Analytical Development
and Method Transfer
Our wide range of technologies and high throughput methodologies can support all stages of development, including method development, characterization, impurity profiling, comparability, lot release, stability and clinical assessment of wide range of biotherapeutic molecules (e.g., monoclonal antibodies, fusion proteins, recombinant proteins and peptides) and efficient product and process characterization through robust set of platform-based physico-chemical and bioassay methods.
Our highly streamlined method transfer approaches will aid in successful implementation and validation in Quality Control laboratories. With experience of delivering on variety of programs, we bring high-throughput analytical automation, with in-house analytical method development, bioassay development and end-to-end physicochemical and functional characterization of biologicals.
Stelis offers services to fulfil your needs through technology, agility and technical expertise.
Method Development
- Product concentration estimation for all modalities
- Process and product-related impurity profiling (both for size and charge)
- Quantitative and qualitative batch release methods
- Optimizing performance in support of process development
In-process Analytics
- HPLC/UPLC based methods
- Process related impurity (HCP, HcDNA) analysis
- Clone analysis through gel electrophoresis, western blot, biolayer interferometry, RTPCR
Bioassays
- Cell-based bioassays
- Quantitative binding ELISA potency and titer determination
- Impurity clearance testing – HCP ELISA, HCD by QPCR
- Binding affinity by SPR (Biacore) or BLI
- Enzyme and viral vector assay
Characterization packages
- Comparability and similarity studies
- Primary structure
- Secondary & higher-order structure
- Product characterization package comprising, structural, physicochemical, functional attributes
Stability
- Product optimization studies
- R&D stage studies
- Product in-use studies
- GMP regulatory submission studies
- ICH compliant, covering zone-based specifications
