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Seventh Wave Laboratories

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Maryland Heights, Missouri, US

About Seventh Wave Laboratories

Founded: 2003 Type: Privately Held Size: 51-200 employees

Seventh Wave Laboratories was established in 2003 by former Pharmacia/Pfizer nonclinical scientists and has continued to add experts with diverse pharmaceutical and contract research backgrounds. Located in St. Louis, Missouri, our laboratories are equipped with state-of-the-art technology and are continuously... Show more »

Seventh Wave Laboratories was established in 2003 by former Pharmacia/Pfizer nonclinical scientists and has continued to add experts with diverse pharmaceutical and contract research backgrounds. Located in St. Louis, Missouri, our laboratories are equipped with state-of-the-art technology and are continuously updated with the most modern research and analytical tools.

Our experienced and talented team is designed to enhance your capacity. Seventh Wave researchers have years of combined academic and industrial experience to provide you with an edge over your competitors. In addition, we prioritize collaboration, which means we want our clients to consider our facilities an extension of their own. We partner with you; our scientific and support teams work hand-in-hand to provide top-tier service and timely results throughout the drug development continuum.

With a diverse client base, Seventh Wave supports clients throughout the nation and around the world in the development of products that benefit humanity and our environment.

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Our Services (41)


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ADME/DMPK Studies

Drug Metabolism and Pharmacokinetics
Price on request

Our Drug Metabolism and Phamacokinetics Team provides expertise in DMPK studies at all stages of R&D—from lead optimization through NDA.

We can assign a pharmacokineticist to provide expert evaluation of your drug candidate whether your study is performed at Seventh Wave or at another laboratory. The same pharmacokineticist can... Show more »

Our Drug Metabolism and Phamacokinetics Team provides expertise in DMPK studies at all stages of R&D—from lead optimization through NDA.

We can assign a pharmacokineticist to provide expert evaluation of your drug candidate whether your study is performed at Seventh Wave or at another laboratory. The same pharmacokineticist can stay with your candidate, providing scientific continuity and consistency of evaluations throughout the life cycle of your compound.

Services include:

  • PK studies
  • A wide variety of protocols for all parameters, including:
    • Total and renal clearance
    • Volume of distribution
    • Terminal half-life
    • Bioavailability
    • PH Telemetry System Remote Measurement of Gastrointestinal pH in dogs
    • Bile duct cannulated models

PK/TK Analysis of data from client companies

  • GLP Compliant
  • Validated software, data handling SOPs, internal and external audit capabilities
  • Phoenix® WinNonlin® software; Validated, part 11 compliant
  • Non-compartmental and compartmental analyses
  • Bioequivalence/bioavailability assessments
  • Evaluation of dose, drug interactions, and more
  • Leverage preclinical data for clinical PK projections

Document Generation and Quality Systems

  • Provide or assist with protocol writing
  • Flexible report formats
  • Write or support technical and regulatory reports
  • Assist with publications, abstracts, and posters
  • Document Specialists and Quality Assurance Unit support
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Bioanalysis

Price on request

We provide rapid, high-quality, and flexible bioanalytical support. By developing and validating methods to fit your purpose and methodology, we are often able to save clients time and money.

Our support for small molecule bioanalysis is mass spec based and offered in three tiers:
- Level 1 - Typically to support discovery,... Show more »

We provide rapid, high-quality, and flexible bioanalytical support. By developing and validating methods to fit your purpose and methodology, we are often able to save clients time and money.

Our support for small molecule bioanalysis is mass spec based and offered in three tiers:
- Level 1 - Typically to support discovery, initial PK, screening or abbreviated discovery and validation
- Level 2 - Typically done to refine level 1 methods for dose selection, chronic efficacy studies, human PK predictions or expanded development and validation
- GLP - supports a fully compliant validation package for IND, CTA, BLA and NDA enabling

Additional bioanalytical services include:
- Tissue and fluid analyses
- Parent and metabolite identification and quantitation.
- Cassette Analyses
- Biomarkers
- De novo assay development and validation
- Dried blood spot
- Microsampling

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In vitro ADME/DMPK Studies

Price on request

Our in vitro services are flexible and diverse. We provide screening assays as needed, and develop novel assays to answer new questions. And, we offer routine in vitro services to enable regulatory filings. We deliver the correct assay, fit for purpose, to provide the appropriate level of rigor at the right point in time.
A... Show more »

Our in vitro services are flexible and diverse. We provide screening assays as needed, and develop novel assays to answer new questions. And, we offer routine in vitro services to enable regulatory filings. We deliver the correct assay, fit for purpose, to provide the appropriate level of rigor at the right point in time.
A partial list of our offering includes:
Metabolic Stability/Intrinsic Clearance
- Half-life and intrinsic clearance:
- Routine and customized assays
Plasma Protein Binding (Equilibrium Dialysis and Ultra filtration)
- Stage-appropriate assays for determination of unbound fraction
- Screening assays
- Definitive assay
Red Blood Cell Partitioning/Blood to Plasma Ratio
- Stage-appropriate assays to support in vitro/in vivo correlations and human clearance predictions
Cytochrome P450 Characterization of Metabolism
- Drug-Drug Interaction assays in liver microsomes
- Reaction Phenotyping
Metabolite ID/Metabolic Profiling
- Soft-spot analysis (identify metabolically labile areas)
- Cross-species metabolic profiling
Physical Chemical Property Assessment
- Solubility measurements (screening using turbimetry and thermodynamic assays)
- LogP (HPLC and shake slask technique)

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Toxicology

Price on request

We offer in vivo services in all common laboratory species. Flexible, fast, and responsive, our team and services are designed to support discovery and investigative toxicology. We routinely develop custom protocols to meet the challenges of client programs, but we also have a portfolio of routine protocols for client... Show more »

We offer in vivo services in all common laboratory species. Flexible, fast, and responsive, our team and services are designed to support discovery and investigative toxicology. We routinely develop custom protocols to meet the challenges of client programs, but we also have a portfolio of routine protocols for client utilization.

Standard protocols are in place to support:
- Acute tolerability
- Repeat dose studies
- Mechanistic investigation of target organ effects
- Correlate toxicity findings to systemic exposure (TK)
- Dose-ranging guidance for longer studies
- Complete necropsy, histopathology and DMPK support
- Novel protocol development to derisk and investigate drug candidate toxicity

Species supported:
- Mouse
- Rat
- Rabbit
- Dog
- Pig

Routes of administration
- Oral
- Intravenous
- Subcutaneous
- Dermal
- Buccal/sublingual
- Custom route development with discussion

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Humanized Mouse Models

Price on request

Seventh Wave offers pharmacology studies in liver humanized FRG® KO mice through a partnership with Yecuris to provide the most predictive approach available to study new human liver disease therapies. As with our other laboratory services, Seventh Wave supports our clients with study design, conduct, and result... Show more »

Seventh Wave offers pharmacology studies in liver humanized FRG® KO mice through a partnership with Yecuris to provide the most predictive approach available to study new human liver disease therapies. As with our other laboratory services, Seventh Wave supports our clients with study design, conduct, and result interpretation.

We have more than 2 years of experience developing and validating pharmacology studies in these models and have successfully executed multiple client sponsored studies.

Seventh Wave is the exclusive provider of services related to hepatitis B virus and C virus pharmacology studies using the humanized FRG® KO model. Yecuris’ models are highly repopulated with human liver cells, making them and ideal candidate for infectious disease and gene delivery/gene therapy studies:

Infectious disease: These models have been validated for hepatotropic disease, especially hepatitis. Please contact us to discuss additional applications in liver disease.

Gene Delivery/Gene therapy: We have demonstrated this model’s utility for evaluating gene therapy and gene delivery technology, evaluating expression using in vivo imaging.

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liver humanized FRG® KO mice

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Histology and Pathology Services

Price on request

All Seventh Wave pathologists are ACVP board certified and our service is fully GLP compliant. Seventh Wave pathologists have, on average, approximately 20 years of drug development experience.

We assign a pathologist to provide expert evaluation of your drug candidate whether your study is performed at Seventh Wave or at... Show more »

All Seventh Wave pathologists are ACVP board certified and our service is fully GLP compliant. Seventh Wave pathologists have, on average, approximately 20 years of drug development experience.

We assign a pathologist to provide expert evaluation of your drug candidate whether your study is performed at Seventh Wave or at another laboratory. The same pathologist can stay with your candidate, providing scientific continuity and consistency of evaluations throughout the life cycle of your compound.

Services Include:
- GLP Compliant processes, data and reporting systems
- Rapid and flexible scheduling, fast turnaround times
- Broad therapeutic expertise
- Primary review, Peer Review or both for all study types
- Necropsy participation
- Reporting

Histology Lab Services:
- GLP-compliant
- Robust QC and QA staffing
- Routine tissue trimming, paraffin embedding, and sectioning
- H&E staining
- Non-routine dissections and tissue harvesting
- Customized trimming and sampling
- Medical device support
- Serial sectioning and serial step sectioning
Special Histology and Pathology Services
- Frozen sections including serial and step sectioning
- Plastic embedding and sectioning
- Immunohistochemistry and immunofluorescence
- Image analysis (multiple platforms)
- Stereology (multiple platforms)
- Electron microscopy

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Hepatitis B Virus (HBV)-Infected Human Serum

Price on request
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Hepatitis B Virus (HBV)-Infected Human Plasma

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Animal Necropsy Services

Price on request

Necropsy
- On-site or remote necropsy
- Specialized perfusions and/or dissections
- Oversight by an ACVP-certified pathologist

Necropsy
- On-site or remote necropsy
- Specialized perfusions and/or dissections
- Oversight by an ACVP-certified pathologist

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Rabbit Mouse Pig Rat Dog

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Microscopy

Price on request

Our laboratory provides industry-recognized expertise in quantitative microscopy. Consultation and design-based techniques coupled with broad histochemical/immunohistochemical capabilities and knowledge of various disease states create the best possible quantitative evaluations.
Image Analysis:
- Computer assisted, high... Show more »

Our laboratory provides industry-recognized expertise in quantitative microscopy. Consultation and design-based techniques coupled with broad histochemical/immunohistochemical capabilities and knowledge of various disease states create the best possible quantitative evaluations.
Image Analysis:
- Computer assisted, high throughput capability
- Multiple image analysis platforms are used, including Visiomorph™ and Halo™
Stereology:
- Unbiased, design-based, using statistically proven principals
- Multiple stereology platforms are used, including NewCast™
Examples include:
- Muscle fiber cross-sectional area and Feret’s diameter
- Co-expression of markers; double-stain positivity in the cytoplasm or nucleus
- Area and area ratios; volume and volume ratios (e.g. volume of infarcted tissue, collagen, or mucus in an organ)
- Membrane marker quantitation
- Immune cells in tumors
- Object quantitation (e.g. microvessels, amyloid plaque, glomeruli, islets)
- Number of cells in a structure or organ
- Microglial activation
- Layer thickness
- Proliferation assays
Reporting:
- Interpretive reports with illustrative images are prepared by Seventh Wave Pathologists

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Visiomorph™ Halo™ NewCast™

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Immunofluorescence

Price on request
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Dermal Toxicity Studies

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Rabbit Mouse Pig Rat Dog Nonhuman Primate Oral Intravenous Subcutaneous' Dermal Buccal/sublingual Custom route development Show 10 more tags Show less

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Immunohistochemistry (IHC)

Price on request
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Image Analysis

Price on request
  • Computer assisted, high throughput capability
  • Multiple image analysis platforms are used, including Visiomorph™ and Halo™
  • Computer assisted, high throughput capability
  • Multiple image analysis platforms are used, including Visiomorph™ and Halo™
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Visiomorph™ Halo™

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Stereology

Price on request
  • Unbiased, design-based, using statistically proven principals
  • Multiple stereology platforms are used, including NewCast™
  • Unbiased, design-based, using statistically proven principals
  • Multiple stereology platforms are used, including NewCast™
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NewCast™

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Preclinical Study Design

Price on request

Our Consulting Services operate as an extension of your team to help design and execute an efficacious preclinical development program. Our exploratory preclinical safety evaluation approach identifies dose/exposure relationships for tolerability, as well as identification of organs and/or systems susceptible to adverse... Show more »

Our Consulting Services operate as an extension of your team to help design and execute an efficacious preclinical development program. Our exploratory preclinical safety evaluation approach identifies dose/exposure relationships for tolerability, as well as identification of organs and/or systems susceptible to adverse pharmacology or toxicology. The goal is to discover potential flaws in novel pharmaceutical compounds that limit their development prior to the investment of significant time and money.

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Biochemistry & Molecular Biology

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Clinical Laboratory Services

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Imaging & Spectroscopy

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Discovery Pathology

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Project Management

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Process Consulting

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Sequencing data in FASTQ

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Clinical and Anatomic Pathology

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Cells and Tissues

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Pharmacology & Toxicology

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Protein Services

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Immunostaining

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Clinical Research

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Data Services

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Protein Expression Visualization

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Animal Models and Studies

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Animal Models of Disease

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Computational Modeling

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Human Plasma and Serum

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Human Plasma and Serum Services

Human Plasma and Serum Services

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Human Biofluids

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Human Biofluids Services

Human Biofluids Services

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Human Biospecimens

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Human Biospecimens Services

Human Biospecimens Services

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Biospecimens

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Biospecimens Services

Biospecimens Services

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Drug Discovery & Development

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Drug Discovery & Development Services

Drug Discovery & Development Services

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Pharmacology

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Pharmacology Services

Pharmacology Services

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In vivo Toxicity Testing

Price on request

In vivo Toxicity Testing Services

In vivo Toxicity Testing Services

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Callie Celichowski

Business Development Manager

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