Drug development services
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Out of 1500 molecules studied:
- 99% passed the analytical test
- 52% were selected for the development phase (F> 20%)
Biosimilars
- Study design
- Pre-clinical and clinical studies
- In-house method development and validation for Ab titres, ADA and NADA
- Calculation of PK parameters (WinonLin)
- GLP/GcLP compliant
- CDISC/SEND formats
ADME studies
- 14C/3H radiolabelled or cold compounds
- Blood/plasma kinetics, PK analysis
- Excretion evaluation, Mass balance
- Tissue distribution
- Biliary excretion
- Metabolite profiling
- GLP compliant
In-vitro metabolism
- Hepatocyte metabolism
- Microsome metabolism
- Protein binding
- Metabolite profiling
Immunogenicity
- Immunoassays and assessment of potential immunogenicity
- Anti-vaccine antibody titres
- In-house development and validation (FDA and EMA Guidelines)
- ADA Screening assay and ADA Confirmatory assay
- ADA Neutralising assay, cell culture facilities
- Reagent preparation
- GLP/GcLP compliant
ADC (Antibody Drug Conjugates)
- ADC (Antibody-Drug Conjugates)
- tADC and tMAB analysis by ELISA/ECL
- Payload analysis by LCMSMS
- ADA assessment
- All analyses in the same laboratory on the same sample
- From early stage to clinical trials
- In-house preparation of conjugates for bio-analysis
- GLP/GcLP compliant
Veterinary product development
- Exploratory Pharmacokinetics
- Small molecules/Large molecules/Biologicals
- Bioequivalence, all species (production and companion)
- Residue depletion studies in all production species
- In-house method development – all matrices
- Topical product development
- Validation to VICH Guideline 49
- Immunogenicity
- GLP compliant
