• Services for Regulatory ATMP Development
    Services for Regulatory ATMP Development

    Living biotherapeutics - Oncolytic viruses - AAV vectors

  • ATMP Biodistribution and Shedding Analysis
    ATMP Biodistribution and Shedding Analysis

    qPCR - CFU determination - Flow cytometry - EliSpot

  • MultiPlex miRNA Biomarker Discovery
    MultiPlex miRNA Biomarker Discovery

    Hydrogel particle-based >65-plex from small samples amounts

  • MultiPlex miRNA Clinical Profiling
    MultiPlex miRNA Clinical Profiling

    Pre-designed & custom >65-plex panels

Accelero Bioanalytics GmbH is a contract research laboratory located in Berlin, Germany:

  • Good Laboratory Practice (GLP) certified
  • ICH Good Clinical Practice (GCP) compliant
  • Maintaining Biosafety Level 2 laboratories

 

FIELDS OF ACTIVITY

  • Non-Clinical Studies (GLP)
  • Clinical Studies (GCP)
  • Advanced Therapy Medicinal Products (ATMP)
  • RNA / DNA Therapeutics & Aptamers
  • Microbiology
  • Cloning
  • Cell Isolation & Culture
  • Anti-Drug Antibodies (ADA)
  • GMP Cell Bank Characterization
  • Toxicokinetic - Biodistribution - Shedding

 

LABORATORY SERVICES

  • ELISA and Hybridization
  • Real-Time qPCR and RTqPCR
  • Flow Cytometry (FACS)
  • EliSpot and Triple FluoroSpot Immunoassays
  • Particle-Based Multiplex Immunoassays
  • Particle-Based Multiplex miRNA Assays
  • Protein and RNA Biomarker Microarrays
  • Pharmacokinetic / Toxicokinetic / Statistical Analysis
  • GxP Sample Collection and Shipment
  • Clinical Kits

 

CONSULTING SERVICES

  • Assay Development & Validation
  • GLP Seminars
  • GLP Basic Courses
  • GLP Talks (for Advanced)
  • GLP In-House Trainings (at your Test Facility)

GLP trainings and seminars are currently available in German speaking countries (Germany, Austria, Switzerland).

 

Please feel free to inquire additional information using our contact form, or send us an email to:

multiplex (at) accelero-bioanalytics.com (for multiplex immunoassay and multiplex miRNA assay services)
glppraxisnah (at) accelero-bioanalytics.com (for GLP trainings and seminars)
service (at) accelero-bioanalytics.com (for all other enquiries).

The Accelero team will be happy designing the most appropriate assay for your application.

 

  

ELISA and Hybridization

  • 96-well and 384-well assay format.
  • Direct quantification of drug substances and drug products for PK / TK characterization.
  • Inflammation marker quantification (cytokines, interferons, hormones).
  • Complement activation as a response to drug treatment.
  • Bead-based assays, e.g. like AlphaLISA.
  • Sandwich hybridisation assays for the quantification of drugs based on nucleic acid chemistry.
  • Ligation-based hybridization assays to quantify full length parent RNA or DNA compounds.
  • Branched DNA assays as an alternative for RTqPCR mediated RNA quantification, also for RNA transkript vaccines.
  • Immunogenicity testing, ADA screening, confirmation, and neuutralization assays (early IgM, late IgG).
  • Real-time enzyme activity assays.
  • Triglyceride and phospholipid determination (sphingosine-1-phosphate, ceramide, sphingosylphosphorylcholine, etc).

 

Real Time qPCR and RTqPCR

The following services are available for applications like drug quantification or expression analysis (please download a list of selected assays):

  • Relative ΔΔCt and/or absolute gene expression analysis.
  • Genomic DNA detection and/or quantification.
  • Direct quantification of human stem cells in xenograft models (e.g. in regulatory biodistribution studies).
  • Quantification of RNA transcript vaccines or antibody-encoding RNA transcripts.
  • Pharmacokinetic characterization of microRNA, siRNA, or immuno-modulatory DNA oligonucleotides.
  • Immuno qPCR for ultra-sensitive protein detection.
  • Impurity test of biotechnology-derived drug products (assay for host organism DNA and RNA).
  • Transgene copy number in Pichia pastoris.
  • Plasmid copy number in Escherichia coli.
  • Mycoplasma qPCR assays.
  • Microbiological analysis of biological samples.
  • Viable PCR (vPCR) for selective detection of DNA from viable cells.
  • New: RTqPCR mediated senescence verification of human mesenchymal cells after passaging in vitro.

 

Flow Cytometry (FACS)

The following services are available for cell culture, microbiology, and biomarker monitoring:

  • Absolute live/dead cell counting, cell proliferation assays, apoptosis assays, cell viability assays.
  • Cell type identification from culture and in vivo samples.
  • New: Isolation of blood cell subpopulations using magnetic particles, e.g. CD4+ (T-cells, monocytes, macrophages), CD8+ (cytotoxic T-cells), CD14+ (monocytes, macrophages), CD16+ (neutrophils), or CD19+ (lymphocytes), followed by flow cytometry QC.
  • ADCC assay (Antibody-dependent cell-mediated cytotoxicity).
  • ADCP assay (Antibody-dependent cellular phagocytosis).
  • CDC assay (Complement-dependent cytotoxicity).
  • Biomarker identification and monitoring as a clinical pharmacodynamic parameter.
  • Bacterial cultures live/dead cell counting.
  • New: Particle-based multiplex FirePlex® immunoassays.
  • New: Particle-based multiplex FirePlex® miRNA profiling assays, directly from biofluids, no extraction required.
  • Nanocarrier particle sizing and counting for drug product characterization.
  • Genomic DNA analysis, nucleic acid composition.
  • New: Epitope quantification on tissue-specific, viable cells after tissue dissociation.

FirePlex® is the new name for Abcam´s Firefly assays. FIREPLEX is a trademark registered by Abcam plc in the United States, and is an unregistered trademark elsewhere.

 

EliSpot and Triple FluoroSpot Immunoassays

The following services are available for cell-based immune response monitoring:

  • T-cell assays (based on interleukin detection).
  • B-cell assays (e.g. MabTech Human IgG/IgA/IgM FluoroSpot Kit).
  • Kits for many species available, e.g. like monkey, mouse, rat, cotton rat, pig, etc.
  • Please refer to the kit manufacturer´s website for product and assay details (Mabtech AB, Abcam plc, R&D Systems).
  • NEW: Virus plaque assays in 96-well format.

 

Protein and RNA Biomarker Microarrays

Accelero helps you to identify putative nucleic acid or protein biomarkers  in numerous non-clinical or clinical applications. No matter if you are looking for binding partners for your aptamer, or you need to screen your clinical samples for signal-dependent pathways, our team processes and analyzes your valuable samples:

  • Profile your samples against thousands of immobilized human proteins.
  • Discover specificity and target selectivity of your therapeutic antibody.
  • Screen protein expression profiles as a function of drug treatment.
  • Characterize off-target effects of your therapeutic aptamer.

 

Pharmacokinetic / Toxicokinetic / Statistical Analysis

 

Supply Chain: Sample Collection / Clinical Kits and GxP Shipment Organisation

Accelero provides assistance for the organization of your sample transfers: From the site of sample generation (usually the non-clinical or clinical study site) to the site of analysis (usually Accelero). Especially for small companies with limited human resources we help to organize:

  • Worldwide temperature sensitive sample transport: sample pickup, shipment, delivery.
  • Complete documentation: customs documents, delivery notes, certificates.
  • Real-time GLP or GCP temperature monitoring.

For bioanalytical studies placed with Accelero, we prepare and distribute sample collection kits / clinical kits according to the EMA reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples (EMA/INS/GCP/532137/2010). This service certainly is also available for clinical multi-center studies, and includes:

  • Material selection according to the bioanalytical specifications (e.g. anticoagulant, volume).
  • Preparation of Instruction for Use protocols for the clinical personnel.
  • Pre-labelling of all tubes, bags, and sample boxes.
  • Unique barcode identifier for sample tubes, if required.
  • Separate, pre-labelled microcentrifuge tubes for aliquot preparation to avoid freeze-thaw cycles.
  • Quality check following the four-eyes principle.
  • Overnight express delivery, if required.

If you have to meet any requirements which have not been listed here, please do not hesitate to get in touch with us for additional information. Accelero will be delighted to help you!

 

Please visit our corporate website accelero-bioanalytics.com for further information.

 

Last update of this site: 21-JAN-2019 by Christian Lange