Search

Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
GET IN TOUCH
Brochure

Comprehensive In-Vitro Microbial Kill Rate Studies for screening antimicrobial agents

Download PDF
Conducting in vitro time kill-rate studies with in-depth accuracy and precision is the most appropriate method for assessing the bactericidal or fungicidal impact of new or established drug candidates or other substances/materials, as well as for comprehending the dynamic relationship between antimicrobial agents and microbial strains. These studies also play an important role in evaluating the antibiotic component of combination products and to determine synergism or antagonism between drugs (two or more) in combinations.
 
Aragen Life sciences has established a dedicated, state-of-the-art lab for microbiological testing services equipped with all the modern equipment’s. We can expertly perform a range of microbiological assessment tests and have expertise in performing in vitro time kill-rate studies of range of products, including pharmaceuticals.
Capabilities:
  • Extensive comparison of antimicrobial property of
    Reference Listed Drug (RLD) vs Test product.
  • Extensive bactericidal or fungicidal assessment in
    time and concentration dependent manner.
  • Studies are conducted by using 12 replicates of each organism (18 organisms) as per USP<51> and indication section of RLD label.
  • Dedicated laboratory equipped with all the modern
    equipment.
  • Experienced microbiologists, well-trained in aseptic
    techniques and Good Laboratory Practices
  • Protocols for determining synergism or antagonism
    between drugs (two or more) in combinations.
  • Well documentation and validated test reports with
    professional photography
Role of Kill Rate Studies in the Regulatory
Approval Process:
  • Early Development and Screening: Library of
    compounds are screened and prioritized based on their
    inhibition potential.
  • Dose Selection: Results from these studies enable the
    researchers to estimate optimal dosage required for
    therapeutic effect in vivo studies.
  • Comparative Analysis: Demonstrating the efficiency of
    the new drug, providing valuable information for
    regulatory agencies to make approval decisions.
  • Resistance Development: Understanding how quickly
    resistance may emerge can influence dosing strategies
    and treatment guidelines to minimize the risk of
    resistance.
Process outline:

Designing a comprehensive study plan and parameter optimization: Method development and validation and main study with RLD and test product.

Method Development: Planned with single trial 18 organisms with reference listed drug.

Method Validation: Planned with three trial 18 organisms with reference listed drug.

Main Study: Planned with 12 trials, 18 organisms with reference listed drug.

Experience that counts:
  • Multiple studies have been conducted over the last 5 years.
  • Clientele – Companies (Pharmaceutical, Lifesciences, Healthcare, Agrochem, Medical devices, Cosmetic), all across the globe.

To know more about our capabilities and to speak with our subject experts write to us at bd@aragen.com.