Anapharm Bioanalytics

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.

AGINKO Research is the premiere CRO for preclinical work in osteoarticular pathologies. We offer a wide range of contract research services to support Drug and Medical Device established companies as well as start-ups and academia. From industry standard protocols to customized research design, our animal models and assays, both on an in vivo or in vitro basis, provide key tools for compound discovery and product development.

Given our expertise, know-how, and network in the field of osteoarticular pathologies, AGINKO today also offers a full range of histology services for your preclinical and clinical trials as well as general consulting services (e.g., regulatory, strategy, financing) devoted to osteoarticular pathologies.


#Osteoarticular #CRO #Cartilage #Repair #Arthritis #Fracture #Osteoporosis #Preclinical #Pain #Disc #Spine #Infection

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

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.

We are proud to present the Biomex Network. Within the network, we are able to provide all necessary products and services that are needed to develop, validate, register and produce an IvD.
Biomex, founded in 1989, has over 25 years of experience in the delivery of human-based raw materials such as disease state plasma and patient samples. Over 95% of all delivered human materials are sourced in our donor centers in Heidelberg, Munich and Cameroon. In addition to the delivery of biological and clinical materials, Biomex also offers a spectrum of services, for example, assay validation or CE marking.

Medical Research Networx (MRN), our American affiliate, has an extensive network of Principal Investigators who perform biological sample collections of a broad range of patient popula- tions, including but not limited to infectious diseases, oncological, endocrinology, chronic diseases and normal. MRN’s network is capable of recruiting PI’s and providing administrative and regulatory assistance to develop protocol approved, client directed collections of any clinical population that are required from clients.

Biomex US is specialized in the production and delivery of an entire range of human serum from normal to flash frozen to AB male serum.

DiaMex, develops and produces plasma based manufacturer-independent multi-analyte serological controls. Aside from its own Optitrol portfolio, DiaMex also offers a wide range of tailor made serological controls.

ESfEQA, is an worldwide EQA program provider. Through the Biomex network, ESfEQA has the ability to supply an EQA scheme with samples that are most similar to patient samples.

Products
• Bulk plasma for production
• Residual patient samples
• Prospective sample collections
• Panels for R&D and QC
• Reagents for ELISA

We are proud to have a world-wide reach and to be the only company that covers all aspects of products and services needed for the R&D, QC and production of serological and NAT tests.