalitis. Using our live virus vaccine platform technology, MVA-BN®, we have created a diverse portfolio of proprietary and partnered product candidates designed to save and improve lives by unlocking the power of the immune system, including an Ebola vaccine, which is licensed to the Janssen Pharmaceutical Companies of Johnson & Johnson. We are also committed to the development of a next generation COVID-19 vaccine.

For over 30 years, Bionique Testing Laboratories has been a trusted partner and global leader of Mycoplasma Testing Services for the life science industry. And what is mycoplasma? It's a drug-resistant bacteria that can infect different parts of your body.

Bionique offers the full breadth of GMP services from Lot & Final Drug Product Release Testing to Real-Time PCR assays. Our service portfolio and depth of expertise enables us to support our clients’ needs from concept through clinical trials to commercialization for biopharmaceutical and cell therapy products. Our capabilities extend to successful method development and validation inclusive of rapid microbiological methods to generate real time results. Bionique stands ready to provide the highest quality of mycoplasma testing services to ensure the integrity and biosafety of your therapeutic products.

Mycoplasma Testing Solutions for:
• Cell and Gene Therapy Products
• Clinical Trial Materials
• Biopharmaceuticals
• Master and Working Cell Banks
• Raw Materials
• Vaccines

Bionique is a cGMP compliant, FDA-registered facility.