The pharmaceutical microbiology testing service at Aurigene is supported by BSL-2 compliant lab and a dedicated in vivo facility for bacterial and fungal infection murine disease models. Our team has collaborated on numerous anti-bacterial and anti-fungal agent discovery projects with innovator pharma companies. We have a dedicated team of scientists and allied staff with vast experience in anti-infective drug discovery projects. We have established in vitro assays and in vivo murine efficacy models.
We also support generic product filings through bioequivalance studies of in vitro time-kill kinetics against reference drug.
In vitro Pharmaceutical Microbiology Testing Services
- 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
- Others: Antimicrobial combination/effect of serum proteins on MIC/ biofilm studies
In vivo Pharmaceutical Microbiology Testing Services
- 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
Why Aurigene Microbiology Testing Services?
Submissions to the US FDA
Highly qualified & experienced scientists
Audited by the US FDA with Zero 483 in 2019
BSL-2 compliant microbiology lab
Wide range of infectious models & microbiology assay capabilities
Other Services
Virtual Tour
Hyderabad R and D Center
Bangalore R and D Center
Microbiology Testing
Connect with our scientific experts for your drug discovery, development, and manufacturing needs
We understand that clear communication is essential to successful collaborations, and that's why we have a dedicated team that is always ready to help you. Whether you have questions about our services, want to discuss a potential partnership, or simply want to learn more about our company, we're here to help.
Our team of experts is dedicated to providing personalised solutions tailored to your unique needs. So, please don't hesitate to reach out to us. We look forward to hearing from you and helping you achieve your business goals.
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Frequently asked questions
How does Aurigene Pharmaceutical Services customize in vitro microbiology services to meet specific drug development needs?
Aurigene Pharmaceutical Services tailors its in vitro microbiology services to meet the unique needs of drug development by employing a combination of advanced capabilities and customized approaches. These services encompass a variety of anti-bacterial and anti-fungal assays, including time-kill kinetics, MIC (Minimum Inhibitory Concentration), and post-antibiotic effect studies against diverse pathogens such as Staphylococcus aureus, Pseudomonas aeruginosa, and Escherichia coli. Additionally, the company utilizes murine infection models to evaluate the efficacy of drug candidates, with systemic and respiratory tract infection models approved by the IAEC. The microbiology department also conducts drug susceptibility tests according to CLSI guidelines, providing clients with vital data for regulatory submissions.
How do Aurigene's pharma microbiology testing services support regulatory submissions for generic products?
Aurigene's pharmaceutical microbiology testing services play a crucial role in supporting regulatory submissions for generic products by ensuring that these products meet the necessary safety, efficacy, and quality standards. The company conducts comprehensive microbiological evaluations, including sterility testing, endotoxin testing, and microbial limit testing, in accordance with regulatory guidelines such as USP, EP, and ICH. These services are essential in demonstrating that generic products are free from harmful microbial contamination and meet the prescribed limits for endotoxins and other microbial contaminants. Aurigene also provides thorough antimicrobial testing, including susceptibility testing to ensure the generic product's bioequivalence to the reference product. These microbiological assessments are integral to achieving regulatory approvals from agencies like the USFDA, EMA, and others, facilitating smooth market entry for generic pharmaceutical products
What distinguishes Aurigene Pharmaceutical Services' pharmaceutical microbiology testing CDMO services in terms of compliance and quality?
A"Aurigene Pharmaceutical Services' pharmaceutical microbiology testing CDMO services stand out due to their rigorous commitment to compliance and quality, ensuring the highest standards are met throughout the drug development process. The company operates under globally recognized quality management systems and holds certifications from regulatory bodies such as USFDA, EMA, and ISO 9001. Their microbiology testing services adhere strictly to guidelines such as USP, EP, and ICH, ensuring that all tests are conducted in compliance with international standards.
Aurigene's facilities are equipped with state-of-the-art instrumentation for sterility testing, endotoxin testing, and microbial limit testing, offering precise and reliable results. The company also ensures strict environmental control in its labs, maintaining the highest standards for contamination control, which is crucial for the safety and efficacy of pharmaceutical products. Additionally, the experienced microbiology team works closely with clients to ensure that their testing needs align with regulatory requirements, providing tailored solutions that support successful regulatory submissions"
How does Aurigene integrate in vitro and in vivo microbiology services to provide comprehensive testing solutions?
"Aurigene integrates its in vitro and in vivo microbiology services to provide comprehensive testing solutions that span the entire drug development lifecycle. The company combines advanced in vitro assays with robust in vivo models to assess the antimicrobial efficacy, safety, and pharmacokinetics of drug candidates.
In vitro services include a wide range of microbiological testing such as antimicrobial susceptibility testing, time-kill kinetics, MIC determination, and microbial limit testing. These tests are designed to evaluate the effectiveness of potential drug candidates against various pathogens in controlled laboratory settings, ensuring that they meet regulatory standards for safety and efficacy.
For a more holistic assessment, Aurigene integrates in vitro findings with in vivo testing. This includes using murine infection models to evaluate the pharmacodynamic properties, systemic distribution, and overall efficacy of drug candidates in more complex biological environments. The in vivo models, which include both systemic and localized infection studies, provide valuable data on the therapeutic potential of a compound in real-world biological systems, bridging the gap between laboratory testing and clinical applications.
This integration of in vitro and in vivo microbiology services enables Aurigene to deliver well-rounded, scientifically rigorous testing solutions that support the development of safe, effective, and regulatory-compliant drug products"
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