Quality Control Services
Analytical and Quality Control Services
For Life Sciences, Combination and Drug Product Manufacturing and Lyophilization
Aluris provides analytical and quality control services for biopharmaceutical, in vitro diagnostics, and life science organizations.
Get the expertise and capabilities you need. Our comprehensive portfolio can help you at all growth phases- from development through scale-up, and pre-clinical through commercial.
Analytical and Quality Control Services
Foundational and custom services are available:
Our foundational services include in-process and release testing, stability studies, raw material qualification, and storage. We can fully customize testing processes to meet your needs. Â
Release Testing
- Identity (e.g. spectroscopy, chromatography, immunoassay)
- Potency/performance
- Purity/impurities
- Appearance and pH
- Bioburden and microbiological
- Labeling and packaging integrity
Stability Studies
- Real time and accelerated conditions available
- Freeze-thaw studies
- ICH compliant storage conditions
- ICH Q1A and EP-25A standards
- Non-destructive container-closure testing (CCIT)
- Microbiological testing
Raw Material Qualifications
- Identity testing
- Purity and impurities
- Physical and chemical properties
- Biological and/or functional testing
- Bioburden/sterility/endotoxin
- Full CoA or full compendial verification
Custom Analytical and Quality Control Services
We can fully customize analytical testing processes and quality controls to meet your demands. With a fully equipped lab and experienced staff, we ensure your products meet the highest standards of accuracy, reliability, and regulatory compliance.Â
- Method verification and validation
- Comprehensive reports
- Regulatory submission assistance
Learn more about our available services. Talk to an expert.
Compliance and Security
Staying current on both FDA and ICH guidelines in changing regulatory environments is challenging. Our team prioritizes the quality and security of your product.Â
- cGMP
- 21 CFR 820, 21 CFR 210, 21 CFR 211
- ICH Q1
- Validated environments
- 24/7 monitoring with validated building management system
Know what to expect & when. Talk to an expert.
Analytical testing services provided by Aluris
| Appearance USP <790> | Bioburden USP <61> |
| Color and Clarity Ph. Eur 2.2.2 and 2.2.1 | Endotoxin USP <85> |
| pH USP <791> | HPLC (RP- HPLC, IEX- HPLC, SEC-HPLC) |
| Conductivity USP <1644> | CCIT via Carbon Dioxide Headspace Analysis – Lighthouse Instruments |
| Osmolality USP <785> FPD | Concentration by UV/Vis & Fluorescence |
| Refractive Index USP <831> | Concentration of Nucleic Acids |
| Container Content/Extractable Volume USP <697> | FTIR |
| Viscosity USP <912> | ELISA |
| Fats and Fixed Oil Analysis USP <401> | RT- qPCR |
| Density | DNase and RNase Detection |
| Nitrates analysis for Purified Water | Nicolet Summit FTIR – ThermoFisher |
| UHPLC- Agilent 1290 Infinity II | RX-5000i Digital Refractometer – Atago |
| SpectraMax 384 Plus Spectrophotometer- Molecular Devices (cuvette and 96 well plate reader) | D4 Density Meter – Mettler Toledo |
| Gemini XPS Microplate Spectrofluorometer- Molecular Devices (96 well plate) | CTech SoloVPE System |
| Biotek ELx808 Plate Reader – Charles River | TOC/Conductivity Analyzer- Sievers M9 |
| Milliflex Oasis | Light Box, USP and Ph. Eur compliant – Phoenix Imaging |
| NanoDrop OneC – ThermoFisher | Stability Storage 80°C, 20°C, 5°C, 25°C and 40°C (with %RH for accelerated conditions) |
| Seven Compact pH Meter – Mettler Toledo | Stability Study management ICH Q1A R2 incl. Freeze Thaw studies |
FAQs
Q: What types of QC testing services does Aluris offer?
A: We provide a range of services, including raw material testing, in-process testing, final product release testing, and stability studies
Q: Do you offer stability testing programs?
A: We can design and execute stability testing programs in accordance with ICH guidelines.
Q: How do you handle sample storage and retention?
A: Aluris offers controlled storage solutions and retain samples storage according to regulatory requirements or client-specific agreements.
Q: Can you transfer and validate custom assays?
A: Yes, we provide method transfer and validation services tailored to your product’s specific requirements.
Q: Can you support testing for both clinical and commercial products?
A: Yes, we offer testing services for products at all stages, from clinical development through commercial production.
Q: Can you handle testing for high-potency or hazardous materials?
A: No, we have facilities and protocols to handle materials up to and including SafeBridge category 3 (OEL < 1µg/m3).
Q: Do you provide detailed QC testing reports?
A: Yes, our comprehensive reports include all required data, analysis, and documentation to support regulatory filings and audits.
Q: What kind of support do you offer during audits or regulatory inspections?
A: We provide full audit support, including document preparation, participation in inspections, and responding to regulatory inquiries.
Q: How do you determine pricing for QC services?
A: Pricing is tailored to your specific QC requirements. During the project quoting process, we collaborate with you to assess your needs and incorporate the QC costs into the total project estimate. We can provide you with a price list for the transfer and execution of the various analytical methods we perform.