Analytical Development
BioCina combines method transfer, development, qualification, and validation into an integrated analytical method lifecycle service offering, rather than treating them as separate elements. We develop analytical methods for microbial, plasmid DNA, mRNA drug substance, and non-sterile drug products as well as sterile drug product programs.
Fit-for-Purpose and Phase-Appropriate
We define an Analytical Target Profile and establish the measurement requirements for Critical Quality Attributes. Methods are developed to be fit-for-purpose and qualified or validated to a phase-appropriate level. Throughout the method lifecycle, and as method and process understanding grows, procedure performance verification ensures that methods remain fit for intended use. This ensures methods are ready for all phases.
End-to-End Offering
Analytical development activities occur in parallel to process development. While our analytical development services are part of our end-to-end development and manufacturing service offering, they are also offered as standalone services.
We conduct stability studies to determine product shelf life and to meet any special requirements clients may have.
Summary of Our Analytical Offering
- Target product profile (TPP) development
- HPLC/UHPLC with UV or FLR detection utilising Waters™ Empower platform
- Development of size-exclusion, ion-exchange, reversed-phase and hydrophobic interaction methods
- Waters BioAccord LC-MS system
- CE-SDS, cIEF utilising SciEx BioPhase 8800 system for rapid method development and analysis
- Peptide mapping for confirmation of protein identity
SDS-PAGE and Western Blotting - UV spectroscopy
- ELISA potency tests
- HCP, endotoxin, bioburden and HC-DNA assays for testing purity and safety
- Development of enzymatic, and colorimetric assays
- Bioassay
- Particle-size, zeta potential and melting point testing
- Forced degradation studies
- Extended product characterisation
- Product comparability
- Multifactorial Design of Experiments
- Extended product characterisation
- Stability studies:
- Client reviewed and approved stability protocols
- QC review summary of results provided at each time point
- Capacity to support all ICH long-term, accelerated and stressed stability requirements
- 24-hour monitoring of stability chambers and freezers with emergency backup
Analytics for Every Offering
Microbial
Development of new analytical methods and tech transfer of established methods, validation and extended product characterisation, and stability testing.
Plasmid DNA
Qualified methods for all the testing you need to release a plasmid product for human use.
LNP
Lipid Nanoparticle (LNP) encapsulation services offering can support a wide range of applications.
Drug Product
Development, formulation, and analytical services for sterile liquids, clinical and commercial fill and finish manufacturing for small molecules and biologics.