Nelson Laboratories is expanding global pharmaceutical capabilities to meet the needs of our clients and partners. To ensure we offer the most comprehensive test services for parenteral and ophthalmic products, we are consolidating and expanding our services in Itasca, Illinois. This complements our pharma services at our Nelson Labs European Center of Excellence (Leuven, Belgium) and our Nelson Labs Global Headquarters (Salt Lake City, Utah).
Services, Equipment & Expertise
Our primary focus with this expansion will be to offer Chemical, Manufacturing and Controls (CMC) test support for pharmaceutical manufacturers with Analytical Research & Development (ARD), Raw Materials Testing (RMT), Stability studies and routine Quality Control batch release tests with both microbiological and analytical capabilities.
Nelson Labs Itasca more than doubles our lab space for pharmaceutical services in North America with 30,000 sq. ft. of lab and office space that includes the addition of the following equipment:
UPLC (Waters), HPLC (Agilent), IC and LC-MSD
FTIR, UV/VIS, Osmometer, Wet Chemistry & Services for Raw Material Tests
Including Agilent OpenLab and Mettler LabX
For state-of-the-art Sterility Assurance
In addition to these services and equipment, our staff offer a high level of expertise within this field. Our VP of Global Pharmaceuticals, Aryo Nikopour, brings over 30 years of experience with both pharmaceutical and biopharmaceutical product development & support. He is supported by our Leuven team of over 100 experienced pharmaceutical industry experts and our global Regulatory Compliance Associates team. To further build upon this team and ensure that we can fully support your pharmaceutical programs, we are expanding our capabilities by hiring additional qualified chemists and pharmaceutical experts.
Isolator Suite
Nelson Labs has invested in state-of-the-art isolator technologies to ensure sterility assurance services for pharmaceuticals are performed in the best possible facilities. Two SKAN Spectra isolators have been acquired – one is installed at our Nelson Labs Salt Lake City facility and the second will soon be installed and operational at Nelson Labs Itasca.
Key benefits:
- Simplified package validation
- Reduced decontamination cycle time
- State-of-the-art technology with the latest in aseptic design and sterility assurance level
- Installed in Nelson Labs Salt Lake City & Nelson Labs Itasca to provide redundant capacity & capabilities
- SKAN is best-in-class for pharma sterility
Isolator Capabilities by Location
| Service Categories | Drug Phase | Lab Sites |
|---|---|---|
| Sterility Assurance – USP/EP Closed Membrane Filtration • Parenteral Drug • Ophthalmic (eye drops, gels, ointments) • Pre-filled syringes & devices • Other pharma products | Initial Product Qualification Product Validation Clinical Studies QC Lot Release (Routine) | North America Itasca, IL SLC, UT Europe Wiesbaden, DE* |
| Sterility Assurance – USP/EP Direct Immersion • Combination drug/device products • Tissues & tissue-based products • Medical devices | Initial Product Qualification Product Validation Clinical Studies QC Lot Release (Routine) | North America Itasca, IL SLC, UT Europe Wiesbaden, DE* |
| *Wiesbaden offers sterility assurance services in traditional cleanroom suites. | ||
View our full list of Global Pharmaceutical Services.
