Bioanalytical Services for Small and Large Molecules
GLP and GCP bioanalysis services supporting all phases of drug development and non-GLP rapid discovery phase bioanalysis via state of the art facilities
AxisPharm is San Diego based bioanalytical LC/MS/MS service provider with more than 25 years experience in the field.Our Bioanalytical Chemistry Department specializes in developing and validating robust bioanalytical methods for PK/TK sample analysis of small molecules, proteins, peptides, and metabolites using LC/MS/MS (HPLC, UPLC, on-line SPE), HPLC/UV, and HPLC/FL. We have experience analyzing API and metabolites in various biological matrices and can provide bioanalytical support throughout all the stages of drug development.
- Method development
- GLP method validation
- Method transfer
- Early discovery bioanalysis (non-GLP)
- GLP sample analysis
- Clinical sample analysis
- Discovery PK studies
- Toxicokinetic studies
- Pharmacology studies
- Clinical studies (Phase I-IV)
- Tissue distribution studies
- Drug-drug interaction studies
- BA/BE studies
AxisPharm Labs is well equipped with all the necessary tools and instruments to perform all types of in vitro test, such as liver microsome metabolic stability, protein binding, pre-formulation and formulation stability, degradation monitoring, and so on. To carry out in vitro test for our customers, we need the customer to provide minimal 1 mg of the target compound as well as the protocols for the in vitro experiment.
Our lab can perform all the sample treatment procedures including protein precipitation, solid phase extraction, and liquid-liquid extraction.
To submit PK samples, we will need the following items included in the package:
- At least 1 mg pure compound
- About 1 ml formulated solution that is the same as used for animal administration (esp. for none PO delivery)
- At least 2 ml blank serum or biological fluid the same type as the samples
- At least 100 µl sample amount for each sample
Metabolite studies are like structure elucidation. Our data dependent LC/MSn and Data Dependent Scan techniques allow us to acquire up to five generations of ions, i.e. parent ion to daughter ions to grant daughters and so furth, to establish an extensive “family tree”. Although ultimate confirmation of the metabolite structure requres synthesis or the suspected structure, our MSn methods do give very relable suggestion of the final structure. More importantly, the tentative structure found by MSn is mostly sufficient for PK driven SAR in the discovery stage.
PK driven SAR has become the new trends for lead optimizations. More and more companies are including a PK team within their medicinal chemistry division. However, the time and cost for initiating and maintaining such a program can be very costly that may not feasible at all for a small company. At AxisPharm, we can function just like your own pre-clinic PK team at a small fraction of cost compare with building such as team in house. Our expertise, experiences, and instrumentation are all within your reach.
Partnered with a group of highly experienced pharmacologist, we provide complete package for your animal studies, efficacy tests, and disease models.