PROXY Laboratories is an independent services provider to the life sciences industry. Its services cover the whole range of quality control (QC) testing, from compendial testing of pharmaceutical raw materials and excipients to release testing of finished products.
In addition, the company performs analytical method development, validation of your cleaning procedures and utilities, stability studies and several types of validation studies.
The range of services offered by PROXY Laboratories includes:
- Fill and finish of clinical trial material under good manufacturing practices (GMP)
- Storage and distribution under good distribution practice (GDP)
- Biochemical and microbiological analyses of biopharmaceuticals
- Development and International Conference on Harmonisation (ICH) validation of test methods
- Stability studies cf ICH
- Bioanalysis of plasma and urine samples
- EU import testing and batch release (QP) services
Aseptic fill and finish of clinical trial material
PROXY provides aseptic fill and finish (F&F) of clinical trial material (CTM) on a small scale (handfilling), into different sizes of vials, bottles, syringes and plastic bags. This service includes master batch record documentation, 100% visual inspection and weight checks, as well as sterility, closure integrity and bacterial endotoxin tests.
As a related activity, PROXY offers the GDP-licensed storage and distribution of CTM for multi-centre clinical trial studies.
QC testing services – chemistry
PROXY provides a range of QC testing services in the field of chemistry, including testing of biopharmaceutical raw materials such as active pharmaceutical ingredients (API) 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 customers’ registration dossiers. Analytical test methods can be validated according to ICH guidelines.
QC testing services – microbiology
In the field of microbiology PROXY Laboratories’ QC testing services include analysing for bioburden (TAMC, TYMC) and for the absence of specific microorganisms such as E coli, Salmonella.
The company uses specialised methods such as the microbiological assay of antibiotics (turbidimetric and cylinder plate), the bacterial endotoxins test (turbidimetric, chromogenic, and gel-clot), and the preservative efficacy test.
Sterility tests are performed in PROXY’s cleanroom, and the firm can develop and validate microbiological test methods and identify microorganisms using MicroSEQ technology.
Analytical R&D for the life sciences industry
PROXY uses sophisticated equipment such as ultra-performance liquid chromatography quadrupole time of flight mass spectrometry (UPLC-QToF-MS) and ultra-performance liquid chromatography coupled to triple quadruple mass spectrometer (UPLC-TQ-MS) for the development and validation of analytical methods to be used for analysing biopharmaceuticals and samples of biological origin (plasma, urine and tissue).
One of our specialised areas is oligos (oligonucleotides, oligopeptides and oligosaccharides). PROXY also carries out molecular identification and characterisation as well as impurity profiling.
PROXY provides pivotal, ongoing (follow-up) and in-use stability studies according to ICH guidelines. Climate-controlled walk-in stability rooms conditioned at 2°C-8°C, 25H60 and 30H65, as well as cabinets at -80°C, -20°C, 2°C-8°C, 15°C, 40H75 and 30H75 (zone IVa) are in place and permanently monitored for temperature and humidity.
PROXY offers products, processes, methods and cleaning procedures for validation studies, all carried out according to ICH guidelines.
PROXY Laboratories also provides specific tests, studies and services, including environmental monitoring, closure integrity testing, and residual solvents (HS-GC-FID/MS), as well as qualified person (QP) services such as batch release, QA-consultancy, CTM storage and supply.