Bioanalytical, Preclinical, Clinical

We provide bioanaytical methods development, validation and sample analysis in our FDA-GLP registered facility in Bristol, CT. We support all types of preclinical studies from early discovery (ADME, PK, TK) through long-term chronic in all species. Pine Lake Labs Research group has many years of methods development experience in complex matrices such as brain, spleen, spinal cord and vaginal tissue, in addition to the traditional matrices of blood, plasma and urine.

-Preclinical and Clinical Bioanalysis

-Method development and validation

-Plasma, blood, serum, synovial fluid, urine, and feces

-Tissues: Liver, Kidney, spleen, brain, spinal cord, heart, eye, muscle, dermis

-Species: non-human primate, rodent, canine, porcine, bovine, and human

-Validation according to FDA guidance

Pine Lake Laboratories can perform these tests to the cleaning limits proposed by the client. If the medical device is at risk for a large number of residual processing agents, Pine Lake Laboratories recommends using a worst case scenario cleaning limit in the cleaning validation. A more detailed description can be found in the Technical Library.

Analytical Instruments

-Small and large molecules, oligonucleotides and aptamers

-Liquid-Liquid extraction, solid phase extraction, protein precipitation, digestion

-UPLC-MS/MS, Waters UNIFI software

-Watson LIMS

Capabilities:

Sample data is processed and reported using Watson LIMS software. All reports are delivered as “Ready to file” documents. We also offer full API characterization as well as formulation concentration and stability analysis.

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