Aptum Biologics Ltd.

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

Draconis Pharma is a company mainly focused on the research of immunological response and the new therapies for the treatment of immune-based diseases such as inflammation, autoimmunity, allergy and related diseases (cancer, pain, etc).
Draconis offers experimental services in the early stages of discovery and pre-clinical research to pharmaceutical, biotechnological and food companies. Draconis’ scientific expertise guarantees highly customized solutions to evaluate, the efficacy, safety and toxicology of many types of compounds, such as small molecules, proteins, antibodies, RNA-based compounds, vaccines, functional foods or probiotics, in a wide range of target and disease experimental models.
Draconis has developed an own pipeline as a result of its R&D collaborations.

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.

Ludger is a bioscience company specialising in technology for the measurement and control of biopharmaceutical glycosylation. We are ISO9001 accredited. Our technology is used in the quality control of FDA- and EMEA-approved biopharmaceuticals worldwide, and can be used to support IND submissions. Clients include leading pharmaceutical and biotechnology companies throughout the world.

Ludger manufactures a comprehensive range of kits and reagents for ICH-compliant glycoprofiling of biopharmaceuticals throughout the drug development cycle. Our catalogue includes kits for glycan release, labelling and purification. We also sell labelled glycans, glycan HPLC columns, endoglycosidases and glycoprotein standards. Ludger is committed to ongoing new product development to ensure that there are high quality products available to you.

Established in 1999 we have a wealth of experience providing structural glycan characterisation of innovator and biosimilar biotherapeutics, including:

Monoclonal antibodies (mAbs)
Hormones e.g erythropoeitin (EPO)
Fc fusion proteins
Plant glycoproteins
Viral glycoproteins
Parasitic glycoproteins
Vaccines
Clotting factors

This will help you address safety, efficacy, product consistency, stability and half-life, regulatory compliance, patent issues and comparability of your drugs. Analytical methods used in house include (U)HPLC, ESI-MS, MALDI-MS, LC-MS. In addition we can work to Good Manufacturing Practice (GMP) level services for our clients

Mabion Poland S.A. is a leading biotechnology company that was created in order to market the latest generation of biotech drugs based on humanized monoclonal antibodies.

This technology, developed in Mabion by itself, is a high-tech at the highest level. The process of humanizing monoclonal antibodies, being the apex of today’s biotechnology enables the production of targeted drugs that act selectively on cancer cells, providing greater efficacy and lower toxicity of the therapy.

Mabion was created in March 2007 by four national pharmaceutical companies: Celon Pharma Łomianki, one of the leading cancer drugs in Poland, Polfarmex from Kutno, which is a national leader in the market of prescription medicines, IBSS Biomed from Krakow, Poland’s largest and counting the European manufacturer of vaccines and Genexo from Warsaw operating in the market of drugs and medical devices, mainly in the field of diabetes. Mabion also created two entities carrying out research in the field of biotechnology: BioCentrum and Biotech Consulting.

Within a few years Mabion competence possessed the manufacture of any biotechnological drugs from the design phase through the choice of platform and manufacturing technologies to produce the finished drug. Currently in its laboratories in Łódź, the company conducts research and development on a number of biotech drugs, used in the treatment of cancer and metabolic diseases.