Blood Assay Solutions

Anapharm Bioanalytics is a customer-focused bioanalytical CRO specialized in small and large molecule bioanalysis. Led by a team with over 30 years’ experience in method development, validation and sample analysis, we support drug development programs for the pharmaceutical, biotechnological and generic industries worldwide.

Equipped with state-of-the-art LC-MS/MS and LBA technology platforms, Anapharm Bioanalytics provides an array of services including PK studies, biomarker testing and immunogenicity assays throughout preclinical and clinical stages. Our global network of partners allows us to provide full-service outsourcing solutions to conduct preclinical, Phase I-IV clinical trials, and bioequivalence studies for international registration.

Our clients benefit from a deep scientific expertise combined with a robust quality system. All our activities are compliant with GLP and GCP, having undergone 20 regulatory inspections by the FDA, several EU Health Authorities and ANVISA (Brazil).

Whether your drug candidate is a new chemical entity, a new biologic, a generic or a biosimilar, do not hesitate to contact us at info@anapharmbioanalytics.com.

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

GEM FORLAB gives continuity to the experience of ABLE Biosciences as a global provider of scientific technology and services to the Life Science industry. It delivers solutions to companies of all size and shapes.
GEM FORLAB performs its activities by means of three technology areas:
Organic Chemistry
Mass Spectrometry & Proteomics
Cell and Molecular Biology & Immunoassay

ABLE Biosciences is the Test Facility GLP certified for small and large molecules quantitative analysis in biological matrices by means of Mass Spectrometry, Immunometric assays and qPCR and it is included in OsSC register of Private Laboratories qualified to perform analysis on samples derived from drug clinical trials (phase I-II-III) in compliance with GCP.

The Chemistry Unit provides all essential components for early drug discovery such as synthesis of chemical intermediates, process impurities, reference compounds, drug metabolites, and pro-drug; lead generation and optimization; bioconjugate chemistry; targeted molecules for MRI and others Molecular Imaging techniques.

ABS Laboratories is a MHRA, GLP and GCP accredited contract research organisation. We specialise in the quantification of drugs, metabolites and biomarkers in biological fluids using LC-MS/MS, GC-MS, LC-UV and multiplexed biomarker assays.

Our bioanalytical staff are experts in developing, validating and applying sophisticated analytical techniques to achieve the desired out comes all within the regulatory frame work.

ABS prides its self on the quality of its customer service and rapid turn around times. Our skills and state of the art equipment enable us to support a wide range of studies small and large.

We have a wealth of experience supporting Pharmaceutical R&D, Universities and Charitable Organisations from in-vitro research through to preclinical and clinical studies to final MAA/NDA submission. We are also proud to work with the NHS supporting clinical diagnosis, screening and therapeutic drug monitoring.

ABS also owns a large library of validated bioanalytical methods for multiple drugs so is pleased to offer very rapid initialisation and analysis of study samples.

Addex Therapeutics is a clinical-stage pharmaceutical company focused on the development and commercialization of an emerging class of novel orally available small molecule drugs known as allosteric modulators for neurological disorders. Allosteric modulators offer several potential advantages over conventional non-allosteric molecules and may offer an improved therapeutic approach to conventional "orthosteric" small molecule or biological drugs. Addex's allosteric modulator drug discovery platform targets receptors and other proteins that are recognized as essential for therapeutic intervention. Addex's lead drug candidate, dipraglurant (mGlu5 negative allosteric modulator or NAM), is poised to start a pivotal registration clinical trial for Parkinson’s disease levodopa induced dyskinesia (PD-LID) in H1 2021. Addex is also investigating dipraglurant's therapeutic use in blepharospasm (a type of dystonia), for which a clinical trial is expected to be initiated in H1 2021. Addex's third clinical program, ADX71149 (mGlu2 positive allosteric modulator or PAM), developed in collaboration with Janssen Pharmaceuticals, Inc., is scheduled to enter a phase 2a proof of concept clinical study for the treatment of epilepsy in H1 2021. Addex’s GABAB PAM program has been licensed to Indivior PLC for the treatment of addiction. Preclinical programs include GABAB PAM for CMT1A, mGlu7 NAM for PTSD, mGlu2 NAM for mild neurocognitive disorders, mGlu4 PAM for Parkinson’s disease and mGlu3 PAM for neurodegenerative disorders. Addex is listed on the SIX Swiss Exchange and NASDAQ Capital Market, and trades under the ticker symbol "ADXN".