Submissions to the US FDA and DCGI
Pharmaceutical Microbiology Testing
Aurigene Pharmaceutical Services pharmaceutical microbiology testing department has a BSL-2 compliant lab and a dedicated in-vivo facility for bacterial and fungal infection murine disease models. The team has vast experience in anti-infective drug discovery projects and ran several collaboration projects with innovator pharma companies to discover anti-bacterial and anti-fungal agents. Established in-vitro time-kill kinetics bioequivalence assays for generic products for regulatory submission.
Why Aurigene Pharmaceutical Services for Pharmaceutical Microbiology Testing?
Highly Qualified & Experienced Scientists
Audited by the US FDA with Zero 483 in 2019
BSL-2 Compliant Microbiology Lab
In-vitro pharmaceutical microbiology testing services include:
- Pharmacodynamic studies: Drug-organism interaction
- MIC and MBC: Susceptibility indicators; major parameters used to quantify the activity of an antibacterial agent against the target pathogen
- Time kill kinetics: Information on the time course and rate of antimicrobial activity
- PAE and PA-SME: Information on persistent effects of antibacterial agents
- Resistance development and mutation frequency: Information on the rate of resistance
- Others: Antimicrobial combination/effect of serum proteins on MIC/ biofilm studies
Our dedicated Microbiology labs offer a wide range of infectious models that can be tailored as per customer requirements
In-vivo Pharmaceutical Microbiology Testing
- Systemic infection models: Acute lethal model to generate POC and determine ED50 - primary screening
- Respiratory tract infection models: Test efficacy of NCEs in highly vascularized tissue like lungs
- Thigh infection models: Test efficacy of NCEs in poorly vascularized tissues like thighs
- Urinary tract infection models: Testability of NCEs to clear UTIs
- Organ burden models: Testability of NCEs to clear the disseminated infection
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