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Calvert Laboratories, Inc.

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Scott Township, Pennsylvania, US

About Calvert Laboratories, Inc.

Calvert Labs is a preclinical CRO offering a wide range of lead identification, lead optimization and preclinical services, while providing clients with scientific guidance, regulatory excellence and customized study designs. For over 40 years, we have been partnering with clients to help them strengthen their... Show more »

Calvert Labs is a preclinical CRO offering a wide range of lead identification, lead optimization and preclinical services, while providing clients with scientific guidance, regulatory excellence and customized study designs. For over 40 years, we have been partnering with clients to help them strengthen their pipelines and develop the next generation of therapeutics aimed at improving and extending human life.

To date, Calvert Labs has made significant contributions to numerous IND and NDA applications, many which are now commercially marketed therapeutics. Our team has a collective 150+ years experience in various regulatory agency submissions globally, where none of our studies have ever been rejected for reasons of design or technical performance. Our experience and proven track record span over virtually all therapeutic areas and drug categories, ensuring a continuum of value to the changing needs of your business.

We’ll work with you through every step of each phase of early-stage drug development – starting with discovery and proceeding through the design and performance of preclinical studies to launch you into clinical development.

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Certifications & Qualifications

AAALAC DEA Schedule II DEA Schedule III DEA Schedule IV DEA Schedule V FDA Inspected GLP USDA

Our Services (31)


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IND/NDA/BLA Submission

Investigational New Drug/New Drug Application Submission
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Dermal Toxicity Studies

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Hamster Guinea pig Mouse Rat

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PK/PD Data Analysis

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Calvert can perform your initial PK screening and evaluate different dose formulations. Your custom designed study can be conducted in mice, rats, rabbits, dogs, pigs, and non-human primates using virtually any route of administration. Our standing colonies of non-naïve Beagles and Cynomolgus monkeys are available for studies... Show more »

Calvert can perform your initial PK screening and evaluate different dose formulations. Your custom designed study can be conducted in mice, rats, rabbits, dogs, pigs, and non-human primates using virtually any route of administration. Our standing colonies of non-naïve Beagles and Cynomolgus monkeys are available for studies requiring rapid turnaround at lower costs than studies using naive animals. Analyses of toxicokinetic data derived from the dose levels used in animal toxicity studies are provided to our clients in supplemental reports.

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In vivo PK/PD Studies

Price on request

Calvert can perform your initial PK screening and evaluate different dose formulations. Your custom designed study can be conducted in mice, rats, rabbits, dogs, pigs, and non-human primates using virtually any route of administration. Our standing colonies of non-naïve Beagles and Cynomolgus monkeys are available for studies... Show more »

Calvert can perform your initial PK screening and evaluate different dose formulations. Your custom designed study can be conducted in mice, rats, rabbits, dogs, pigs, and non-human primates using virtually any route of administration. Our standing colonies of non-naïve Beagles and Cynomolgus monkeys are available for studies requiring rapid turnaround at lower costs than studies using naive animals. Analyses of toxicokinetic data derived from the dose levels used in animal toxicity studies are provided to our clients in supplemental reports.

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Immunology Animal Models

Price on request

Earning a pristine reputation through global work with clients, competitors, governmental and regulatory agencies, Calvert Immunology Services continually enhances this reputation through the breadth and scope of studies we perform or design.

For over 40 years Calvert Labs has helped clients succeed in reaching significant... Show more »

Earning a pristine reputation through global work with clients, competitors, governmental and regulatory agencies, Calvert Immunology Services continually enhances this reputation through the breadth and scope of studies we perform or design.

For over 40 years Calvert Labs has helped clients succeed in reaching significant milestones along the development pathway. Calvert Labs offers comprehensive immunology services for both screening and efficacy disease models. Our Immunology Services Group works closely with each sponsor to develop protocols to address all scientific issues. For a comprehensive listing and to discuss your program requirements, please contact us.

Calvert Labs' Immunology services include, but are not limited to:

IMMUNOMODULATION ASSAYS

  • Mitogen-Induced Proliferation
  • Delayed-Type Hypersensitivity (DTH) Response to Oxazolone
  • Delayed-Type Hypersensitivity (DTH) Response to Ovalbumin
  • Mixed Lymphocyte Response (MLR) Assay
  • Hemagglutination Assay for the Determination of the Antibody Response to SRBC
  • T-Dependent Antibody Response to KLH
  • Natural Killer (NK) Cell Cytotoxicity Assay
  • Macrophage Phagocytosis Assay
  • Enumeration of Peripheral Blood Lymphocytes

INFLAMMATION/AUTOIMMUNE DISEASE MODELS

  • Developing Collagen-Induced Arthritis (CIA) Model in Mice
  • Established Collagen-Induced Arthritis (CIA) Model in Mice
  • DDS-Induced Colitis in Mice
  • TNBS-Induced Inflammatory Bowel Disease (IBD) Model in Rats
  • Experimental Autoimmune Encephalomyelitis (EAE) Model in Rats
  • Experimental Autoimmune Encephalomyelitis (EAE) Model in Mice
  • Streptozocin-Induced Diabetes Model in Rats
  • Streptozocin-Induced Diabetes Model in Mice
  • NOD Mouse Diabetes Model
  • Antigen-Induced Pulmonary Inflammatory Cell Accumulation (An Asthma Model)
  • Lipopolysaccharide (LPS)-Induced Model of Adult Respiratory Distress Syndrome (ARDS)

ANTI-TUMOR MODELS

  • Human tumor Xenografts in Nude Mice
  • MCF7: Breast adenocarcinoma
  • N417: Small cell lung carcinoma
  • H69: Small cell lung carcinoma
  • A549: Lung carcinoma
  • U87MG: Glioblastoma
  • AsPC-1 : Metastatic pancreatic adenocarcinoma
  • LVCaP – Prostate carcinoma (or any other cell line that is available and will grow in nude mice)

ANTI-INFECTIVE MODELS

  • Anti-Infective Protection Assay in Mice Against:
  • Methicillin Resistant Staphylococcus aureus (MRSA)
  • P. aeruginosa
  • Vancomycin Resistant Enterococcus faecalis (VRE)
    • NOTE: Other bacterial strains can also be used. However, a virulence assay may need to be performed prior to running the study.
  • Protection Assay Against an Acute Fungal Infection with Candida albicans in Mice
  • Thigh lesion Model in Mice

IMMUNOTOXICOLOGY

  • T-Dependent Antibody Response to KLH
  • Natural Killer (NK) Cell Cytotoxicity Assay
  • Macrophage Phagocytosis Assay
  • Enumeration of Peripheral Blood Lymphocytes

SENSITIZATION/ANTIGENICITY MODELS

  • Local Lymph Node Assay (LLNA)
  • Systemic Anaphylaxis Assay in Guinea Pigs
  • Passive Cutaneous Anaphylaxis in Rodents
  • Induction of a Delayed-Type Hypersensitivity (DTH) Response by a Test Article
  • Popliteal Lymph Node (PLN) Assay

BLOOD COMPATIBILITY STUDIES

  • Hemolysis Assay in Whole Blood
  • Flocculation Assay in Plasma and Serum

ELISA/RIA ASSAYS

  • Cytokines
  • Hormones
  • Others on request
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Toxicology

Price on request

Calvert Labs' toxicology team has a wide range of experience in the safety assessment of pharmaceuticals, biotechnology products, chemicals and select medical devices. In addition to standard study designs, we routinely work with clients to develop customized studies and screening programs. Our senior study directors directly... Show more »

Calvert Labs' toxicology team has a wide range of experience in the safety assessment of pharmaceuticals, biotechnology products, chemicals and select medical devices. In addition to standard study designs, we routinely work with clients to develop customized studies and screening programs. Our senior study directors directly oversee our clients’ studies and work collaboratively with senior management, technical staff and clients to ensure program goals and study objectives are achieved.

Calvert Labs toxicology services include, but are not limited to:

ACUTE

  • Acute Single Dose Toxicity
  • Primary Dermal Irritation
  • Primary Eye Irritation
  • Delayed Contact Hypersensitivity (Buehler Assay)
  • Maximization Sensitization Test
  • Venous, Perivenous Irritation
  • Hamster Cheek Pouch Irritation
  • Vaginal/Penile Irritation
  • Phototoxicity and Photoallergy
  • Comedogenicity
  • Wound Healing

SUBCHRONIC/CHRONIC

  • Dose-Range-Finding Toxicity Studies
  • Repeat-Dose Toxicity Studies

CARCINOGENICITY

  • Two-Year Carcinogenicity Studies

REPRODUCTIVE/DEVELOPMENTAL

  • Fertility and General Reproductive Performance (Segment I)
  • Embryo-Fetal Development or Teratology (Segment II)
  • Peri- and Post-Natal Development (Segment III)
  • Single and Multiple Generation Studies
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Safety Pharmacology

Price on request

Calvert’s pharmacology group has been recognized as a leader in both Safety and Discovery Pharmacology services since 1969. Our pharmacologists specialize in the customization of lead development and lead optimization strategies and have extensive experience in the design, execution and interpretation of pharmacology studies. We... Show more »

Calvert’s pharmacology group has been recognized as a leader in both Safety and Discovery Pharmacology services since 1969. Our pharmacologists specialize in the customization of lead development and lead optimization strategies and have extensive experience in the design, execution and interpretation of pharmacology studies. We have a history of developing novel models from published literature and client requests and are highly experienced in validating on site sponsor derived methodologies.

You can join our partners who have successfully licensed products in fields such as Inflammation/Analgesia, Cardiovascular Disease, and Diabetes.

Calvert Labs' pharmacology services include, but are not limited to:

SAFETY PHARMACOLOGY ICH S7A (Core Battery Tests):

  • Neuropharmacological Profile (NPP) in Mice or Rats
  • Effect of a Test Article on Respiratory Function in Mice or Rats
  • Evaluation of Cardiovascular Function in Conscious Telemetered Beagle Dogs or Non-Human Primates

SAFETY PHARMACOLOGY: ICH S7B

  • Preliminary Screenings (Non-GLP)
    • Anesthetized QT dog/guinea pig/rabbit
    • Purkinje Fiber
    • hERG Assay

GLP Safety Pharmacology

  • Anesthetized dog, guinea-pig and rabbit
  • Canine or rabbit Purkinje Fiber
  • Methoxamine QT Prolongation and TdP in rabbits
  • hERG Assay
  • Telemetry QT in dog or non-human primates

Secondary CNS Tests

  • CNS Neurotoxicity (Rotarod) Assay
  • PTZ Induced Seizure Assay
  • Submaximal Electroshock Seizure Assay
  • Barbiturate Sleep Time Potention Assay
  • Spontaneous Motor Activity

GI and Renal Assays

  • GI Propulsion/Gastric Emptying Assay
  • Urine Volume and Electrolyte Excretion Assay
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DART Studies

Developmental and Reproductive Toxicology Studies
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Hamster Guinea pig Mouse Rat

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IND-Enabling Studies

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Hit to Lead and Lead Optimization

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Hit Identification

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Non-Human Primate Models

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Drug Target Identification

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Regulatory Affairs Services

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ADME/DMPK Studies

Drug Metabolism and Pharmacokinetics
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Mammalian Models

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Oncology Animal Models

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Respiratory Disease Animal Models

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Animal Models of Disease

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In vivo Drug Efficacy Testing

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Animal Models and Studies

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Lead Identification and Validation

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Drug Discovery & Development

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In vivo Toxicity Testing

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In vivo Toxicity Testing Services

In vivo Toxicity Testing Services

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Project Management

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In vitro ADME/DMPK Studies

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Drug Discovery

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In vitro Cardiotoxicity Screening

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Premarket Approval Application

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Model Organisms

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hERG Channel Inhibition Assay

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