Diverse Therapeutic Areas:

Our in vivo pharmacology team excels in various therapeutic domains.

Supporting Infrastructure:

AAALAC Accreditation: Our vivarium holds accreditation from AAALAC, ensuring high standards of animal care and use.

GLP Certification:

The vivarium is GLP-certified, adhering to good laboratory practices.

Capabilities and Services:

Customized Efficacy Models: Experienced scientists can design diverse efficacy models according to program or client specifications.

Target Engagement and Efficacy Models:

Offered for a range of therapeutic areas, including Oncology, Immuno-oncology, Metabolic disorders, Inflammation, Pain, Acute inflammation, Autoimmune disorders, Syngeneic tumor, Muscle regeneration, and Skin disorders.

Validation and Support:

Reference Compounds: Models are validated using reference compounds for reliability.

Histopathology Analysis:

Thorough histopathological assessments support model validation.

Biomarker Analysis:

Biomarker analysis provides additional insights and comprehensive data.

Cardiovascular and metabolic diseases stand as prominent contributors to mortality and disability in developed nations, while simultaneously emerging as a mounting concern in developing regions. Vipragen provides an extensive portfolio of services dedicated to drug discovery for cardiovascular and metabolic diseases. This encompasses cutting-edge platforms for target identification and validation, intricate in vitro and in vivo pharmacology models, and a robust foundation in chemistry and disease biology. These integrated services play a pivotal role in bridging the gap between fundamental research and clinical application.

Molecular Biology Services: A Diverse Range

Our team of scientists collaborates with biopharmaceutical companies dedicated to advancing cardiovascular and metabolic disease drug discovery programs. We offer a range of in vivo pharmacology models tailored for studying both metabolic and cardiovascular conditions. These include:

Nonalcoholic Steatohepatitis (NASH):

A model designed to study liver inflammation and damage associated with metabolic syndrome.

Diet-induced Obesity:

Models reflecting the impact of dietary factors on the development of obesity, providing insights into associated metabolic changes.

Type 1 Diabetes:

In vivo models capturing the pathophysiology of Type 1 Diabetes, aiding in the exploration of potential therapeutic interventions.

Type 2 Diabetes:

Comprehensive models to investigate the complexities of Type 2 Diabetes, facilitating the evaluation of drug candidates.

Fatty Liver Disease:

Models focused on understanding the mechanisms and progression of fatty liver disease, offering valuable data for drug discovery.

Dyslipidemia and Atherosclerosis:

In vivo models exploring the interplay between lipid metabolism and the development of atherosclerosis.

Vascular Inflammation:

Models dedicated to studying inflammatory processes within blood vessels, crucial for addressing cardiovascular conditions.

These models provide a robust foundation for biopharmaceutical companies to conduct targeted and effective research in the realm of cardiovascular and metabolic drug discovery. By integrating our meticulously characterized in vivo models with an extensive array of translational biomarkers, our collaborators gain the flexibility required to showcase the therapeutic effectiveness of their compounds.

Pharmaceutical Formulation Development Services in India

The production, supply, and analysis of high-quality dose formulations play a pivotal role in maintaining the integrity of any preclinical program and are crucial for the success of a study. Whether we are adhering to a formulation process provided by the client or implementing a procedure developed by our seasoned formulation development scientists, we prioritize the meticulous preparation and analysis of pharmaceutical formulations to ensure accuracy and appropriateness.

Preformulation Screening Through to Formulation Development

Achieving consistent bioavailability and formulation stability depends on selecting the right solid form. Our scientists use polymorph and salt screening, along with various solid form characterization techniques, to understand the physical properties of APIs (Active Pharmaceutical Ingredients). This aids in identifying suitable formulation strategies for enhanced exposure. We offer a comprehensive suite of formulation discovery and development activities, including preformulation investigations, screening, validations, stability assessments, compatibility checks, and dosing apparatus evaluations. Our globally distributed Analytical Chemistry groups, equipped with advanced instrumentation, support these services, ensuring a thorough approach based on a deep understanding of the drug's physicochemical characteristics.

Assessment of Clinically Relevant End Points

Successful drug discovery relies on selecting drug candidates exhibiting favourable in vivo pharmacokinetic properties, appropriate preclinical safety profiles, and robust data packages supporting on-target effects that can be evaluated across multiple animal models. Our Discovery Services group comprises adept technicians and scientists with extensive experience in major pharmaceutical and biotech companies, collectively shepherding numerous programs through the discovery process. We can steer your research towards a diverse range of potential analytical endpoints, including:

» LC-MS

» ELISA

» Immunoassays

» Chemistry and immunohistochemistry

» PCR

» Cell and enzyme-based assays and screening

» q-NMR whole-body composition

» Rodent activity and whole-body calorimetry

» Custom in vivo, in vitro, and ex vivo readouts

In essence, we provide a comprehensive suite of services designed to furnish you with a decisive go/no-go assessment for your Cardiovascular and Metabolic drug discovery programs.

The global health crisis, exacerbated by the absence of anti-infective compounds and vaccines reaching clinical proof-of-concept, underscores the urgent requirement for innovative infection strategies. In this intricate field, researchers must grasp the intricacies of pathogen and host biology. Our extensive array of infection models and proficiency in immunology and microbiology are instrumental in evaluating potential novel therapies and expediting the transition of molecules into clinical trials.

Preclinical CRO Infection Models

Vipragen specializes in infectious diseases, evaluating novel anti-infectives such as antimicrobials, antivirals, and vaccines. Our comprehensive approach involves diverse methods to understand disease, host interactions, and treatment effects. We employ in vitro infection assays, CFU, viral titre assessments, clinical parameters, and PD analysis for measurement. Our unique real-time in vivo bioluminescent imaging (IVIS) tracks disease progression and treatment impact. We offer a range of Gram-positive and Gram-negative species for customized PD models and translational human disease models. Early screening of infection compounds provides insights into toxicity and efficacy, facilitating optimal dosing regimens and combination therapy evaluation before murine model application

Bacterial Infection Models Offered:

Bacterial Thigh Infection: Assessment of bacterial impact in the thigh region.

Bacterial Sepsis: Evaluation of systemic response to bacterial invasion.

Bacterial Peritonitis/Sepsis: Investigation of peritoneal and systemic bacterial effects.

Bacterial Lung Infection (Acute/Chronic): Study of acute and chronic bacterial lung infections.

Bacterial Skin/Wound Infection: Examination of bacterial effects on skin and wound areas.

Bacterial Otitis Media (Acute): Analysis of bacterial impact on the middle ear in acute conditions.

Otitis Externa: Exploration of bacterial influence on external ear inflammation.

Urinary Tract Infection: Assessment of bacterial impact on the urinary tract.

Clostridium difficile Infection: Investigation of bacterial effects associated with Clostridium difficile.

Group B Streptococcus: Study involving the bacterial species Group B Streptococcus.

Bacterial Strains Offered:

Acinetobacter baumannii (A. baumannii): Inclusion of the A. baumannii strain, particularly known for multidrug resistance.

Escherichia coli (E. coli): Availability of E. coli strain, a versatile bacterium with various strains, including multidrug-resistant variants.

Klebsiella pneumoniae (K. pneumoniae): Incorporation of the K. pneumoniae strain, notable for its multidrug-resistant nature.

Pseudomonas aeruginosa (P. aeruginosa): Presence of the P. aeruginosa strain, recognized for its multidrug resistance.

Staphylococcus aureus (Methicillin-Sensitive and Methicillin-Resistant) (Staph. aureus - MSSA and MRSA): Inclusivity of Staph. aureus strains, both Methicillin-Sensitive (MSSA) and Methicillin-Resistant (MRSA).

Streptococcus pneumoniae (S. pneumoniae): Availability of the S. pneumoniae strain, contributing to the understanding of bacterial infections and resistance patterns.

Additional Bacterial Strains:

A diverse array of bacterial strains can be sourced through the American Type Culture Collection (ATCC).

Specialized Viral Infection Models:

Explore the efficacy of your anti-infectives, antivirals, and vaccines through specialized viral infection models, covering:

» Influenza

» Herpes Simplex Virus

» Respiratory Syncytial Virus

» Encephalomyocarditis Virus

These models provide valuable insights into the effectiveness of your interventions against specific viral pathogens.

Accelerate your immunology research with translational immunology assays and inflammation models designed to faithfully replicate the human immune system. Access comprehensive bioanalytical support within a robust platform, providing decisive data to expedite your therapeutic journey to clinical application.

Inflammation Models

In immunology research, understanding the immune system's role in diseases has expanded beyond conventional associations, encompassing various domains. Vipragen's experienced immunologists offer support for immunology initiatives through a range of in vivo and in vitro assays, inflammation models, and autoimmune models across therapeutic areas, including vaccine development, infectious diseases, and immuno-oncology. Their translational approach integrates relevant biomarkers, such as flow cytometry and histologic analysis, tailored to the specific objectives of immunology programs.

Challenges in Immunology Research

In immunology research, emerging immunomodulatory therapies target specific cell types and pathways in autoimmune and inflammatory diseases, preserving the overall immune response for improved patient outcomes. Effective drug discovery in inflammation and autoimmunity demands models closely replicating human target diseases. Choosing an efficacy model aligned with the therapeutic's target is essential for a comprehensive understanding of its effects. Pharmacodynamic models offer an alternative method to demonstrate in vivo target engagement before advancing to more complex efficacy models. With the rise of antibody-based therapies, it's crucial to consider cross-reactivity and conduct testing using relevant human immune cell populations. Vipragen's team provides a range of immunology assays and models to support comprehensive drug development efforts.

Vipragen excels in musculoskeletal research, offering specialized assessments of bone disease and quality. Their integrated service, combining expertise in discovery, preclinical program development, and advanced bone research technologies, enables comprehensive evaluations of drug impact at toxicological and pharmacological doses. The multidisciplinary team, including scientists, pathologists, veterinarians, and surgeons, ensures precise and efficient assessments of musculoskeletal drugs and devices, contributing to well-informed clinical trial designs. Vipragen's approach encompasses the evaluation of bone, muscle, and cartilage impact, along with assessing aspects like muscle tissue healing, biocompatibility, orthopaedic device efficacy, and novel Orth biologic applications.

Basic Research:

Understanding the musculoskeletal system and associated diseases relies heavily on research animal models. Vipragen provides critical models, including the Lewis Rat, SHRSP Rat, and transgenic mouse and rat models, to advance musculoskeletal disease research.

Discovery:

Musculoskeletal diseases, affecting millions globally, present chronic and debilitating conditions. Conditions like osteoarthritis or sarcopenia become more prevalent with age, posing higher risks for aging populations. Others, like muscular dystrophies, result from genetic mutations, impacting individuals early in life. Despite progress in molecular pathway understanding, challenges persist in assessing disease stage, progression, and efficacy in drug discovery. Vipragen accelerates discoveries through innovative target identification and validation, intricate in vitro and in vivo pharmacology models, and a robust chemistry and disease biology foundation. Comprehensive assessments incorporating pathology, imaging, and biomechanical strength testing are vital for evaluating a compound's musculoskeletal impact.

Safety Assessment:

Vipragen offers an integrated service in musculoskeletal research, featuring a multidisciplinary team of scientists, pathologists, veterinarians, and surgeons. This team provides technical expertise for accurate safety and efficacy assessments of musculoskeletal drugs and devices in both short- and long-term studies. The approach allows for a thorough evaluation of bone, muscle, and cartilage drug efficacy and safety, along with assessments related to muscle tissue healing, biocompatibility, orthopedic device efficacy, and the effects of novel orthobiologic applications.

General Support:

Vipragen's laboratory scientists utilize fully validated, networked data management systems across all locations for test article/item and sample management. Substantial investments in highly trained chemists, facilities, and instrumentation enhance capabilities and capacity for producing rapid, reliable, and high-quality data. Key services encompass formulation and analytical chemistry, bioanalysis through HPLC, LC/MS/MS, ELISA, and immunology.

Navigating the challenges and intricacies inherent in the quest for potential therapies for neurological disorders requires a nuanced approach. Our extensive neuroscience drug discovery services, coupled with our team's expertise, offer a foundation for tailored, inventive, and efficient solutions for your research endeavors. Our team of neuroscientists continually refines the most pertinent in vitro and in vivo models and assays for acute and chronic neurological diseases. This proactive approach assists our partners in the identification and testing of new compounds within this demanding field.

From In Vitro Models & Assays to In Vivo Pharmacology

The transition from in vitro models and assays to animal models is pivotal in comprehending the progression of neurological diseases while facilitating a comprehensive understanding of the candidate's pharmacokinetics and pharmacodynamics within an interactive physiology. Our well-established and reproducible in vitro models, along with in vivo pharmacology studies, have undergone validation for multiple assay platforms. These studies serve as reliable tools for screening a spectrum of compounds, ranging from small molecules to biologics.

Disease Areas

Neurodegeneration

» Alzheimer’s Disease

» Parkinson’s Disease

Pain

» Neuropathic Pain

» Chronic Joint Pain

» Inflammatory Pain

» Peripheral Neuroinflammation

» Nociceptive Pain

Rare Disease

» Amyotrophic Lateral Sclerosis

» Huntington’s Disease

» Batten’s Disease

» Duchenne Muscular Dystrophy

Psychiatric disease

» Autism Spectrum Disorder

» Schizophrenia

» Depression

» Anxiety

Brain Injury

» Spinal Cord Injury

» Stroke & Brain Ischemia

» Traumatic Brain Injury

Neuroinflammation

» Multiple Sclerosis

» LPS-induced

Tools for Advancing Neuroscience Discovery

Advancing the field of neuroscience discovery demands sophisticated translational tools, and our comprehensive suite of resources stands ready to meet these challenges. Through the application of phenotypic assays using diverse neuronal cellular and animal models, we offer robust solutions for uncovering novel disease targets and conducting high-throughput screens. Our commitment extends to unraveling the mechanism of action through the utilization of various imaging and electrophysiology modalities, providing a comprehensive understanding of drug actions. Additionally, our toolkit encompasses behavioral assessments and other biomarker methods, enabling the development of clinically relevant endpoints crucial for effective decision-making. These integrated tools collectively empower researchers to make informed and efficient strides in the complex landscape of neuroscience research.

Vipragen's wealth of experience in the development of ocular therapeutics spans from early discovery to safety assessment. This expertise allows us to assist clients in optimizing study designs and managing projects in a cost-effective and timely manner.

Animal Models of Ophthalmic Diseases

Vipragen provides validated disease models suitable for both non-GLP screening studies and more conclusive proof-of-concept studies. Additionally, we offer guidance on study designs for these models.

Methods of Administering Ocular Medications

• » Topical instillation
• » Intravitreal/subretinal injections
• » Subconjunctival/subtenon injections
• » Intracameral injections
• » Internal/external implants
• » Transplants (corneal)

 

Furthermore, we provide additional services to complement your ocular program, encompassing optical coherence tomography (OCT), electroretinography (ERG), tonometry (IOP), digital fundus photography, pachymetry (corneal thickness measurement), vitrectomy, quantitative autoradiography, drug metabolism, and enhanced microscopic evaluation. These supplementary services enhance the comprehensive assessment and understanding of ocular conditions, contributing valuable data to the overall research and development process.

Oncology Studies in India:

In oncology studies within in vivo pharmacology, diverse animal models, including xenografts and syngeneic models, play a crucial role in understanding various cancers and developing therapeutic interventions. Efficacy assessments involve meticulous evaluation of parameters like tumour growth inhibition and survival endpoints, providing insights into treatment effectiveness. Safety assessments examine potential toxicities, contributing to a comprehensive therapeutic profile. The translational aspect involves navigating the transition from preclinical research to clinical trials, addressing challenges and opportunities in applying findings to human applications.

Immuno-oncology studies in India:

In immuno-oncology studies, Vipragen explores the complex interplay between the immune system and cancer cells, focusing on checkpoint inhibitors and adoptive cell therapies. Combining traditional treatments with immunotherapies is pursued to boost overall efficacy, though this approach poses challenges. Biomarker analysis, utilizing techniques like immunohistochemistry and flow cytometry, is critical for assessing treatment response and predicting outcomes. Vipragen emphasizes the translation of preclinical immuno-oncology insights into clinical trials, addressing challenges in bringing promising immunotherapies to patient care.

Drug development for rare diseases follows a distinctive trajectory, mirroring the diversity among the numerous identified rare diseases. Yet, every triumph in the realm of therapeutics introduces novel technologies, methodologies, and understandings that have broader applications within the rare disease domain. The emergence of cutting-edge approaches, such as antisense oligonucleotide (ASO) and cellular therapies, brings promise to the 300 million individuals grappling with rare diseases, signifying a beacon of hope in the pursuit of effective treatments.

Strategies for Investigating Rare Diseases in India

Embarking on rare disease drug development requires a strategic and multi-faceted approach. Researchers and foundations dedicated to addressing rare diseases are adopting a multi-pronged and concurrent strategy to expedite the development of potential cures. To streamline the drug development process, scientists are employing cutting-edge technologies, evaluating diverse therapeutic modalities, and drawing insights from a range of sources to enhance efficiency and effectiveness.

Technologies for Rare Disease Studies in India

Platforms such as high-throughput screening (HTS), cell-based assays, and research models can be designed to mimic specific diseases using CRISPR and stem cells technology, providing more disease-relevant data for safety studies and translation to the clinic.

• » Research Models
• » Antisense Oligonucleotide Screening Services (ASO)
• » CRISPR
• » Stem Cells
• » High-Throughput Screening
• » High Content Imaging
• » Cell-Based Assays
• » Chemistry Services
• » In Vivo Pharmacology Models
• » Safety Studies

Approaches in Rare Disease Investigations The landscape of rare disease research is expanding, driven by technological progress in various methodologies, including therapies involving antisense oligonucleotides.

• » Small Molecules
• » Biologics
• » Gene and Cell Therapy

Vipragen excels in respiratory disease drug discovery, offering services from compound identification to safety assessments, including inhalation studies. Since 2005, our scientists have co-invented nearly 70 patents targeting respiratory indications and delivered 25 preclinical development candidates. Our in vivo pharmacology models cover asthma, acute respiratory distress syndrome (ARDS), chronic obstructive pulmonary disease (COPD), and pulmonary fibrosis. Working collaboratively, we select suitable animal models and translational biomarkers tailored to specific compound or program needs.

Available Models for Respiratory Disease

• » Asthma
• » Bacterial lung infection models
• » Influenza models
• » LPS-induced pulmonary neutrophilia model
• » Pulmonary fibrosis models