Compared to a small molecule pharmaceutical that is likely to have a handful of CQAs, a biopharma product can have as many as 15–30 CQAs. “One is the complexity of this class of products. Anurag Rathore, professor at the Department of Chemical Engineering, Indian Institute of Technology. “There are two major factors,” explains Dr. What makes analytical testing of biopharmaceutics a challenging task?Īnalytical testing is a pivotal step in the development and approval of biopharmaceuticals, but it comes with its own set of challenges.
Such attributes can be assessed by multiple analytical procedures, each yielding different results. The International Council for Harmonization (ICH) Q8 (R2) defines CQAs as “a physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range or distribution to ensure the desired product quality”. Analytical testing is also one of the critical steps toward achieving a successful biosimilar (follow-on biologics) approval.Īnalytical testing provides the information needed to produce a safe and effective biopharmaceutical product, and the efficacy or safety depends on a product’s critical quality attributes (CQA). Thus, extensive characterization and an arsenal of analytical techniques are required to support a biopharmaceutical product from discovery to market entry. Unlike chemically synthesized drugs, most biopharmaceuticals are highly complex molecules produced through a multistep manufacturing process in living systems such as microorganisms, animals or plants. Biopharmaceuticals – or biologics – are a rapidly growing segment of the global pharmaceutical market that has revolutionized the management of hard-to-treat diseases such as cancer and autoimmune disorders.īiopharmaceuticals include therapeutic preparations such as proteins, antibodies and DNA preparations.
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