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Pharmacelsus GmbH

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Saarbruecken, DE

About Pharmacelsus GmbH

Founded: 2000 Type: Privately Held Size: 11-50 employees

Located in Saarbrücken, Germany, Pharmacelsus provides the pharmaceutical and biotech industry with a range of high quality drug discovery and development solutions enabling them to make decisions at critical steps of the drug development process.

Pharmacelsus is your partner for GLP and non-GLP studies. The... Show more »

Located in Saarbrücken, Germany, Pharmacelsus provides the pharmaceutical and biotech industry with a range of high quality drug discovery and development solutions enabling them to make decisions at critical steps of the drug development process.

Pharmacelsus is your partner for GLP and non-GLP studies. The service portfolio encompasses in vitro and in vivo studies for preclinical drug discovery and development.

  • Discovery lead optimisation services / in vitro ADME characterization
  • Membrane transporter assays
  • Drug-drug interaction studies
  • In vivo pharmacokinetics & pharmacodynamics
  • Bioanalytical services (non-GLP)
  • Bioanalytical services (GLP, GCLP)
  • Dose formulation analytics
  • GLP method validation
  • Metabolite characterization
  • Target-based bioassays (endocrinology, diabetes)
  • In vitro services for target finding & biological profiling
  • Cytotoxicity testings (genotoxicity, immunotoxicity)
  • Customized Testing Services for Cosmetics and Dermaceuticals

Certifications: GLP Animal Welfare Audit by Novartis

Recent Publications:

L. Schyschka, J. J. Martínez Sánchez, Z. Wang, B. Burkhardt, U. Müller-Vieira, K. Zeilinger, A. Bachmann,S. Nadalin, G. Damm, et al., 'Hepatic 3D cultures but not 2D cultures preserve specific transporter activity for acetaminophen-induced hepatotoxicity,' Archives of Toxicology, 2013 June 01

Lübberstedt M, Müller-Vieira U, Biemel KM, Darnell M, Hoffmann SA, Knöspel F, Wönne EC, Knobeloch D, Nüssler AK, Gerlach JC, Andersson TB, Zeilinger K., 'Serum-free culture of primary human hepatocytes in a miniaturized hollow-fibre membrane bioreactor for pharmacological in vitro studies'., J Tissue Eng Regen Med. 2012 Nov 20

Hoffmann SA, Müller-Vieira U, Biemel K, Knobeloch D, Heydel S, Lübberstedt M, Nüssler AK, Andersson TB, Gerlach JC, Zeilinger K., 'Analysis of Drug Metabolism Activities in a Miniaturized Liver Cell Bioreactor for Use in Pharmacological Studies', Biotechnol Bioeng. 2012 Dec.

Mueller D, Müller-Vieira U, Biemel KM, Tascher G, Nüssler AK, Noor F., 'Biotransformation of diclofenac and effects on the metabolome of primary human hepatocytes upon repeated dose exposure', Eur J Pharm Sci. 2012 Feb 4.

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Our Services (39)


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Organoids

Price on request
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3D Cell Culture Models

Price on request
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In vitro ADME/DMPK Studies

Price on request

Both in vitro and in vivo ADME studies performed.
In vitro ADME:
- Physico-chemical parameters (solubility, lipophilicity)
- Stability
- Membrane permeability and transport (Pgp, Caco2, PAMPA, BBB)
- Protein binding (PPB, SPB, Kd)
- Drug interaction
- Metabolism (CYP inhibition, CYP induction, CYP phenotyping)
- Clearance

Both in vitro and in vivo ADME studies performed.
In vitro ADME:
- Physico-chemical parameters (solubility, lipophilicity)
- Stability
- Membrane permeability and transport (Pgp, Caco2, PAMPA, BBB)
- Protein binding (PPB, SPB, Kd)
- Drug interaction
- Metabolism (CYP inhibition, CYP induction, CYP phenotyping)
- Clearance

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In vitro PK/PD Studies

In vitro pharmacokinetics/pharmacodynamics
Price on request

In vitro pharmacokinetic studies:
Cytochrome P450 interaction according to FDA, EMA and BfArM
- CYP induction (human hepatocytes, HepaRG®)
- CYP inhibition (direct, metabolism-dependent and irreversible inhibition)
- CYP phenotyping (recombinantly expressed single P450 enzymes)
Membrane permeability and drug transporters
- Caco2 cell monolayers (bidirectional)
- Pgp interaction

In vitro pharmacokinetic studies:
Cytochrome P450 interaction according to FDA, EMA and BfArM
- CYP induction (human hepatocytes, HepaRG®)
- CYP inhibition (direct, metabolism-dependent and irreversible inhibition)
- CYP phenotyping (recombinantly expressed single P450 enzymes)
Membrane permeability and drug transporters
- Caco2 cell monolayers (bidirectional)
- Pgp interaction

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PBPK Modeling

In silico absorption, distribution, metabolism, and excretion
Price on request

We perform pharmacokinetic and toxicology modeling for the prediction of human and animal PK and toxicology.

Physiologically based pharmacokinetic (PBPK) modeling and simulation is an emerging in silico tool to predict drug pharmacokinetics (PK), including the effects on absorption, distribution, metabolism and excretion (ADME)... Show more »

We perform pharmacokinetic and toxicology modeling for the prediction of human and animal PK and toxicology.

Physiologically based pharmacokinetic (PBPK) modeling and simulation is an emerging in silico tool to predict drug pharmacokinetics (PK), including the effects on absorption, distribution, metabolism and excretion (ADME) processes. PBPK modelling enables investigation of changes in magnitude and time course of drug exposure in various tissues of humans or animals.

Pharmacelsus now provides PBPK models represented in Insilico Discovery™ (Insilico Biotechnology AG).

In combination with specific algorithms, the PBPK model allows quantitative in vitro / in vivo extrapolation with a minimum of in vitro experiments. For prediction of intraveneous (iv) and extravascular (ev) pharmacokinetic parameters of drug candidates, physico-chemical parameters like MW, logP, logD and pKa have to be provided.

Using material from the preclinical species of choice, only plasma protein binding and metabolic stability (liver microsomes or hepatocytes) need to be determined experimentally in vitro, since the model is independent of in vitro absorption data.

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In vivo PK/PD Studies

Price on request

Both in vitro and in vivo ADME studies performed.
In vitro ADME:
- Physico-chemical parameters (solubility, lipophilicity)
- Stability
- Membrane permeability and transport (Pgp, Caco2, PAMPA, BBB)
- Protein binding (PPB, SPB, Kd)
- Drug interaction
- Metabolism (CYP inhibition, CYP induction, CYP phenotyping)
- Clearance

Both in vitro and in vivo ADME studies performed.
In vitro ADME:
- Physico-chemical parameters (solubility, lipophilicity)
- Stability
- Membrane permeability and transport (Pgp, Caco2, PAMPA, BBB)
- Protein binding (PPB, SPB, Kd)
- Drug interaction
- Metabolism (CYP inhibition, CYP induction, CYP phenotyping)
- Clearance

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In vivo ADME/DMPK Studies

Price on request

In vivo pharmacokinetic studies:
Exploratory/orientating pharmacokinetic studies
- Determination of basic PK parameters
- Dried Blood Spot PK
- Cassette Dosing
- Identification of major metabolites
Full pharmacokinetic profiling
- Dose proportionality
- Organ distribution and excretion, mass balance
- Metabolism/ First... Show more »

In vivo pharmacokinetic studies:
Exploratory/orientating pharmacokinetic studies
- Determination of basic PK parameters
- Dried Blood Spot PK
- Cassette Dosing
- Identification of major metabolites
Full pharmacokinetic profiling
- Dose proportionality
- Organ distribution and excretion, mass balance
- Metabolism/ First Pass-effect/ Elimination
- Bioequivalence studies (comparison of different formulations)
- PK/PD relationship based on assessment of biomarkers that can be quantified by ELISA, flow cytometry or LC-MS

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Biomarker Analysis

Price on request

GCLP, GLP AND NON-GLP BIOANALYSIS
Preclinical and clinical samples
• Plasma, tissue, urine, faeces levels
• Metabolite identification and characterisation
• Identification of major metabolites
• Biomarker quantification
GLP method development and validation
GLP bioanalysis for multi-site toxicology studies and clinical trials

GCLP, GLP AND NON-GLP BIOANALYSIS
Preclinical and clinical samples
• Plasma, tissue, urine, faeces levels
• Metabolite identification and characterisation
• Identification of major metabolites
• Biomarker quantification
GLP method development and validation
GLP bioanalysis for multi-site toxicology studies and clinical trials

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Metabolite Profiling

Price on request

GCLP, GLP AND NON-GLP BIOANALYSIS
Preclinical and clinical samples
• Plasma, tissue, urine, faeces levels
• Metabolite identification and characterisation
• Identification of major metabolites
• Biomarker quantification

GCLP, GLP AND NON-GLP BIOANALYSIS
Preclinical and clinical samples
• Plasma, tissue, urine, faeces levels
• Metabolite identification and characterisation
• Identification of major metabolites
• Biomarker quantification

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Predictive Toxicology

Price on request

IN VITRO TOXICOLOGY
Cytotoxicity
Mechanistic toxicity
Hepatotoxicity
Immunotoxicity
Genotoxicity
Reactive metabolite screening
Predictive toxicology
2D cell culture and 3D organoid cultures

IN VITRO TOXICOLOGY
Cytotoxicity
Mechanistic toxicity
Hepatotoxicity
Immunotoxicity
Genotoxicity
Reactive metabolite screening
Predictive toxicology
2D cell culture and 3D organoid cultures

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Endocrine Disruptor Screening

Price on request

EDSP testing for the agriculture, chemical, pesticide and personal care industries.

To meet the requirements of the OECD Conceptual Framework for Testing and Assessment of Endocrine Disruptors, as included in the Guidance Document 150 (Annex 1.4), the following testing services are available:
Level 1:
- physico-chemical... Show more »

EDSP testing for the agriculture, chemical, pesticide and personal care industries.

To meet the requirements of the OECD Conceptual Framework for Testing and Assessment of Endocrine Disruptors, as included in the Guidance Document 150 (Annex 1.4), the following testing services are available:
Level 1:
- physico-chemical properties
- ADME predictions
Level 2:
- Steroidogenesis (Human cell line - H295R)
- Aromatase (Human recombinant, screening)
- MCF-7 cell proliferation assay
Level 3:
- Uterotrophic Assay (Rat)
- Hershberger Bioassay (Rat)

Endocrinology Assays
- 5α-reductase inhibitors (type I and type II)
- aromatase (CYP19) inhibitors
- LHRH (GnRH) a(nta)gonists
- CYP17 inhibitors
- CYP11B1 and CYP11B2 inhibitors

All studies are performed according to the principles of GLP and the Pharmacelsus team has a proven track record with over 30 years of experience in steroid endocrinology for pharmaceutical research.

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In vivo Drug Efficacy Testing

Price on request

In vivo experiments on preclinical species like mouse and rat. Several in vivo models have been established and characterized for a variety of endocrinological and metabolic diseases, being evaluated and performed in accordance with animal welfare legislation.

In vivo experiments on preclinical species like mouse and rat. Several in vivo models have been established and characterized for a variety of endocrinological and metabolic diseases, being evaluated and performed in accordance with animal welfare legislation.

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Endocrine Disease Animal Models

Price on request

In vivo experiments on preclinical species like mouse and rat. Several in vivo models have been established and characterized for a variety of endocrinological and metabolic diseases, being evaluated and performed in accordance with animal welfare legislation.

In vivo experiments on preclinical species like mouse and rat. Several in vivo models have been established and characterized for a variety of endocrinological and metabolic diseases, being evaluated and performed in accordance with animal welfare legislation.

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Metabolic Disease Animal Models

Price on request

In vivo experiments on preclinical species like mouse and rat. Several in vivo models have been established and characterized for a variety of endocrinological and metabolic diseases, being evaluated and performed in accordance with animal welfare legislation.

In vivo experiments on preclinical species like mouse and rat. Several in vivo models have been established and characterized for a variety of endocrinological and metabolic diseases, being evaluated and performed in accordance with animal welfare legislation.

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Diabetes Animal Models

Price on request

Pharmacelsus has a proven track record on conducting in vitro and in vivo studies on potency, selectivity and efficacy in diabetes models.

Pharmacelsus has a proven track record on conducting in vitro and in vivo studies on potency, selectivity and efficacy in diabetes models.

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Obesity Animal Models

Price on request

Pharmacelsus has a proven track record on conducting in vitro and in vivo studies on potency, selectivity and efficacy in obesity models.

Pharmacelsus has a proven track record on conducting in vitro and in vivo studies on potency, selectivity and efficacy in obesity models.

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Liver Fibrosis Animal Models

Price on request

Liver fibrosis induced by bile duct ligation in rats

Liver fibrosis induced by bile duct ligation in rats

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Rat

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Custom Cell-Based Assay Development

Price on request

Custom cell-based assays using engineered cells or primary cell cultures. If required, ex vivo assays are performed after preparation of tissue fragments or isolation of cells from target tissues in order to identify compounds showing the desired effect. Each study will be designed individually according to the individual needs.

Custom cell-based assays using engineered cells or primary cell cultures. If required, ex vivo assays are performed after preparation of tissue fragments or isolation of cells from target tissues in order to identify compounds showing the desired effect. Each study will be designed individually according to the individual needs.

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Mammalian Cell Culture

Price on request

2D cell culture and 3D organoid cultures

2D cell culture and 3D organoid cultures

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Histamine Release Assay

Price on request

Pharmacelsus has a proven track record on conducting in vitro and in vivo studies on potency, selectivity and efficacy of modulators of histamine release.

Pharmacelsus has a proven track record on conducting in vitro and in vivo studies on potency, selectivity and efficacy of modulators of histamine release.

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ADME/DMPK Studies

Drug Metabolism and Pharmacokinetics
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Computational Modeling

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Metabolic Animal Models

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Specialized Cell-Based Assays

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Safety Pharmacology

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Endocrinology Animal Models

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Biomarkers

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Pharmacology & Toxicology

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Omics

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Animal Models of Disease

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Hepatic Animal Models

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Metabolomics

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Cells and Tissues

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Cell-Based Assays

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Biology

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Animal Models and Studies

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Bioanalysis

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Drug Discovery & Development

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Drug Discovery & Development Services

Drug Discovery & Development Services

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Pharmacology

Price on request

Pharmacology Services

Pharmacology Services

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Stefanie Becker

Inside Sales & Marketing Manager
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Stephanie Urschel

Head of Marketing and Sales

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