ACROBiosystems

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

Cygnus Technologies, part of Maravai LifeSciences, is the biopharmaceutical industry’s partner in host cell protein (HCP) and other process-related impurity detection and analytics. In addition, Cygnus now provides innovative viral clearance solutions as well.
Cygnus helps companies developing therapeutic proteins, vaccines, antibodies, plasma derivatives and gene therapies to ensure the safety of biotherapeutics prior to human trials, regulatory approval and commercial release. Cygnus provides analytical tools and solutions delivering insights to improve bioprocess development for faster regulatory approval and better clinical outcomes.
Cygnus is an industry pioneer responsible for developing and commercializing the first generic assay kits for HCP detection. Its reputation for quality is recognized by the industry and global regulatory agencies. It continues to advance the science of bioprocess impurity detection with new breakthroughs, including its Antibody Affinity Extraction™ (AAE) technology and orthogonal methods of HCP analysis that integrate Mass Spectrometry, AAE and ELISA. To reduce the cost and risk associated with viral clearance studies, Cygnus also offers a unique approach that utilizes non-infectious mock virus particles through its MockV™ virus clearance kits.
Cygnus’ proprietary technology, available through its off-the-shelf and custom analytics programs, sets the gold standard for enabling HCP and other bioprocess impurity antibody assays. Cygnus delivers best-in-class customer service and technical expertise, operational excellence and ISO-9001:2015 certified quality management systems.
Founded by Ken Hoffman in 1997, Cygnus continues to support and advance technology in order to improve biotherapeutic safety and accelerate the movement of new therapeutics through the development and regulatory approval process.
Located in Southport, North Carolina, Cygnus Technologies is online at www.cygnustechnologies.com.

Goodwin Biotechnology, Inc. (GBI), based near Fort Lauderdale, Florida, is a fully integrated, customer-focused cGMP Contract Manufacturing Organization (CMO) of Biosimilar and innovative monoclonal antibodies, recombinant proteins, vaccines, Antibody Drug Conjugates (ADCs) and other bioconjugates.

GBI offers a wide range of Single Source Solution services including cell line development, GMP master cell banking, proof-of-concept development, cell culture, purification and bioconjugation process development, scale-up, GLP pilot manufacturing for Tox animal studies, and cGMP manufacturing with fill & finish for human clinical trials.

These core services are complemented by full support relative to assay development and qualification, analytical and microbiological Quality Control (QC), as well as Quality Assurance and Regulatory Affairs (QA/RA). With over 20 years of experience as an independent contract development and manufacturing service provider, GBI has worked with organizations of all sizes from academic research institutions and virtual biotech start-ups to large, established multinational corporations.

HalioDx is an immuno-oncology diagnostic company providing oncologists and drug development organizations with first-in-class Immune-based diagnostic products and services to guide cancer care and contribute to precision medicine in the era of immuno-oncology and combination therapies.

Leveraging the pioneering work of Dr Jérôme Galon, HalioDx provides a unique range of immune scoring solutions including its flagship Immunoscore® assay for the assessment of the immune contexture of a tumor, as a key determinant of patients’ outcomes and response to cancer treatments.

HalioDx has developed a unique Biopharma partnering ecosystem for the identification of clinically relevant biomarker signatures, the demonstration of their clinical utility in trials and the development and commercialization of resulting diagnostic or companion diagnostic tests. Our programs draw on our expertise and focus on immuno-oncology, a complete suite of genomic and proteomic biomarker profiling services, a world-class data analysis and biostatistics platform, and CLIA-certified laboratories with compliant facilities in Europe and in the US to develop, manufacture, register and market in vitro diagnostic (IVD) products. HalioDx has rapidly become the preferred partner of Biopharma developing therapeutic antibodies, vaccines, chemotherapies, oncolytic peptides, and CAR-T cell therapies.

About Immunoscore®
Immunoscore® is an in vitro diagnostic test measuring the host immune response at the tumor site. It provides a robust, precise, quantitative, and consensus assessment of lymphocytic infiltration and has been shown to predict patient outcome and response to therapies in several indications.
Immunoscore® was included in the 2020 European Society of Medical Oncology (ESMO) Clinical Practice Guidelines for Diagnosis, Treatment and Follow-up for Localized Colon Cancer.
Immunoscore® is commercially available in more than 20 countries.

Intuitive Biosciences has been supporting biomedical research since 2012 by providing kits and services to monitor nonhuman primate health. In your lab our ours, our easy-to-use platform screens NHP blood samples for infectious diseases including tuberculosis and SARS-CoV-2. From routine SPF colony screening to antibody titer monitoring for vaccines, we can support your team and your research.

We offer: a full immunoassay platform available as turnkey system or OEM including consumables, content, SilverQuant detection reagents, analysis instruments and reporting software.

Join our email list for updates, specials, and new product launches! https://goo.gl/8kNszS