Pharma Laboratory Testing
Safety First – Unparalleled in our Industry
As your dedicated central laboratory, our results may comprise the majority of all data submitted in a NDA. We fully understand the necessity and importance of harmonizing our laboratory facility operations to ensure that all results generated via any of our laboratories around the world can be easily and seamlessly combined.
Utilization of global standard operating procedures, uniform instruments, reagents and analytical methods for safety testing enable the use of global reference ranges, resulting in uniform laboratory data that is completely combinable.
We put in every effort to secure the highest level of standardization by managing our central safety laboratory operations in the United States, Europe, Singapore, and China in the most appropriate and efficient way. Our high level of standardization removes all hurdles associated with collecting and integrating laboratory data versus local laboratories with low or no level of standardization, using different methodologies, reference ranges and or operating procedures.
Biomarkers in Clinical Trials
Eurofins Central Laboratory is uniquely positioned with its Biomarker Services by uniting GCLP and GCP in one synergetic approach. Our hybrid system allows us to combine best of two worlds when utilizing laboratory biomarkers to prove safety and efficacy, support go/no-go decisions, stratify patients and to support the submission of data sets to regulatory agencies worldwide.
Supported by a strong & experienced Scientific Affairs Committee, biomarker assays are developed and/or validated fit-for-purpose to meet the specific requirements of the Clinical Trial Program. As our Biomarker Services are fully integrated in our Central Laboratory, we offer a seamless transition to a production testing environment as any biomarker assay is evaluated for its feasibility as well. The combination of highest standards of quality and logistics, cutting edge technology and a tailored approach makes our biomarker services unique and extremely powerful.
Flow Cytometry
Globally harmonized Flow Cytometry capabilities are available in all 4 Eurofins Central Laboratory test facilities. Platforms include:
- FACSCanto™ (BD)
- FACSLyric™ (BD)
- FACS & Lyse automate
- FACS prep station
In addition, in our greater Eurofins BioPharma Services group, Eurofins Bioanalytical Services has over 20 years of experience in flow cytometry custom assay development, assay validation, and sample processing, and we offer you a sophisticated consultant and service solution for a wide variety of applications.
PBMC Processing Network
Eurofins Central Laboratory Shanghai is member of the larger Eurofins BioPharma Services, Laboratory Testing division with 18 locations globally that comprise our core PBMC network which allows standardized processing, regardless of clinical trial site location. In addition, for those specimens/ protocols with rapid PBMC processing requirements, we have the ability to utilize the complementary PBMC network of wholly owned Eurofins BioPharma Services laboratory globally.
18 active global locations, PBMC experienced Laboratory Technicians and downstream analytical capabilities
- Can provide 24 TAT from point of collection to processing, from most global site locations
- Eurofins Standard PBMC processing protocols
- Ficoll Pacque Method
- CPT Mononuclear Cell Preparation Tube
- Accuspin PBMC Isolation Tube
- Eurofins Standard PBMC processing protocols
- 15 different Sponsor defined processing protocols
- Variation in:
- Window of processing
- Collection techniques
- Washing steps
- Specialized stabilization media
- Variation in:
- Can incorporate Sponsor defined PBMC processing protocol via laboratory/technician qualification, including cellular viability
For 24 hours TAT requirements, all PBMC shipments are expedited, we verify at the onset of any project the exact times when PBMC isolation may be required, and we request site communication so that we can ensure adequate staffing ahead of time.
For < 24 hours TAT requirements, we utilize either a Train the Trainer model, where we provide training/oversight at the local clinical trial site level, or we deploy our Travelling Laboratory Technicians to the sites, to perform the qualified and harmonized PBMC stabilization. The latter service is provided currently for Testicular Toxicity protocols, which have stability TAT criteria of 45 minutes.
Esoteric Testing
In support of domestic testing in China, Microbiology, Pathology, Genomics and Bioanalytical testing services are offered by deploying qualified third party laboratory partners. We take full responsibility for the performance and output of the third party laboratories required, including data results. Data results would be incorporated into our cumulative “Data Lake” model, and presented as one comprehensive data transfer to our Clients.
