Improving Biopharmaceutical Safety Through Verification‐Based Quality Control

Batch testing assumes that all units in a batch are uniform without variability and makes the product release decision based on analysis of one representative unit per batch, increasing the risk of poor-quality drugs.

“(ii) this approach assumes that all the units in a batch are uniform without any variability, and the decision for product release is made based on the analysis of one representative unit for every batch [10]. This increases the risk of the distribution of poor‐quality drugs.”

Most biopharmaceuticals are produced via biosynthesis using genetically modified organisms, unlike small molecules, which are produced through chemical synthesis.

“Unlike small molecules, which are produced through chemical synthesis, most biopharmaceuticals are produced via biosynthesis, using genetically modified organisms [10].”

Batch testing determines quality only after manufacture, leaving limited scope for corrective actions and potentially leading to rejected or failed batches.

“This has two main disadvantages: (i) the quality is only known after the manufacture of the drug, leaving very limited scope for corrective actions, potentially leading to rejected or failed batches”

Biopharmaceuticals are more complex than small molecule drugs, with therapeutic proteins being 50-1000 times larger.

“The drawbacks of the quality by testing (QbT) approach are even more pronounced for biopharmaceuticals, as they are more complex and involve therapeutic proteins being 50–1000 times larger than small molecule drugs.”