Eurofins’ Analytical Support Helps Biopharma Organizations Navigate Clinical Trials

Jon S. Kauffman, Ph.D., Senior Director, Eurofins Lancaster Laboratories Biopharmaceutical Services,JonKauffman@eurofinsUS.com

Regulatory agencies throughout the world have the responsibility of protecting public health by assuring the safety and efficacy of bio/pharmaceutical products and medical devices. Clinical trials are a critical and essential activity of the drug development process for gaining "medical knowledge" of these products.Therefore, it is incumbent upon biopharmaceutical organisations to sponsor clinical trials in order to demonstrate safety and efficacy to the regulators. Clinical trials require a tremendous amount of analytical testing, which is often outsourced to Contract Research Organisations (CROs).  Eurofins BioPharma  Services supports biopharmaceutical clients with a wide array of testing services that cover many aspects of clinical trials.

Eurofins Central Laboratory provides information on the response of patients enrolled in clinical trials through the testing of blood, urine, etc. The Central Lab offers the synergy of integrated safety assessment, biomarkers, therapeutic drug monitoring, genomic testing, and microbiology. This Lab performs a comprehensive menu of routine and customised safety and efficacy tests, including biochemistry, hematology, urinalysis, flow cytometry and many more to support clinical research
programmes of any size and complexity.

Eurofins BioPharma Product Testing focuses on another aspect: the biopharmaceutical products themselves used
in the clinical trials. Well characterised, representative products must be available for the trials. The BioPharma Product Testing laboratories offer a wide array of testing services to support sponsors throughout the clinical trial process. This lab transfers or develops and validates analytical methods to ensure the potency, purity and stability of clinical materials, including the drug products and raw materials used to manufacture them. Further, some study protocols require that tablets and capsules are overencapsulated in order to "blind" them to the patient and sometimes the physician (double blinded).

Eurofins BioPharma Product Testing provides extensive  testing that must be done in order to show the product release profile is consistent with the "virgin" product. This is a common approach in comparator product testing.  Before clinical trial materials are administered to patients, the team performs extensive stability and release testing under cGMP.

In this issue, you can read many other examples about how Eurofins BioPharma Services supports global clients' clinical diagnostic testing needs, including news from Eurofins Genomics, Boston Heart, Viracor-IBT, Eurofins Bioanalytical Services and Eurofins Lancaster Laboratories Professional Scientific Services.