Structure and Biochemical Characterization

In the course of clinical development, therapeutic proteins are characterized biochemically, biophysically and biologically to fully understand its structural and functional properties; to assess the criticality of PQA; and ultimately to lay the foundation for product control strategies (specifications, comparability and stability strategies) to follow the ICH guidance of ICH Q8, ICH Q6B, ICH Q9, ICH Q5E, ICH Q2, ICH Q1A (R2) and ICH Q5C (1-7).

Here, Creative Biolabs mainly provides biochemical and biophysical characterization for drug substances and drug products in the later stages of drug development. The characterization details will vary according to different clinical stages of the product.

Primary Structure Characterization >

Biophysical Characterization >

Post-Translational Modification >

Forced Degradation Studies >

Charge Variant Analysis >

Size Variants Analysis >

Key Benefits

✔ Develop and optimize tailored characterization (FDA approved)
✔ Validate custom characterization (FDA approved) according to international guidelines and recommendations (e.g., ICH, US-FDA, ISO, EMEA)
✔ Quality Control: in accordance with GMP / GLP regulations (FDA approved)

Please feel free to contact us for more detailed information.

For Research Use Only | Not For Clinical Use