Quality Control of Injectable Biologics

Biologics exhibit higher molecular weight, complexity in structure, and function that can be affected by changes in the manufacturing process. Initial emphasis on biologics development should be directed to the quality requirements. A variety of excipients constitute the final production of injectable biologics, besides the subtle, process-driving manufacturing operation. Strict quality control is required to ensure quality, efficacy and safety of the biological products. Like the small molecule counterpart, quality control tests must be performed for finished injectable biologics, including Sterility test, Pyrogen test, Clarity test, Leaker test, and Content uniformity test.

Being derived from microbial sources, biologics are more prone to contamination with viruses, mycoplasmas or other microorganisms. Therefore, strict quality control is required to ensure contamination-free quality, efficacy, and safety of biological products. Pyrogen removal can be done by ultra-filtration, ion-exchange chromatography, distillation, active charcoal, or reverse osmosis, followed by pyrogen test. The USP recognizes two pyrogen tests, conducted with rabbits and the Limulus Amebocyte Lysate Viral decontamination is performed by a virus retentive filter under aseptic condition. Biosimilar manufacturing is also briefly reviewed