AEIRTEC LTD

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.

Accelerō® Bioanalytics GmbH is a certified GLP test facility, and operates in compliance with ICH GCP regulations. Competent authorities approved Accelero´s Biosafety Level S2 laboratories for both microbiology and genetic engineering.

Accelero is proud to serve our clients with:

• OECD GLP approved facilities for analytical, non-clinical studies.
• ICH E6 R1 GCP compliant analytical facility for clinical phase 0 to 3 studies.
• Facility approved for handling and cultivation of BSL-2 micro-organisms (bacteria, yeasts).
• Facility approved for genetic engineering / cloning / analysis of safety level S2 GMOs
(bacteria, yeasts, viruses, plants, animals).
• Approval for the import and analysis of animal by-products from non-EU countries (e.g. like U.S.A., China).

Accelero services include, but are not limited to:

• Pharmacokinetic / toxicokinetic characterization (ELISA, qPCR, immuno qPCR).
• Biodistribution and shedding (qPCR).
• Biomarker screening on the RNA level (qPCR, microarray) and the protein level (microarray).
• Cell-based in vitro immunoassays (ELISA, EliSpot, flow cytometry).
• Particle-based multiplex immunoassays (flow cytometry).
• Particle-based multiplex miRNA (microRNA) assays (flow cytometry).
• Cell proliferation and cytotoxicity assays (flow cytometry, EliSpot).
• Gene expression assays (RTqPCR).
• GLP training services (basic courses, in-house trainings).
• Antibody detection assays (ADA): screening, confirmatory, neutralization (EliSPOT).
• Preclinical consulting services with regards to GLP and bioanalysis.
• Complement activation monitoring.
• Supply chain services e.g. like sample transport and shipping organisation, preparation of clinical kits.

All analytical methods are developed and validated according to the respective EMA, FDA, and/or ICH guidelines.

Accelero® is a trademark fully owned by Accelero Bioanalytics GmbH, Berlin (Germany).

Last update of this page: 31-DEC-2017 by CL

Within Basel neighbourhood and at the very heart of Europe (the triple border of France, Germany and Switzerland), Firalis is a pioneering biotechnology company, active in discovery, development and qualification of biomarkers (BM).

1) BIOMARKER PRODUCTS
Firalis develops BM-based diagnostic, prognostic and theranostic tools:
● RUO Kits (Research-Use-Only), based on validated innovative biomarkers
● IVD Tools (In Vitro Diagnostic), based on a combination of clinically qualified biomarkers

2) BIOMARKER R&D
● Development of proprietary BMs
- Cardiovascular, Inflammatory, Autoimmune and Neurology
● Drug Safety & Drug Efficacy
● Patient Stratification
● Personalized Medicine

3) BIOMARKER-RELATED CRO SERVICES
BM Discovery for laboratories, biotechs and pharmaceutical industry:
- Proteomics: Soluble biomarker measurements with several immunoassays technologies (ELISA, multiplex and high sensitivity platforms such as Luminex® BioPlex 200™, Meso Scale Discovery®, Singulex Erenna®, Protein Simple Ella™, Olink and Siemens Dimension® EXL™ 200)
- Genomics/Transcriptomics: Targeted sequencing of miRNA and mRNA (HTG EdgeSeq), lncRNA screening via Firalis proprietary platform, Next-Generation Sequencing (NGS) services (RNA-Seq, whole genome and exome sequencing, etc.) and qPCR/microfluidic qPCR (Gene Expression, SNP, CNV, etc.)
- Flow Cytometry: Immunophenotyping of preclinical and clinical samples, monitoring of pharmacodynamics on target cells in response to treatment and biomarker discovery
- Assay development and validation on various platforms, development of critical reagents (antibodies and proteins)
- Biobanking and sample repository services supported by LIMS
- Data analysis using multi-parametric statistics and development of predictive models
- Support of regulatory activities related to biomarker qualification with Health Authorities (FDA/EMA)
- Quality environment (ISO 9001, ISO 13485 (GMP), ISO 17025 (GLP/GCLP))

For more information please visit our website.

Glycotope, founded in Berlin in 2000, is a clinical stage immuno-oncology company built on world-leading glycobiology expertise.
A set of our highly innovative clinical and pre-clinical projects with focus on oncology/immuno-oncology are available for partnering.
The Company has a mature and growing pipeline of proprietary cancer therapies. Our innovative GlycoExpress® technology enables the generation of high quality oncology and non-oncology candidates with fully human glycosylation improving activity, drug characteristics and side effect profiles. The GlycoBody platform generates highly specific mAbs against carbohydrate epitopes found only on tumor cells.

In addition, our capabilities in early-stage research and development provide a wide range of services for biopharmaceutical companies incl. glycan analytics (N- and O-glycans) as well as a whole range of protein analytics, USP and DSP process development, assay development in immune oncology as well as clinical immunomonitoring (http://www.glycotope.com/biopharmaceuticals-services/).

ScreenCell was set-up with the belief that just enumerating Circulating Tumor Cells (CTCs) without easily characterizing them was not enough to allow the early detection of a disease and to potentially follow-up the cancer progression. So it designed and produced a simple but revolutionary technology allowing the fast and effective isolation of CTCs for a better cellular and molecular characterization, which is essential in cancer monitoring. This technology also contributes to the development of a new non-invasive approach to prenatal diagnosis.

Screencell is dedicated to create technologies allowing CTC to become potential end points in future oncology therapeutic arsenals, by filtering out healthy live tumor cells, thus enabling:
• Molecular biology
• Cell culture
• Enumeration and cytomorphology evaluation

For that matter, ScreenCell has designed a full range of devices (marked CE) compatible with existing In vitro Diagnostics (IVD) assays and platforms, with no need for any interface development. Our technology is now used in research studies, clinical trials, clinics and hospitals.

We truly believe that our technology can make a difference in cancer diagnostics by enabling clinicians to predict the possible metastases and to monitor the cancer therapy in real time.