ANALYTICAL METHOD DEVELOPMENT
Expert Analytical Solutions For Your Product
At Altruist, our analytical development team specializes in method development, transfer and phase-appropriate validation to meet CMC requirements to assess the physiochemical and biochemical characteristics of each product, as well as comprehensive characterization analysis including primary and higher-order structures, and immunological properties.
Method Development & Optimization
With up-to-date knowledge of regulatory requirements, our expert staff can provide and execute customized method development plans to meet your timelines.
Method Qualification & Validation
For DS/DP release assays, we provide analytical method qualification and validation through product-specific, process-related, and microbiological methods – all following ICH guidelines.
Method Transfer
We provide method transfer services to support characterization methods as well as GMP clinical/commercial release and stability testing.
Method Lifecycle Management
Our experts can provide continuous method evaluation throughout your product’s lifecycle.
Analytical Testing & Characterization Capabilities
Our capabilities and cutting-edge analytical instrumentation cover the requirements for comprehensive cGMP quality control testing. Among several identity methods, the multi-attribute method (MAM) is used to determine the amino acid sequence and identify post-translational modifications.
From characterization to stability testing, we offer a range of in-house analytical services tailored to biologics development.
- Method transfer
- Development of customized methods, including bioassays
- Biological, physiochemical, bioactivity, biosafety and characterization testing
- Phase-appropriate validation
- In-process and release testing
- cGMP stability studies
- Clinical in-use studies Comparability testing for both clinical and post-approval process changes
- Similarity study for biosimilar development
- Characterization capabilities for IND/IMPD or BLA/MAA filings
- Standardized sample management workflow Fully automated and high throughput sample preparation platform (Tecan) and testing equipment (LabChip)
- Quality by design (QbD)-guided product critical quality attribute (CQA) assessment
Analytical Method
- Purity: CE-SDS, SEC, icIEF,CEX
- General/Safety/Appearance: Compendial Testing to USP, EP, JP, etc
- Quantity: Protein concentration
- Potency: Binding ELISA, bioassay
- Identity: Peptide mapping, icIEF, IEX and FFE
- Impurity: Residual DNA, HCP, Protein A
Extended Characterization
- Primary Structure: Intact Molecular Weight, Reduced Molecular Weight, Identification of CDR region, Amino acid sequence coverage, Disulfide bond analysis
- Higher-Order Structure: Free sulfhydryl group analysis, CD, FT-IR, NMR, Thermal stability
- PTM: Oxidation sites and proportions, Deamidation sites and proportions, N-glycosylation site, N-glycosylation profiling
- Purity: Aggregates and fragments
- Charge variants: Acidic variants, basic variants
- Glycosylation Heterogeneity: Site, Occupancy, Glycan profiling, -Potency and Immunology properties: Binding Affinity, Cell-based biological activity, ADCC/CDC/ADCP, SPR, Affinity with FcRn, Affinity with the FcγRⅠ, FcγRⅢa, Affinity with C1q
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Ready to Take The Next Step?
From process development to clinical and commercial cGMP release testing, discover how we can support your analytical needs with quality CMC-focused services.