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PROXY Laboratories
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PROXY Laboratories B.V. is an independent services provider to the life sciences industry.
Aseptic Fill and Finish (F&F) of Clinical Trial Medication (CTM) in different sizes of vials, bottles, syringes and plastic bags. This includes: Master Batch Record documentation; 100% visual inspection and weight checks; Sterility, Closure Integrity and Bacterial Endotoxin Tests; etc.
A related activity is the GDP-licensed storage and distribution of CTM for multi-centre clinical trial studies.
Chemistry
Testing of (bio)pharmaceutical raw materials (APIs and excipients), utilities (water and gas) and finished dosage forms, for release as well as stability samples. All tests are carried out according to pharmacopoeia (compendia) and/or customer’s registration dossiers. Analytical test methods can be validated according to ICH guidelines.
Microbiology
Analysing for bioburden (TAMC, TYMC) and absence of specific microorganisms (e.g. E. coli, Salmonella). Other methods and techniques performed are: Microbiological Assay of Antibiotics (Turbidimetric and Cylinder Plate / Agar Diffusion), Bacterial Endotoxins Test (Turbidimetric, Chromogenic, and Gel-clot), Preservative Efficacy Test, Environmental Monitoring, Growth Promotion Test, Disinfectant validations. The sterility test can be performed in a clean room as well as in an isolator. Finally, microbiological test methods can be developed and validated.
In this facility, branded under the name MicroSafe Laboratories, assays are carried out to support biotechnological production processes and safety of product releases. The main areas are Mycoplasma (compendial as well as rapid methods) and in-vitro virus testing.
Examples of the latter are Adventitious Virus Assays (AVA), Replication Competent Retrovirus (RCR) assay, 9-CFR Bovine virus screen and Avian Leukosis Virus assay. For both Mycoplasma and Viruses, inactivation studies can be executed. Molecular biology capabilities include sequence-based identification, iso-enzyme analysis, and various PCRs. Finally, Master and Working Cell Banks (MCB / WCB) can be characterised.
Use of mass spectrometry such as UPLC-QToF-MS, UPLC-TQ-MS and Capillary Electrophoresis (CE) techniques for the development of methods to be used for analysing (bio)pharmaceutical products. A special focus is on oligo’s, i.e. oligonucleotides, oligopeptides and oligosaccharides. Also molecular identification and characterisation and impurity profiling are carried out.
Stability Studies: Pivotal, On-going (follow-up), and In-use studies are carried out according to ICH guidelines. Climate-controlled walk-in stability rooms conditioned at 2-8°C, 25H60 and 30H65 as well as cabinets at -80°C, -20°C, 2-8°C, 15°C, 40H75 and 30H75 (Zone IVa) are in place and permanently monitored for temperature and humidity.
Validation Studies: Products, Processes, Methods, and Cleaning Procedures, all according to ICH guidelines.
Specific Tests, Studies and Services: e.g. Residual Solvents by HS-GC-FID/MS.
Qualified Person Services: Batch release, QA-consultancy, CTM storage and supply.
PROXY Laboratories B.V.
Archimedesweg 25
2333 CM Leiden
The Netherlands
Phone: +31 – (0)71 – 524 4080
URL: www.proxylab.nl
Mr Jan de Vries
Director Marketing & Sales
E-mail: j.devries@proxylab.nl