GLP Bioanalysis

GLP Bioanalysis

 

Agilux’s GLP bioanalytical services are all about delivering on our commitment consistently to meet program schedules and provide high quality data. Agilux combines itsGLP significant experience in quantitative LC-MS/MS Bioanalysis, innovative science, and efficient, validated processes to deliver quality data on time.


 

A Single Point of Control


Because your success is our top priority, an experienced Agilux Principal Investigator (PI) will be assigned to you.  Your PI will act as a consistent single point of control for all of your GLP programs at Agilux, and will direct his or her team in method development/transfer, validations, and all subsequent sample analysis.
We believe that direct access to a dedicated PI facilitates accurate and timely communication with our clients, and prompt response through actions in our laboratories.


For more information on our GLP Bioanalytical services, please see the details below and contact us at info@agiluxlabs.com.

 

View the GLP Bioanalysis Product Sheet.

 

GLP Bioanalysis

Agilux offers a broad spectrum of GLP bioanalytical services, including:

  • Method development, validation, and rapid transition of methods between species and      matrices according to current regulatory guidelines
  • Method transfer/cross validation utilizing quality controls and/or incurred study samples
  • Preclinical & clinical GLP sample analysis using LC-MS/MS
    • Clinical PK sample analysis
    • Bioequivalency studies
    • Therapeutic drug monitoring studies
    • Drug-drug interaction study support with validated, multi-analyte methods
  • Biomarker measurement using LC-MS/MS
  • GLP tissue analysis
  • Analyte stabilization techniques



Developing a robust analytical method within tight timelines is key to ensuring programs meet the project schedules. The PI team is supported in accomplishing this objective through application of an innovative, standardized approach to Method Development. Leveraging the power of LC-MS/MS in conjunction with the incorporation of a series of procedural and technical probes, your PI team gains increased efficiency in effectively troubleshooting and interpreting the results of method development experiments to create the optimal method quickly.

GLP Bioanalysis
At the conclusion of method development, Agilux conducts a thorough method pre-qualification prior to validation, in order to assess the method for precision and accuracy, specificity, matrix effects, and assay ruggedness.   Once the method has achieved the appropriate robustness, a detailed validation plan is submitted to the client prior to the commencement of the method validation. Rigorous technical review ensures that all validations are scientifically sound, and that they meet or exceed the regulatory requirements outlined in guidance documents such as the FDA's "Guidance for Industry, Bioanalytical Method Validations" issued in May, 2001.

 

 

 

GLP
Agilux offers substantial capacity and expertise in the highly sensitive and precise technique of LC-MS/MS bioanalysis. We have validated the quantitation of NCE drugs, metabolites, and biomarkers from a wide variety of biological matrices.  Rapid LC-MS/MS sample bioanalysis delivers reliable results on-time for any project, ranging from preclinical studies, through Phase I dose escalation studies, to large Phase II-III clinical programs. 

The laboratory is equipped with the latest instrumentation which includes AB Sciex API 5500 and API 4000 LC-MS/MS systems (10 total systems), Waters Acquity UPLC systems, Thermo Aria HPLC systems, and Hamilton Nimbus 96-Well sample processing systems. Watson LIMS is used for data management.

 

One of the keys to Agilux’s GLP business is a partnership of the Quality Assurance group with the staff and management of the GLP bioanalytical group.  The Quality Assurance group is an active voice in ensuring quality is built into the system from beginning to end. 

Agilux stays current with industry trends and initiatives by actively participating in numerous organizations such as: