QUALITY ASSURANCE

Quality Assurance is Critical for Biologics

THE QUALITY OF BIOSIMILARS IS BUILT IN BY DESIGN2,3

Biosimilars are made using a process comparable to that used for originator biologics. Throughout the life cycle of a biosimilar, a multi-phase development, manufacturing, and testing process helps ensure quality. The practice of Quality by Design (QbD) is central to this process and is supported by regulatory authorities like the EMA, and others. Quality by Design is a development approach in which quality is not only tested, it is built into the creation phase.2,3

DEVELOPING QUALITY BIOSIMILARS INCLUDES 3 PHASES

Explore the three C’s that help ensure high quality: Create, Confirm and Control.

CLICK ON A C TO READ MORE ABOUT EACH STAGE

 
 
 

CREATE high-quality biosimilars

Establishing the target product profile, identifying critical quality attributes

The first step in creating high-quality biosimilars is to establish a target product profile (TPP). This is a prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account safety and efficacy of the drug product. Based on the TPP, critical quality attributes (CQAs) are identified. CQAs are the physical, chemical, and biological characteristics of the biosimilar that should be within an appropriate limit, range, or distribution.3

Rigorous testing in product design

A prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account safety and efficacy of the drug product.

Glossary:

Functional: of, connected with, or being a function15

Structural: of or relating to the physical makeup of a thing27

References:

1. Health Canada. Guidance Document Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). June, 2015. 2. European Medicines Agency. Quality by Design. Accessed at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000162.jsp&mid=WC0b01ac058076ed7. 3. European Medicines Agency.ICH guideline Q8 (R2) on pharmaceutical development. Accessed at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002872.pdf. 4. Health Canada. Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs. Revised November 14, 2016. Available online: http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/brgtherap/applic-demande/guides/seb-pbu/seb-pbu-2016-eng.pdf Accessed December 2016. 5. ICH Harmonised Tripartite Guideline. Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals; S6(R1). June 12, 2011. 6. European Medicines Agency. ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/biological entities). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/05/WC500127803.pdf. Published November 2012. Accessed February 21, 2017. 7. Webster Medical Dictionary. Medline Plus. Available at: http://c.merriam-webster.com/medlineplus/functional. Accessed July 16, 2017. 8. Webster Medical Dictionary. Medline Plus. Available at: http://c.merriam-webster.com/medlineplus/structural. Accessed July 16, 2017.