Bioanalysis in compliance with GCP/GCLP
The bioanalysis of PK samples from clinical trials needs to be performed using validated bioanalytical methods with adherence to the current ICH M10, EMA and FDA guidelines.
Lablytica supports the bioanalytical phase of clinical trials with an experienced team of Analytical Chemists, Responsible Scientists, as well as a Quality Assurance group. These analytical phases are performed in accordance with Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP) standards.
We have extensive experience in developing, setting-up and validating bioanalytical methods for human plasma and urine PK samples. We quantify both large and small molecules, ranging from traditional small molecule APIs, through peptides and antibody drugs, to oligonucleotides. We can transfer an existing, validated method, or we can develop an in-house method for your analyte from the start.
We are aware that there are unique challenges in every clinical trial and set up our analytical projects at Lablytica accordingly:
Phase I SAD/MAD dose escalation trials
In a Phase I Single Ascending Dose/Multiple Ascending dose clinical trial (SAD/MAD) the challenge is to have a bioanalytical method that functions well with a short time-to-result. The available time between the last sample being drawn in a cohort, and the reporting of QC checked results in time for the next safety meeting assessment, can be as short as 2-3 days. Lablytica is well equipped for these situations though our utilization of automation coupled with a large number of analytical instruments.
In a Bioequivalence (BE) clinical trial, the number of samples can be significantly higher than in other trials. The study samples are usually delivered in one shipment. The bioanalytical method, in this case, needs to support automation and a high sample throughput to provide accurate results as quickly as possible. Since regulatory authorities rely on bioanalytical data for a decision, thorough method validation and study sample analysis documentation is essential from the very beginning. Lablytica’s paper-free documentation system allows for quick and safe filing of all data related to a study phase.
Late Phase Studies
Once projects have reached Phase II/III, well-established bioanalytical methods are usually available. The unique challenge lies in coordinating the sample sending and reception from multiple sites in multiple countries. Sites do not always have experience in shipping PK samples and care must be given to the sample reception and organization part of the analytical workflow. Lablytica, which is located only a 20-minute drive from the Stockholm Arlanda Airport, is highly experienced and willing to assist clinics with this process.