APELOA ANALYTICAL TESTING CENTER
Apeloa CDMO launched the Apeloa Analytical Testing Center (AATC) in 2022 to provide an efficient source of specialized analytical testing and development services to customers. Apeloa CDMO concentrated specialized analytical instrumentation and expertise to a central location at its Tospo (China) facility campus. Although each Apeloa manufacturing site has its own analytical laboratory, the central location can perform specialized tests using high-value or specialized equipment and develop or validate new methods. The site also hosts its specialized genotoxic impurity identification services that can classify genotoxic impurities on a five-level scale.
AATC laboratory services include impurity profile studies, toxicology assessments, and structure elucidation, as well as providing comprehensive regulatory support services for drug product R&D and registration. Having a specialized analytical testing center staffed with the most experienced analytical development scientists provides a center of excellence for servicing contract customer analytical needs for pharmaceutical excipients, intermediates, and active pharmaceutical ingredients (APIs).
APELOA ANALYTICAL TESTING CENTER
The 37, 674 ft2 (3,500 m2) Apeloa Analytical Testing Center (AATC) is Apeloa CDMO’s specialized analytical development and testing center housing a full range of advanced analytical instruments operated by an experienced team of chemists and scientists. The facility opened in 2022 at the Tospo (China) facility campus. Having the best analytical equipment and scientists concentrated in one central location allows Apeloa CDMO to provide enhanced analytical development, validation, and testing services to contract customers across the Apeloa CDMO network. With rapid sample transfers, our centralized Analytical Testing Center can quickly perform advanced tests not available at local manufacturing sites quickly to support production and release.
ANALYTICAL TESTING CENTER (AATC) INSTRUMENTATION
Apeloa CDMO’s central laboratory consolidates the most advanced and specialized analytical equipment into a single location where they can be utilized by experienced scientists to develop, validate, and run analytical tests for contract customers. This laboratory hosts a wide range of instruments including:
- X-Ray Diffractometer (XRD) – Rigaku Smart Lab SE
- Nuclear Magnetic Resonance (NMR) Advance NEO 600MHz
- Inductively Coupled Plasma Mass Spectrometer (ICP-MS) – Perkin Elmer NexION 1000G
- LC-Q-TOF Agilent 1290+ 6545
- Differential Scanning Calorimeter (DSC) – Mettler DSC3+
- Thermal Gravimetric Analysis (TGA) – Mettler TGA2
- LC-MSMS Shimadzu LC-400D + TQ8060NX
- LC-MSMS Shimadzu 30AD + TQ8060NX
- LC-MSMS Agilent 1290 +6470B
- LC-MSMS Waters XEVO TQ-XS
- GC-MSMS Agilent + 7000D
- GC-MSMS Shimadzu GC-2030 + TQ8050NX
- Micro Fourier Transform Infrared – FTIR
- High-Performance Liquid Chromatography (HPLC)
- Ultra-High-Performance Liquid Chromatography (UHPLC)
- Gas Chromatography (GC)
APELOA ANALYTICAL TESTING CENTER (AATC) SERVICES
The Apeloa Analytical Testing Center (AATC) offers a full range of analytical services from early R&D to commercial product testing and validation. Our AATC laboratory was designed to deliver the services our contract customers need at every stage of the pharmaceutical product lifecycle. These analytical services include:
- Isolation, purification, and structure elucidation of impurities
- Analytical method development and validation for genotoxic impurities
- Elemental impurity method development and validation
- Thermal analysis (TGA & DSC)
- Crystallographic study with XRD and electron microscope technologies
- Specific surface area, pore diameter, and pore volume analysis
- Unknown impurity identification via 2D High Resolution Mass Spectrometry (HRMS)
We also offer in-silico toxicity predictive services including pre-assessment of potential genotoxic impurities and mutagenicity prediction with Derek Nexus® (expert toxicity) and Sarah Nexus® (statistical mutagenicity) models suitable for ICH M7 guidelines.