CHAPTER 1

Protein biology and biologic medications

Biologics are a vital part of the care pathway for several major chronic conditions, notably cancer and autoimmune diseases, and the expiry of patents and exclusivity periods for biologics has permitted the development of biosimilars. The introduction of biosimilars has provided patients with improved access to important, life changing therapeutics. Though biologics have been in common use for decades, biosimilars are relatively novel molecules. A biologic is a therapeutic that is derived via naturally occurring processes, many of which are recombinant proteins.

Over time, confidence in the use of biosimilars is increasing; however, they remain a relatively novel class of treatment, and are associated with complex production and regulation processes that may not be well-understood by all.

Biologics, and therefore biosimilars, used for the treatment of cancer are replicas of naturally occurring proteins that are made in vitro. Prior to delving into the complexities and idiosyncrasies of biosimilar manufacture and regulation, this chapter provides the fundamentals of protein synthesis, a natural cellular process that is mimicked in vitro to produce some of the most commonly used biologics, and consequently their biosimilars.

Please wait while flipbook is loading. For more related info, FAQs and issues please refer to DearFlip WordPress Flipbook Plugin Help documentation.

Share content

Other learning chapters

Biologic and biosimilar manufacture

CHAPTER 2

Biologic and biosimilar manufacture

Covering development and manufacture of a biologic or biosimilar, inherent variability and quality management
View chapter
Biologic product stability – background theory

CHAPTER 3

Biologic product stability – background theory

Detailing the types of factors affecting stability and degradation of biologics and biosimilars, and the studies used to measure
View chapter
Interpretation of stability data

CHAPTER 4

Interpretation of stability data

Describing factors to consider for interpretation of stability and the associated data
View chapter