DISCOVERY BIOANALYSIS
Our laboratories are equipped with UHPLC systems linked to high resolution, accurate mass QTof and triple quadrupole mass spectrometers.
The team has extensive experience in bioanalytical techniques and in the ADMET field as a whole, gained both from the CRO environment and previously at several of the world’s leading pharmaceutical R&D organizations.
| Areas of Expertise | State of the art bioanalytical and analytical equipment |
|---|---|
| Expertise in method development for small molecules, peptides and other modalities | |
| Provide support for studies performed at Pharmidex and also those performed at your own choice of CRO | |
| Tiered approach to validation, and flexible reporting options |
www.pharmidex.com
AUTOIMMUNE DISEASES
Alopecia
Cyclophosphamide, cisplatin, fluorouracil
- Various species
- Maximum study duration: 2 months
- Routes of administration: Topical, oral, intraperitoneal and subcutaneous
Multiple Sclerosis (EAE)
MOG35-55 peptide and proteolipid protein
- Various species
- Maximum study duration: 3 months
- Drug treatment observation period: 40 days.
- Routes of Administration: Oral, intraperitoneal, intranasal, intravenous, intrathecal and subcutaneous
Atopic Dermatitis
Haptens, OVA and HDM model
- Various species
- Maximum study duration: 3 months.
- Routes of administration: Topical, oral, intraperitoneal, intravenous and subcutaneous
Psoriasis
Imiquimod model
- Various species
- Maximum study duration: 3 weeks
- Routes of administration: Topical, oral, intraperitoneal, intranasal, intravenous and subcutaneous
Vitiligo
Monobenzene
- Single species
- Maximum study duration: 13 weeks
- Routes of administration: Topical
www.pharmidex.com
PHARMACOKINETICS
Our Services
- Fully integrated in vivo/bioanalysis/PK parameter determination
- Short lead times and rapid delivery of in vivo studies
- Bespoke protocol designs available
- PK profiling in a range of pre-clinical species
- Multiple routes of dose administration including specialized routes (please enquire)
- Surgical models in-house, including serial bile collection in Bile Duct Catheterized species
- Collection of multiple tissue samples for drug distribution studies
- Metabolic cages for clearance assessment in urine/faeces
- CSF collection in multiple pre-clinical species
- In Situ BBB permeability and efflux transporter assessment
- AAALAC accredited and IACUC/OLAW approved
- PK scaling to humans / human dose prediction and efflux transporter assessment
- Specialist models for CNS including microdialysis
In Vitro ADMET Services
Binding Assays
Biological Stability
Metabolic Stability
Physicochemical Properties
CYP450 Interaction
Metabolite Identification
Chemical Stability Assays
In vitro Cellular Toxicity Assays
Drug Transport
www.pharmidex.com
CNS RESEARCH
We currently offer a range of techniques to support the progression of CNS drug candidates.
Specialist expertise in in vivo and ex vivo neurochemistry and neurobehaviour.
We provide PK, PD, target engagement and efficacy information for novel therapeutic agents in development.
Extensive experience supporting the progression of candidate drugs for the treatment of neurodegenerative and psychiatric disorders, such as Alzheimer’s, Parkinson’s and Huntington’s disease, schizophrenia or depression.
www.pharmidex.com
Bioanalysis
LC-MS/MS
Multiple neurotransmitter analysis in microdialysates,
brain tissue, or CSF following sample derivatisation (PK/PD)
Extracellular (free) drug levels in microdialysates and plasma levels
Receptor Occupancy (target engagement)
BBB assessment
In vivo free brain/free plasma ratio at steady state
In situ brain perfusion for brain uptake index and active influx/efflux
In vitro BBB equilibrium dialysis
Animal Models
Discrete brain lesioning/central administration
Intracranial, intracerebroventricular or intrathecal administration
Pharmacological manipulation
Neuroinflammation
Transgenic animals
Stroke (Middle Cerebral Artery Occlusion)
DRUG METABOLISM SERVICE
Primarily using UHPLC - high resolution / accurate mass spectrometry, Pharmidex scientists can carry out studies of drug metabolism.
Our highly experienced team can help to resolve issues with high clearance, characterize metabolite profiles across species, and investigate potential reactive metabolism liabilities.
Areas of Expertise
- Identification of metabolically labile sites
- Cross-species metabolite profiling
- Structural characterisation of metabolites
- Identification of potential sites of reactive metabolism
- Assistance with optimising study design
www.pharmidex.com
DRUG METABOLISM SERVICE
Pharmidex offers a comprehensive drug metabolism service, primarily using UHPLC–high resolution mass spectrometry.
Our highly experienced team can help to resolve issues with high clearance, characterize metabolite profiles across species, and investigate potential reactive metabolism liabilities.
Areas of Expertise
- Identification of metabolically labile sites
- Cross-species metabolite profiling
- Structural characterisation of metabolites
- Identification of potential sites of reactive metabolism
www.pharmidex.com
www.pharmidex.com
INFLAMMATION
Pharmidex provides high quality research services to progress compounds from hit identification to lead optimization in gastrointestinal disease models such as inflammatory bowel disease.
Inflammatory Disease Services
In vivo assays/models provided includes:
- Ulcerative colitis models (DSS or TNBS-induced in preclinical species)
- Intestinal fibrosis (DSS or TNBS-induced in preclinical species)
We provide PK, PD, target engagement and efficacy information for client’s prospect therapeutics and have a track record of progressing their candidate therapeutics through to clinical evaluation in this area.
Inflammatory Bowel Disease
Areas of Expertise:
- We offer translatable inflammatory disease models to the pharma industry
- We have a variety of validated models for gastrointestinal diseases
www.pharmidex.com
IN SILICO DRUG DISCOVERY
Target determination & validation
- Pathway exploration and analysis
- Homology modelling and structure prediction
- X-Ray crystallography and Cryo-EM structure refinement
- Molecular dynamics analysis
- Protein flexibility, multimer association and active/inactive conformation analysis
Hit and binding sites Identification
- Library mining and extraction
- Identification and de novo design
- 2D & 3D-Ligand based design
- Binding site Identification: Multiple pocket sourcing definition, structure based design
Molecular docking &
3D-pharmacophore
- High-Throughput score-ranked drug-protein docking
- Positive and negative controls based on existed structures
- 3D-Pharmacophore determination
ADME/T & PK/PD Prediction
- Drug capacity to be effective in the body
- Drug ability to reach its target in sufficient concentration
- Key drug Variables: pharmacokinetics, physicochemical properties, medicinal chemistry friendliness and drug-likeness
www.pharmidex.com
IN SILICO DRUG DISCOVERY
Target determination & validation
- Pathway exploration and analysis
- Homology modelling and structure prediction
- X-Ray Crystallography and Cryo-EM structure refinement
- Molecular dynamics analysis
- Protein flexibility, multimer association and active/inactive conformation analysis
Hit and binding sites Identification
- Library mining and extraction
- Identification and de novo design
- 2D & 3D-Ligand based design
- Binding site Identification: Multiple pocket sourcing definition, structure-based design
Molecular docking &
3D-pharmacophore
- High-Throughput score-ranked drug-protein docking
- Positive and negative controls based on existed structures
- 3D-Pharmacophore determination
ADME/T & PK/PD Prediction
- Drug capacity to be effective in the body
- Ability to reach its target in sufficient concentration
- Key drug Variables: pharmacokinetics, physicochemical properties, medicinal chemistry friendliness and drug-likeness
www.pharmidex.com
MEDICINAL CHEMISTRY
Computational Chemistry
Propelling drug discovery forward with cutting-edge computer simulations and modeling techniques, yielding top-tier hits and optimizing leads
Synthetic Chemistry
Deliver of meticulously characterized, high-quality novel molecules swiftly, employing a diverse array of complex synthetic pathways. Additionally, offering process impurity identification, metabolite analysis and development for both intermediates and target compounds.
Medicinal Chemistry
Pharmidex specializes in providing precise medicinal chemistry solutions to produce superior drug candidates. Our expertise encompasses library synthesis and the utilization of premium building blocks to ensure excellence in every aspect of drug development
Analytical Chemistry
Providing a comprehensive suite services of impurity profiling, purifications (chiral compounds), stability studies (ICH guidelines), physical characterisation (DSC, TGA, XRD), and characterisation of reference standards.
Pharmidex offers comprehensive drug discovery services to expedite clients' IND submissions.
Our medicinal chemistry services cover hit-to-Lead and lead optimisation, accelerating drug discovery process.
We collaborate closely with clients to design focused libraries and ensure timely delivery of target compounds.
www.pharmidex.com
Pharmidex GLP/GCP Bioanalysis
As a GLP/GCP accredited company Pharmidex offers bioanalytical solutions to meet all your drug development requirements
We operate from modern state-of-the-art laboratories driven by staff with many years of experience in regulated bioanalysis
Our clients range from small start-ups to large institutions and we are always willing to offer advice on your analytical requirements.
Meet our GLP/GCP Bioanalysis experts: [email protected]
www.pharmidex.com
METABOLIC DISORDERS
Pharmidex can provide in vitro assays and in vivo animal models to investigate the efficacy of the compounds in metabolic disorders (obesity, diabetes, NASH) and kidney diseases including AKPKD (autosomal dominant polycystic kidney disease).
Diabetes
- Chemically Induced Model (Streptozotocin, Alloxan)
- Duration: Maximum 40 weeks
- Species: Rat, Mice
- Routes of Administration: IV, PO, SC, IP, IN
- Genetic models: Rat and Mice Zucker Diabetic Fatty (ZDF) Rat, AKITA MICE, db/db.
- Body weight glucose tolerance, insulin sensitivity and/or insulin tolerance
- Biomarkers analysis
Obesity
- Diet induced Obesity (DIO)
- Diet induced NASH (Non-alcoholic Steatohepatitis)
- Duration: Maximum 40 weeks
Species: Rat, Mice
- Routes of Administration: IV, PO, SC, IP, IN
- Genetic models: Rat and Mice
Zucker fatty rats
- Body weight glucose tolerance, insulin sensitivity and/or insulin tolerance
- Biomarkers analysis
Kidney Diseases
- Chemically Induced Model (Adriamycin, Folic acid)
- Allergen Induced Model (LPS)
- Tamoxifen Induced ADPKD
- Duration: Maximum 30 weeks
- Species: Rat, Mice
- Routes of Administration: IV, PO, SC, IP, IN
- Genetic models: Rat and Mice
- Urine analysis and imaging
www.pharmidex.com
PHYSICOCHEMICAL PROPERTIES
An understanding of simple physicochemical properties can help drive the lead identification and optimization phases of drug discovery.
Areas of Expertise
At Pharmidex we can conduct the following analysis to determine whether your compound of interest has the optimal physicochemical properties for progression into development.
Key Services
- pH solubility/stability
- Partition coefficient (Log D) assay
- Thermodynamic solubility
REGULATORY BIOANALYSIS
We provide GLP/GCP compliant analytical services for preclinical and clinical development, covering PK, TK and biomarkers.
Areas of Expertise
Highly skilled and experienced staff in regulatory bioanalysis, including unstable drugs and metabolites, working from modern MHRA accredited laboratories with state-of-the-art UHPLC and LC-MS/MS.
Our team ensures confidence in data generated through compliance with the appropriate GLP and GCP regulations and ICH M10 guidance.
Key services
- Stability issues, matrix effects and determination of multiple metabolites
- Quantitative analysis of drugs, metabolites and biomarkers from a range of matrices (plasma, serum, blood, CSF, urine, etc)
- SEND Formatting
www.pharmidex.com
- Analysis using small sample volumes
- Flexible support according to client requirements
- Method development, transfer and validation capabilities for novel and established compounds
Respiratory Services
- Acute lung injury (endotoxin-induced)
- Airway function
- ARDS
- Allergic rhinitis (OVA-induced)
- Asthma (steroid-sensitive and insensitive; HDM, OVA or Alternaria-induced)
- Asthma exacerbations (HDM or OVA and infection-induced)
- Bronchospasm (Histamine or cholinergic induction)
- COPD (ozone induced)
- Cough (citric acid or capsaicin induced)
- Chronic cough (citric acid induced in models of asthma/IPF, with histamine or ATP)
- Pulmonary fibrosis (bleomycin-induced)
- Pulmonary infection (Influenza A and respiratory syncytial virus)
- In vitro assays (Isolated animal and human airways, animal and human inflammatory cells, plaque assays)
Respiratory Disease
With over 22 years of experience in the field, offering translatable inflammatory disease models to the pharma/biotech industry.
We have a variety of fully validated models for respiratory disease (asthma, COPD, allergic rhinitis, IPF and lung infection) providing a comprehensive research service, including pharmacodynamic assays and translatable respiratory disease models.
www.pharmidex.com
Respiratory Disease
With over 22 years of experience in the field, we combine our specialist knowledge, pharmacodynamic assays and translatable respiratory disease models to provide PK/PD and efficacy information to clients in the pharma/biotech industries to progress their therapeutics through to clinical development.
www.pharmidex.com
Respiratory Services
- Acute lung injury (endotoxin-induced)
- Airway function
- ARDS
- Allergic rhinitis (OVA-induced)
- Asthma (steroid-sensitive and insensitive; HDM, OVA or Alternaria-induced)
- Asthma exacerbations (HDM or OVA and infection-induced)
- Bronchospasm (Histamine or cholinergic induction)
- COPD (ozone induced)
- Cough (citric acid or capsaicin induced)
- Chronic cough (citric acid induced in models of asthma/IPF, with histamine or ATP)
- Pulmonary fibrosis (bleomycin-induced)
- Pulmonary infection (Influenza A and respiratory syncytial virus)
- In vitro assays (Isolated animal and human airways, animal and human inflammatory cells, plaque assays)
TOXICOLOGY
We provide tailored support for small molecules and biologics, serving as an integral extension of your team, covering general toxicology studies for discovery or development programs, with or without GxP regulatory compliance, integrating safety pharmacology protocols into these studies.
Our MHRA and OLAW and AAALAC accredited toxicology department will help you with your preclinical and other early-stage product development needs to assure product safety and regulatory compliance.
Areas of Expertise
Pharmidex will design and implement standard and customised bespoke preclinical discovery or regulatory toxicology studies in our HO, MHRA, OLAW and AAALAC accredited in vivo toxicology facility.
Key Features
- Discovery toxicology: tolerability and acute toxicity (MTD, DRF)
- Regulatory toxicology: OECD-compliant GLP toxicity studies
- A complete range of administration routes
- Clinical pathology sample analyses
- Histopathology processing and support
Pharmidex Toxicology Capabilities (GLP/Non-GLP)
Routes of Administration
-In diet or drinking water -Oral gavage
-Rectal -Intravaginal -Intravenous
-Subcutaneous -Intraperitoneal
-Intramuscular -Intracranial -Intranasal
Topical application (skin/ocular/buccal)
-Via i.v./s.c./i.p. implanted cannula
-Via s.c./i.p. implanted osmotic minipump
-Subcutaneous or orthotopical surgical minimally invasive implantation of biomaterials or medical implants
Applications
- General discovery toxicology
- Regulatory GLP toxicology
- Single dose studies (MTD)
- Repeat dose studies (DRF)
- Toxicokinetic studies
- Necropsy
- Clinical pathology
- Histopathology
Supporting Capabilities
- Analytical chemistry
- Bioanalysis
- Biodistribution
- Dose formulation analysis
- Anatomic pathology
- Cytokine and biomarker analysis
- Clinical pathology
- Immunohistochemistry
www.pharmidex.com
TOXICOLOGY
We provide tailored support for small molecules and biologics, serving as an integral extension of your team, covering general toxicology studies for discovery or development programs, with or without GxP regulatory compliance, integrating safety pharmacology protocols into these studies.
Our MHRA and OLAW and AAALAC accredited toxicology department will help you with your preclinical and other early-stage product development needs to assure product safety and regulatory compliance.
Areas of Expertise
Pharmidex will design and implement standard and customised bespoke preclinical discovery or regulatory toxicology studies in our HO, MHRA, OLAW and AAALAC accredited in vivo toxicology facility.
Key Features
- Discovery toxicology: tolerability and acute toxicity (MTD, DRF)
- Regulatory toxicology: OECD-compliant GLP toxicity studies
- A complete range of administration routes
- Clinical pathology sample analyses
- Histopathology processing and support
Pharmidex Toxicology Capabilities (GLP/Non-GLP)
Routes of Administration
-In diet or drinking water -Oral gavage
-Rectal -Intravaginal -Intravenous
-Subcutaneous -Intraperitoneal
-Intramuscular -Intracranial -Intranasal
Topical application (skin/ocular/buccal)
-Via i.v./s.c./i.p. implanted cannula
-Via s.c./i.p. implanted osmotic minipump
-Subcutaneous or orthotopical surgical minimally invasive implantation of biomaterials or medical implants
Applications
- General discovery toxicology
- Regulatory GLP toxicology
- Single dose studies (MTD)
- Repeat dose studies (DRF)
- Toxicokinetic studies
- Necropsy
- Clinical pathology
- Histopathology
Supporting Capabilities
- Analytical chemistry
- Bioanalysis
- Biodistribution
- Dose formulation analysis
- Anatomic pathology
- Cytokine and biomarker analysis
- Clinical pathology
- Immunohistochemistry
www.pharmidex.com
TOXICOLOGY
We provide tailored support for small molecules and biologics, serving as an integral extension of your team, covering general toxicology studies for discovery or development programs, with or without GxP regulatory compliance, integrating safety pharmacology protocols into these studies.
Our MHRA and OLAW and AAALAC accredited toxicology department will help you with your preclinical and other early-stage product development needs to assure product safety and regulatory compliance.
Areas of Expertise
Pharmidex will design and implement standard and customised bespoke preclinical discovery or regulatory toxicology studies in our HO, MHRA, OLAW and AAALAC accredited in vivo toxicology facility.
Key Features
- Discovery toxicology: tolerability and acute toxicity (MTD, DRF)
- Regulatory toxicology: OECD-compliant GLP toxicity studies
- A complete range of administration routes
- Clinical pathology sample analyses
- Histopathology processing and support
www.pharmidex.com
Toxicology Capabilities (GLP/Non-GLP)
Routes of Administration
-In diet or drinking water -Oral gavage
-Rectal -Intravaginal -Intravenous
-Subcutaneous -Intraperitoneal
-Intramuscular -Intracranial -Intranasal
Topical application (skin/ocular/buccal)
-Via i.v./s.c./i.p. implanted cannula
-Via s.c./i.p. implanted osmotic minipump
-Subcutaneous or orthotopical surgical minimally invasive implantation of biomaterials or medical implants
Applications
- General discovery toxicology
- Regulatory GLP toxicology
- Single dose studies (MTD)
- Repeat dose studies (DRF)
- Toxicokinetic studies
- Necropsy
- Clinical pathology
- Histopathology
Supporting Capabilities
- Analytical chemistry
- Bioanalysis
- Biodistribution
- Dose formulation analysis
- Anatomic pathology
- Cytokine and biomarker analysis
- Clinical pathology
- Immunohistochemistry
www.pharmidex.com
At Pharmidex, we're proud to offer our clients access to 16,000+ Preclinical Models.
Our extensive partnership networks provide:
6,000+ Off-the-shelf Models
Our team manages and conducts complete research programs, delivering seamless end-to-end services.
We deliver cost-effective, high-quality research tailored to your needs.
11,000+ Genetically Engineered Models
We operate our AAALAC-accredited, state-of-the-art vivarium, ensuring exceptional care and bespoke study packages.
Transgenic & Humanized Models
Pharmidex offers a wide range of services and customizable analytical readouts, maximizing the impact of your experiments.
6,000+ Off-the-shelf Models
Our team manages and conducts complete research programs, delivering seamless end-to-end services.
We deliver cost-effective, high-quality research tailored to your needs.
11,000+ Genetically Engineered Models
We operate our AAALAC-accredited, state-of-the-art vivarium, ensuring exceptional care and bespoke study packages.
Transgenic & Humanized Models
Pharmidex offers a wide range of services and customizable analytical readouts, maximizing the impact of your experiments.
At Pharmidex, we're proud to offer our clients access to 16,000+ Preclinical Models.
Our extensive partnership networks provide:
STROKE
Pharmidex are now offering in life work for stroke and our goal is to test and identify potential candidates that can be advanced to the clinical trials.
Pharmidex specialises in conducting preclinical studies for testing potential therapeutic agents for their ability to elicit neuroprotection.
