Packages

Work Package 10

Central Laboratory Services

Involves Partners ZYMX and Unilabs

Objectives:
This WP will perform all central clinical analyses of samples obtained during the clinical trials including bioanalysis, biomarkers, antibody screening, routine safety analyses, tailor-made study materials, sampling kit management, courier management, dry ice supply and long-term sample storage.

Description of the Work:
The clinical Trial laboratory work will be performed in accordance with GCP/ICH guidelines. Unilabs holds an ISO 17025 accreditation for: Special clinical biochemistry and haematology, coagulation, and endocrinology. In addition Unilabs holds a “Statement of GLP Compliance” from the Danish Medicines Agency. Besides the analytical work Unilabs will perform data cleaning and report the analytical results from all laboratories electronically when the trial is finalized. The work will include study set-up, sample monitoring, data cleaning, data transmission, shipment and transportation of frozen samples.
An assay for the determination of rhLAMAN and of serum anti-rhMannosidase antibodies will be developed, optimized, and validated in accordance with current regulatory guidelines. The methods will be an “Enzyme-linked immunosorbent assay” (ELISA). Micro-Titer-Plates will be read by means of a microtiterplate photometer, ANTHOS HTII. The validations will be documented in validation reports.
The analysis will be performed in a GLP environment and all samples from one subject will be analysed at a time, if possible in order to minimize the intra-individual coefficient of variation. Micro-Titer-Plates will be read by means of a microtiterplate photometer, ANTHOS HTII. The analytical results will be reported electronically as well as in a Bio Analytical Report, according to current regulatory guidelines.

The following components will be determined in blood by means of an auto analyzer PENTRA DX120:

Haemoglobin (Hgb)
Erythrocyte sedimentation rate (ESR)
Erythrocytes (RBC)
Platelets (PLT)
Mean cell volume (MCV)
Mean cell haemoglobin concentration (MCHC)
Mean cell haemoglobin (MCH)
White blood cells (WBC).

The following components in serum or plasma will be determined by means of an auto analyzer ADVIA 1650:

Alanine Aminotransferase (ALAT)
Aspartate Aminotransferase (ASAT)
Alkaline Phosphatase
Amylase
Bilirubin (total)
Calcium (Ca)
Creatinine
Creatine kinase (CK)
Potassium (K)
Sodium (Na)
Lactate dehydrogenase (LDH)
Phosphate

The following components in urine will be determined by means of a Miditron M analyzer:

Protein
Glucose
Blood

Blood collection kits will be prepared tailor made, defined according to the need for every single study visit. 10 % of all kits will be checked for consistency and if mistakes are found all kits will be checked.
Data will be organized in files according to specifications agreed upon. Before transmission of data all files will be reviewed for correctness and format consistency.

Remnant Sample material from Pharmacokinetik (PK) and antibody analyses will be stored below -16 °C. The samples will be traced by means of Unilabs freezer management system, which identify the placement of every single sample, the date of placing the sample and a tracing log if the sample is moved from one freezer to another.