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Biologics Testing Services
Supporting Regulatory Approval from Development Through Market Entry
The structural complexity and sensitivity of biologics demand a specialized analytical approach. As development timelines tighten and regulatory expectations remain high, many manufacturers look to external partners for biologics testing services that are both technically rigorous and responsive to evolving needs.
BA Sciences offers comprehensive biologics analytical services to support regulatory submissions and ongoing product quality. Our testing programs are designed to meet FDA and EMA expectations and to help accelerate progress toward clinical trials and commercialization.
Analytical Capabilities for Biologics
Our biologics analytical development team works with a wide range of biologic drug formats, including monoclonal antibodies, recombinant proteins, and biosimilars. We provide method development, validation, and cGMP-compliant testing with a focus on accuracy, reproducibility, and regulatory alignment.
Our testing services support:
- Identity confirmation
- Purity assessment
- Structural characterization
- Potency and activity evaluation
- Stability and degradation profiling
We use platform-specific assays tailored to protein-based drugs, including but not limited to:
- Size Variants
- Charge Variants
- Charge Variants
- N-Linked Glycan Profile
- Residual CHO DNA
- Residual CHO Host Cell Protein
- Residual Protein A
- Protein Determination via USP <507>
- UV Spectroscopy via USP <857>
- Total Protein Assay (Residual)
- Determination of Molecular Weight by MALS
- Peptide Mapping
- Intact Mass
- Amino Acid Analysis
Understanding the Distinction Between Biologics and Small Molecules
Testing methods must reflect the differences between biologics and small molecule drugs. Protein-based therapeutics require analytical techniques that account for their size, folding, and post-translational modifications. A pharmaceutical biologics testing partner must be able to navigate these requirements and apply suitable methods to assess structural integrity and product consistency.
For additional information on this distinction, see our blog on the
difference between biologics and small molecule stability testing.
Why Work with BA Sciences
Biologics testing is a dedicated function within our lab. The team brings direct experience with protein-based drugs and applies methods aligned with regulatory expectations from early development through commercial release.
What we provide:
- Specialized personnel focused on biologics assay development, validation, and execution
- A comprehensive service offering, including structural characterization, stability studies, and release testing
- State-of-the-art instrumentation suited for complex biologics analytical development
- Clear project coordination, with defined timelines and responsive communication
Our biologics analytical services are structured to meet technical requirements while helping clients maintain project momentum.