Drug Product Analytical
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Our analytical service teams have more than 200 scientists supporting from pre-formulation and formulation development until commercial manufacturing at any scale. Equipped with state-of-the-art instruments and located at the same site with drug product R&D and manufacturing teams, our analytical services will streamline your drug product development with customized, flexible, and integrated analytical solution.
Our quality control team has more than 200 scientists supporting hundreds of projects at all stages every year, ensuring the highest quality standard meeting all regulatory requirements. Our facilities are equipped the latest digital systems available for onsite and remote inspections. In addition, we support high potency drugs with dedicated high potency QC labs with OEL 10 ng/m3.
In 2023, our drug product QC team
- Supported 150+ projects, including numerous PPQ projects
- Released 1,000+ batches at all stages
250+ Analytical Scientists
In 2023:
- 9,000+ analytical methods developed and validated
- 1,500+ projects supported
550+ QC Analysts
In 2023:
- 11,000+ stability samples
- 1,000+ batches released
Our Capabilities
Container-closure integrity testing (CCIT)
- Quantitative: Vacuum decay method, High-voltage leak detection
- Qualitative: Microbial challenge, Tracer liquid
PAT and continuous manufacturing line
- Online-NIR PAT tool to monitor blend uniformity
Foreign and particulate matter
- Observe in situ, verify by flow imaging (MFI), identify via IR/Raman/EDX
Purity by LC-QTOF
- ID and quantitation utilizing QTOF HRMS and quadrupole LC-MS specifically for hard-to-resolve parental impurity analysis.
Sterility testing and species identification
- Sterility/BET/AET testing for injection and Strain identification to species with Applied Biosystems 3500
