Accelero Bioanalytics

The creation of a complete new business paradigm: This is Accelero Bioanalytics GmbH
Ligand Binding Assays in full compliance to Good Laboratory Practice (GLP)?
Cell Based Assays in full compliance to Good Manufacturing Practice (GMP)?
Both of them without providing own facilities?
Join in when an innovative marketing model comes into action!

Welcome to Accelero(R) Bioanalytics GmbH
Your GxP Compliant Ligand Binding Assay Partner

Accelero(R) Bioanalytics GmbH is a biotech contract research organization (CRO) focussing on the emerging field of Ligand Binding Assays of virtually any kind. Our expertise is the bioanalytics of innovative therapeutics based on nucleic acid or protein/peptide chemistry. Our customers can benefit from a complete new business model.

Accelero(R) Bioanalytics GmbH supports pharmacokinetic and pharmacodynamic preclinical and clinical drug development on microRNA, miRNA, siRNA, aptamers, antisense drugs, as well as peptide hormones, biosimilars, or antibody therapeutics, right from the start.

Innovative, ultrasensitive immunoassay technologies like immuno qPCR or proximity ligation assays allow for peptide/protein quantification in real time.

What you can expect: Our Services
- Ligand Binding Assay GLP Lab Capabilities
- GMP Cell Based Assays
- Radiolabel Biodistribution
- EU FP7 Grant Support
- GLP Study Documentation</font>

Accelero(R) Bioanalytics GmbH is one of the first to offer GLP compliant bioanalytical Real-Time RT-qPCR, including human diagnostics.

Our experience in this field includes:
- Pharmacokinetics / toxicokinetics
- Pharmacodynamics
- Mouse, rat, cynomolgus, human
- Biodistribution
- Bioanalysis of virtually any biological matrix
- Strong molecular biological background
- >6 years bioanalysis of aptamers
- >5 years bioanalysis of formulated siRNA</font>

Our clients request:
- Phase I bioequivalence PK studies comprising biosimilars/protein therapeutics
- Phase I PK/PD bioanalysis of a nucleic acid therapeutic compound
- PK of labelled Fc fusion proteins in mice
- siRNA quantification in samples derived from nanocarrier process optimization
- GMP compliant cell-based assays enabling biosimilars stability testing
- Immunogenicity testing of biosimilars according to EMA Guideline
- Phase I MRSA qPCR quantification in human nasal swaps
- RNA quantification in API Plasmids derived from GMP production
- PK of human cell therapeutics in preclinical studies

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

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Ligand Binding Assay GLP Lab Capabilities
We offer Good Laboratory Practice services by providing own analytical instruments embedded in a Good Laboratory Practice (GLP) environment:
- Sandwich hybridisation assays
- Ligation-based hybridisation assays
- Real-time RT-qPCR assays
- Immuno qPCR (iqPCR)
- Proximity Ligation Assays (PLA)
- Antibody detection (ADA) according to the EMA Guideline (screening, confirmation, neutralization)
- AlphaLISA® assays
- TaqMan® arrays
- Complement activation assays
- Biomarker, cytokine assays
- Enzyme Activity Assays (e.g. Telomerase)
- Glucose Determination Assays
- Endotoxin Assays
- In vitro plasma binding studies
- Immunoprecipitation
- Bead-based assays

Our equipment comprises:
- Biotek Synergy 2 Multimode Plate Reader
- Applied Biosystems Viia7 Real-Time qPCR System, IVD Label for Human Dx
- both capable to read and analyse data from 384 well assay plates

We also provide the ligand binding assay development of cell-based procedures like:
- Bioactivity assays of biosimilars, monoclonal antibodies (e.g. FACS analysis)
- Antibody dependent cell cytotoxicity (ADCC) assays
- complement dependent cytotoxicity (CDC) assays

ICH Guideline Q2 (R1) for GMP compatibility
EMA Guideline for Bioanalytical Method Development are obligatory.

Biodistribution of 3H Labelled Compounds
Our services also include biodistribution studies applying radioactive labelled compounds
(eg. tritium 3H labelled nucleic acids). We have access to modern and new radionuclide lab facilities.

FP7 Grant Support
As a small entrepeneurship we are the ideal partner for scientific consortiums who are planning to apply for an European FP7 grant.

Our experience in this field includes:
- pharmacokinetics/toxicokinetics eg for acute/subcronic tox studies
- infusion, single/repeated bolus IV, SC, IP, IM dosing
- diffferent species like mouse, rat, cynomolgus, human
- biodistribution in mice
- bioanalysis of virtually any biological matrix like:
plasma, blood, blood cells, PBMCs
- organs like spleen, liver, kidney, lung, brain, pancreas, faeces
fluids like bronchoalveolar lavage (BAL), bile, urine, etc
- strong molecular biological background like:
- vector cloning, sequencing, blotting, 5´- and 3´- RACE, etc
- next generation sequencing library preps</font>

AlphaLISA(R) is a Trademark of Perkin Elmer Inc.
TaqMan(R) is a trademark of Roche Molecular Systems Inc.