• 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

The best lessions are learned through experience. The Accelero team has been working on numerous non-clinical GLP and clinical GCP studies - from first-in-man (FIM) and phase 1 to global phase 3. Clients from seven European countries benefit from Accelero´s strong background in method setup and validation e.g. for regulatory Advanced Therapy Medicinal Products (ATMP) development.

 

SELECTED THERAPEUTICS

See what kind of therapeutics Accelero has supported with its bioanalytical drug development expertise.

  • Human mesenchymal stem cells (non-clinical)
  • Genetically modified microbial cells (non-clinical)
  • Lyposomal siRNA formulation (non-clinical and clinical)
  • miRNA antagomir formulations (non-clinical)
  • RNA aptamer (non-clinical)
  • DNA aptamer (non-clinical and clinical)
  • DNA vaccine (non-clinical)
  • Oncolytic viruses (non-clinical and clinical)
  • Adeno-associated vectors (non-clinical)
  • Antibiotics (clinical)
  • Monoclonal antibodies (non-clinical)
  • Biosimilars (non-clinical)

 

SELECTED THERAPEUTIC AREAS

Accelero´s clients may be active in the following therapeutic areas:

  • Cardiovascular diseases
  • Cancer immunotherapy
  • Cancer treatment
  • Autoimmune diseases
  • Wound healing
  • Sepsis
  • Antibiotics
  • Eye diseases

 

SELECTED NON-CLINICAL STUDIES (GLP)

Please find below some examples for which Accelero has been selected as a bioanalytical service partner:

  • Pharmacokinetic characterization of drug substances and drug products in non-GLP dose range finding (DRF) studies in rodents, non-human primates, and minipigs (ELISA, qPCR).
  • GLP safety tox studies in rodents, non-human primates, hamsters, rabbits, and minipigs (ELISA, qPCR).
  • Plasmid GLP biodistribution in rodents and minipigs (qPCR).
  • Virus GLP biodistribution in hamsters (qPCR).
  • Shedding studies in minipigs (qPCR)

 

SELECTED CLINICAL STUDIES (GCP)

See where Accelero has a proven track record in serving biotechnology-driven clinical stage clients.

  • Pharmacokinetic characterization in first-in-man / phase 1 dose escalation studies (ELISA, qPCR).
  • Drug safety monitoring (ELISA), and accurately timed reporting to the Drug Safety Monitoring Board (DSMB).
  • Particle-based multiplex immunoassay for cytokine quantification in human serum, cerebrospinal fluid, and bronchoalveolar lavage (ELISA, hydrogel particle-based flow cytometry).
  • Micro-organism quantification in human sputum collected in global phase 3 studies (qPCR).

 

REFERENCES

Accelero Bioanalytics GmbH is fully committed to the idea of strikt confidentiality. For this reason Accelero will never publish client information on any of the websites hosted by Accelero Bioanalytics GmbH. Accelero will not disclose any client details without written permission. If you are interested in learning more about Accelero´s international clients, please feel free to send an email request to service (at) accelero-bioanalytics.com. We will be delighted to evaluate your request.

 

 

CASE STUDY 1: Allogenic Human Mesenchymal Stem Cell Product

Accelero has been involved in the regulatory development of an allogenic ATMP based on multipotent human mesenchymal stem cells. All study documents prepared and finalized by Accelero have been submitted to the competent regulatory authority.

Genomic DNA from tissues has been isolated in a high-throughput 96-well format. A selective and sensitive qPCR assay has been developed and validated to quantify human cells in rodent tissues after systemic or local administration. Flow cytometry has been applied to quantify viable human cells in cell suspensions for in vivo applications. In the course of this project the following bioanalytical studies have successfully been finalized:

  • Primary pharmacology (non-GLP).
  • Dose range finding in immunodeficient mouse strains (non-GLP).
  • Local biodistribution in immunodeficient mouse strains after local administration (GLP multi-site safety tox study).
  • Systemic biodistribution in immunodeficient mouse strains after local and/or systemic administration (GLP multi-site safety tox study).
  • Species-specific RTqPCR assay development to analyze human gene expression in rodent tissues.
  • Sample import into the European Union from a GLP certified U.S. test facility (GLP multi-site study).

 

CASE STUDY 2: Non-Replicating Adenovirus-Type Drug Product

 ... is still in preparation ... Please get back to this site later to see the full story.

 

CASE STUDY 3: DNA Aptamer Product

Accelero has been delighted to get involved in the regulatory development of an aptamer drug compound based on nucleic acid chemistry. A sensitive and selective enzyme-linked hybridization assay has been developed and validated according to the EMA guideline for bioanalytical method development. Main purpose was to quantify the aptamer in plasma and urine. Another test method has been developed and validated to check aptamer formulations for the correct drug substance content.

  • Non-clinical primary pharmacology (non-GLP).
  • Dose range finding studies in rodents and Beagle dogs (non-GLP).
  • Safety tox studies in rodents and Beagle dogs (GLP multi-site).
  • Clinical single-center phase 1 dose escalation study (compliant to ICH GCP and the EMA GCLP reflection paper).

 

Last update of this site: 26-APR-2018