MIC TESTING, API DEVELOPMENT AND FORMULATION
MIC (Minimum Inhibitory Concentration) testing. API Development and Formulation. Perfectus Biomed Group can test microbial contamination of pharmaceuticals. GLP Compliant
Effectively determine the antimicrobial activity of your experimental products using our high-throughput, cost-effective tissue models.
Over prescription and overuse of antimicrobials have contributed to rising levels of pathogens resistant to the current arsenal of antimicrobial products. Biofilms, composed of bacteria and/or fungi that have settled on a surface and secreted a protective matrix, also contribute to antimicrobial resistance.
A critical step in the drug-development process is antimicrobial effectiveness testing. At Perfectus Biomed Group, we give you the confidence that your lead candidates will perform well in clinical trials by assessing your products in our predictive models.
Our human skin models mimic clinical outcomes without the high financial and time costs of setting up a clinical trial. Perfectus Biomed scientists are sector leaders in the customization and adaptation of In vitro and Ex vivo studies. Our data is globally recognized by regulatory bodies and can be carried out to GLP as requested.
We offer a range of standard and customized test methods including, but not limited to, MIC testing to EUCAST standards, anti-infective efficacy, sterility testing, microbial limits testing, biocompatibility testing and bacterial endotoxin testing. We support your product through regulatory processes such as New Drug Application (NDA) submissions and Pre-IND applications.
Our reactors serve as a testing platform for drugs or devices against biofilms grown on abiotic surfaces. We can determine whether bacteria will grow to a biofilm in the presence of your materials.
Ex Vivo Human Skin Model
We perform research on human skin to test for efficacy against known human pathogens. We can provide antimicrobial effectiveness testing for products on both unwounded and wounded human skin models.
Ex Vivo Skin Model
Ex Vivo Mucosal Model (PMM)
The mucosal tissue serves as an optimal environment for the growing of pathogens. We test against either planktonic or biofilm infections in this model. This model functions as an antimicrobial efficacy litmus test to rapidly screen multiple experimental products.
Cell Line QC Testing
Cell line authentication and sterility testing are integral to world-class research and development in pharmaceuticals. We specialize in qPCR technology, screening for the presence of viral and bacterial pathogens, and STR profiling to confirm cell line identity.
Please contact us to discuss how we can support research and development programs related to pharmaceuticals and support your product through regulatory processes.
We are experts in:
- GLP testing
- Efficacy assessments
- Biocompatibility testing
- Planktonic bacteria
- Established biofilms
- Coculture assays
- Fungal/yeast cultures
- Spore forming cultures
- Anaerobic cultures
We have experience with:
- Reconstructed human epidermal models
- Human oral epithelium model
- Human corneal epithelium
- MIC determination
- MBEC determination
- Novel drug compounds
- Nanoparticle technologies
- Drug delivery systems
- Endotoxin testing