Pharmacokinetics Assays
Pharmacokinetics (PK) is a crucial part of biopharmaceutical toxicology that evaluates the absorption, distribution, metabolism, and excretion (ADME) of biotherapeutics. Prolytix offers robust PK assays to support preclinical and clinical phases of biotherapeutic development.
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Pharmacokinetics is a critical component of biotherapeutic development that assesses drug exposure in the body over time and supports evaluation of safety and toxicology. PK assays are an essential early step in understanding how a biotherapeutic behaves in vivo.
Prolytix develops, validates, and conducts pharmacokinetics assays to support preclinical and clinical phases, as well as CMC programmes that help ensure large‑molecule biotherapeutics reach commercialisation efficiently.
All PK assays are conducted in Prolytix’s integrated GLP, GCLP, CLIA, and GMP bioanalytical facilities, which maintain an outstanding FDA and client inspection track record and are supported by more than 35 years of large‑molecule expertise.
Brochures
Process development, analytical development, and GMP testing and release services
Explore the analytical and bioanalytical services Prolytix provides to support large molecule drug discovery and development, from product characterization through GMP release. Capabilities include analytical method development, critical quality attribute testing, process development, stability testing, and bioanalytical assays such as pharmacokinetics, anti-drug antibody, neutralizing antibody, potency, and thrombin generation assays. Prolytix also offers GMP-compliant release testing and lifecycle management of critical reagents.
Resource details:
Resource type: Product brochure
Page count: 2
Read time: 3 mins
