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Pharmaceuticals and Biologics

Vipragen has been serving this sector with quality services of Pharmaceutical and Vaccine testing for over a decade with a wide range of tests, specifically focused on Biologicals as per the global guidelines and as per International pharmacopeia (ICH, USP, IP) for global market approvals.  The types of studies offered for IND, ANDA, and NDA submissions/filings for Biotech and Pharma companies are listed here.

As an END-To-END service provider for Pharmaceutical Sector, Vipragen is capable of providing robust Discovery services with an experienced group of passionate Drug Discovery Scientists to take it towards an entire process of Development. Vipragen has developed various Animal models to validate specific disease models widely ranging from Metabolic lifestyle disorders, wound healing, inflammation, oncology and Anti-bacterial composites.

Physico-chemical Properties

Metabolism

Protein Binding & Partitioning

In-Vitro Cytotoxicity

In-Vivo Pharmacokinetics

Bioanalysis

Toxicology (Safety) Services

Vipragen has embarked on safety screening as primary requirement for any preclinical package, as an expert in Repeat Dose and Reproductive Toxicology, Vipragen has performed innumerable Toxicity testing with various groups and multiple routes of administration.

Single Dose/MTD/6 Pack Studies

Include full battery of animal tests used to evaluate acute systemic toxicity by three routes of exposure, skin and eye irritation/corrosion, and skin sensitization.

Repeated Dose Toxicity (Subacute, Subchronic and Chronic)

Include standard Subacute, Subchronic chronic Toxicity Testing studies with full clinical pathology, necropsy and organ weights, as well as histopathology (either with full histopathology or limited tissue evaluation).

Genotoxicity

Include both invitro and invivo studies to determine potential carcinogenic/mutagenic compounds that can cause genetic alterations in somatic or germ cells and to determine the potential of DNA damage which can affect the chromosomal structure or disturb the mitotic apparatus resulting in variation in chromosome number.

Reproductive & Developmental Toxicity (DART)

Include Developmental and Reproductive studies in rodents (mice or rats) and rabbits to evaluate the potential effects on male and female reproduction and effects on development.

Note: In addition to these studies through the oral route, various tailor made studies, through dose administration routes like IV, SC, IM etc. and for various types of test items (Pharmaceuticals, Agrochemicals, Biosimilars, Nutraceuticals, Herbal etc…) can also be performed at Vipragen under GLP/ Non-GLP environment.

Analytical Chemistry

Include studies like physic-chemical, soil characterisation, residue, environmental fate and metabolism which are integral part of regulatory submission along with method development, characterisation and dose formulation analysis for test items.

Biologics and Biosimilar Testing

Vipragen has successfully evaluated about 10 Biosimilars for toxicological studies, Vipragen provides specific toxicology tests for Biologics, Biosimilars, Large Molecular analysis. A Seasoned testing CRO, Vipragen has partnered with many Biopharma Companies at different scales to handhold them for a smooth completion of the preclinical trials until regulatory submissions and beyond.

PCT Testing

Experience in handling Large molecules having expertise ranging from analytical method development to Toxicological Assessments.

Test for Batch Release

Vipragen performs a range of quality control testing requisitions to address the purity, concentration, consistency, identity and biosafety of products. The following tests are performed.

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