Partners

Participant 12

Unilabs

Partner 12:
Unilabs a.s., Nygårdsvej 32, 2100 København Ø, Denmark

Key skills:
Central laboratory for pre-clinical and clinical trials

Laboratory background and technical information:
Unilabs is central laboratory for clinical as well as pre-clinical studies. It is a GLP certified and ISO17025 accredited full service laboratory providing assistance within: Method development, Method transfer, Method validation, test compound (PK)-sample analyses, Bio-analytical Reports, Antibody analysis against the test drug, Central laboratory services, Central logistics. Within orphan drug development the laboratory has been involved in central laboratory services of two other compounds produced by Zymenex:

1. recombinant human porphobilinogen deaminase (rhPBGD) for the treatment of Acute Intermittent Porphyria (AIP) and
2. recombinant human arylsulfatase A (rhASA) for the treatment of patients with late infantile metachromatic leukodystrophy (MLD).

In both cases the laboratory determined the test compound (PK) as well as antibodies against the test compound including reporting, besides safety testing, logistics etc. Validation of methods for bioanalysis and „Incurred sample re-analysis“ are done in compliance with:

1. U.S. Food and Drug Administration, Guidance for Industry: Bioanalytical Method Validation, May 2001
2. Fast et.al.: The AAPS Journal 2009; 11 (2), 238-241: Workshop Report and Follow-Up-AAPS Workshop on Current Topics in GLP Bioanalysis: Assay Reproducibility for Incurred Samples-Implications of Crystal City Recommandations.
3. Viswanathan et.al.: The AAPS Journal 2007; 9 (1) Article 4: Workshop/Conference Report—Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays.  (http//www.aapsj.org).
4. Rocci et.al.: The AAPS Journal 2007; 9 (3) Article 40: Confirmatory Reanalysis of Incurred Bioanalytical Samples. (http//www.aapsj.org).

Capacity to contribute to the project:
Unilabs has well-equipped analytical laboratory with state-of-the-art equipment and provides all necessary expertise and personnel for the proper analyses of urine and serum samples obtained from alpha-Mannosidosis patients  within the clinical trials performed during ALPHA-MAN. 

Personnel involved:

• Poul Persson (Project Manager, PhD, M), will be responsible for the overall project, involved in study set-up and maintenance, preparation of all documentation related to the clinical part of the project, and contact to other participants in the project
• Chemist: will be responsible for development and validation of the methods for PK analysis and antibodies against rhLAMAN. Furthermore the chemist will supervise the safety testing and write the Bio Analytical reports
• Bioanalyst: will be involved in method development, validation, and running the PK and antibody analyses throughout the project. Furthermore involved in safety testing and maintenance of QC systems etc.
• Quality assurance Manager: involved in auditing of study plans, validation plans, Bio Analytical Reports, and audits relevant to the project
• Data Manager: involved in setting up the database, preparation of data files, data cleaning, and forwarding of laboratory data electronically
• Logistic Manager: involved in sample monitoring including receipt and inspection of samples, registration, query resolution relating to sample identification, freezer management, kit production, and shipping activities.

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