CEBIPHAR provides you with dedicated support in Microbiology studies:
- Microbiological antibiotics titrations (microbiological assay of antibiotics by diffusion): Development, validation and transfer of specific and robust methods:
- Routine testing of more than 14 antibiotics (3,500 samples / year – Drug Substances and Drug Products)
- Different designs and methods available (Latin square 6×6, 8×8, 9×9 / Petri dishes / Wells, discs and cylinders)
- Experience with complex matrices such as orthopedic cements, semi-solid dermatology formulations and oily suspensions
- Validation design according to ICHQ2 and VICHGL1&GL2 Guidelines
- Troubleshooting on customer site
- Optimization of your methods to reduce the occurrence of OOS
- Regulatory advice to support dossier variations
Our teams can successfully contribute to your project thanks to:
- The dual skills (Microbiology and Chemistry) of the operational teams
- Validation and statistics experts involved in validation protocols and customer discussions
- Our latest generation of automated equipment:
- Plate reader, automatic cutting system for wells, dilution and distribution, microplate reader, PSM, incubators, microscope, automatic inoculator, autoclave
Minimum inhibitory concentration (MIC) and minimum bactericidal concentration studies (MBC)
Determination of the Minimum Inhibitory Concentration (MIC) and Bactericide (CMB) of Antibiotics with respect to different strains (non-exhaustive list):
- Pseudomonas aeruginosa
- Staphylococcus pseudointermedius
- Mallasezia Pachydermatis
Our approach:
- The range of concentrations tested is defined in consultation with the customer
- Analyzes performed by the micro-dilution method in microplates according to the recommendations of EUCAST
- (European committee on antimicrobial susceptibility testing) and CLSI (Clinical and laboratory standards institute)
- For each MIC study, a positive and negative control is carried out.
- When applicable (data available in the guidelines), a positive quality control is carried out for each serie
- The concentrations of the bacterial suspensions used are checked by spectrophotometry and counting
Supply of a field strain banks
Collection of field strains via the veterinary studies department of CEBIPHAR
- Extension of the continuity of strain collections:
- Subculture of each strain in order to make a new cryotube bank.
- For each strain, a check of purity and identity is carried out for the new bank
- Storage of cryotubes at -80 ° C
- Shipment of strain banks by secure transport
CEBIPHAR also proposes the implementation of relevant synergies for microbiology services with ACM Pharma, a sister company of TERANGA groupe
