We handle all essential in-process and release testing, from bulk harvest to drug substance (DS) and drug product (DP) release, ensuring that your biologic product consistently meets these critical quality standards. Our platform methods ensure that your biologic’s early-phase development is efficient, regulatory-compliant, and ready for rapid clinical progression.
Our Platform Services include a broad range of standardized assays and characterization techniques, such as:
In-Process Testing
- Monitoring key attributes like titer (in g/L), glycan variants, charge heterogeneity & size heterogeneity to ensure the desired product quality during the process optimization.
- Detection of impurities and by-products during production to prevent batch failure.
Release Testing (Drug Substance and Drug Product)
- Quantification: IgG titer estimation, protein concentration by Fixed path length (UV spectrophotometry)/ by Variable path length (Stunner).
- Purity & Impurity Profiling: Identification of high-molecular weight aggregates, low-molecular weight fragments, and process-related impurities like host cell proteins (HCP) and Host cell DNA (HcDNA) through techniques like Size Exclusion Chromatography (SEC), CE-SDS, RT-PCR and ELISA.
- Identity Testing: Verifying the protein sequence, post-translational modifications, and glycosylation profiles using techniques like peptide mapping, cIEF, and RP-LC.
- Charge Heterogeneity: Analysis of charge variants to ensure product consistency using Ion Exchange Chromatography (IEX).
- Safety Testing: Ensuring product safety by performing sterility, endotoxin, and bioburden testing.
- Stability Studies: Ensuring long-term product integrity by testing for forced degradation and assessing stability under different conditions (freeze-thaw, thermal stress, etc.).
With our robust, reliable, and standardized Platform Methods, you can confidently advance your biologic through early development and Phase 1 clinical trials. Our approach provides high-quality, reproducible data, ensuring regulatory compliance, accelerating decision-making, and mitigating risks—all crucial elements for success in the biologics space. By leveraging Aragen’s Platform Methods, your biologic progresses efficiently through early development, setting the foundation for long-term success in the global marketplace.