Comprehensive in-house analytical and microbiological testing:
- Method development and validation for release and stability testing
- Stability-indicating assays and related substances
- Cleaning verification and validation
- Microbiological method development and validation
- Microbiological testing (endotoxins, TAMC, TYMC)
- Sterility testing
- Mutagenic impurity assay development
Advanced techniques and equipment to deliver precise, reliable results for your program:
- HPLC/UHPLC with UV, DAD, CAD, Conductivity, Fluorescence, and radiochemical detection
- NMR and MS-MS for structure confirmation
- Karl Fischer (KF) moisture determination
- Gas Chromatography (GC) analysis
- ICP-MS for elemental impurity analysis (ICH Q3)
- Residue on Ignition (ROI)
- Infrared (IR) spectroscopy
Arcinova: Your partner in analytical method development and QC testing
Analytical development tailored to your molecule
Rigorous microbiological controls to safeguard your product
Preventing contamination is critical at every stage of drug development – from API release to final product. Our on-site capabilities include microbial enumeration (TAMC and TYMC), detection of specific microorganisms, and bacterial endotoxin and sterility testing.
Our expert microbiology team specialises in developing and validating pharmaceutical-grade methods to ensure product safety, avoid delays, and maintain compliance across your programme.
Integrated analytical, process R&D and manufacturing to manage impurities
Identifying and characterising impurities early ensures your API stays within specification. Our chemists work closely with analytical and QC teams to generate robust data quickly, enabling effective control strategies across process R&D.
Seamless in-house tech transfer and 24/5 support from our production analytical team keeps your programme on track and off the critical path.
Advanced chromatographic techniques to control impurities
Accurate impurity profiling is critical to product safety and regulatory compliance. Chromatography plays a key role in our approach, and we use techniques such as HPLC and HS-GC to assess potency, related substances, degradants and residual solvents.
We also offer chiral methods to separate enantiomers, and apply validated approaches to quantify GT- and PM-impurities with high sensitivity and ICH-aligned limits.
Integrated approaches to molecule development within drug substance
A core strength at Arcinova is our fully integrated approach to drug substance process research, development and manufacturing – all delivered from our state-of-the-art facility in Alnwick, UK. Seamless coordination across PR&D, analytical and GMP teams helps accelerate timelines and ensure consistent product quality.
We embed stringent quality control measures throughout manufacturing, supported by robust, ICH Q11-aligned analytical capabilities. This integration enables the delivery of high-quality API and lays a strong foundation for QbD filings as your program progresses.
