Biologics are complex, large-molecule medicines derived from living cells or produced through biological processes.¹ Unlike traditional small-molecule drugs made via chemical synthesis, biologics are developed using biotechnology and manufactured in living cells cultured in vitro.¹

IN 1982, THE APPROVAL OF RECOMBINANT HUMAN INSULIN MARKED THE BEGINNING OF MODERN BIOLOGIC THERAPIES³. SINCE THEN, BIOLOGICS HAVE EVOLVED INTO A DIVERSE CLASS OF MEDICATIONS, INCLUDING MONOCLONAL ANTIBODIES, VACCINES, BLOOD PRODUCTS, GENE THERAPIES AND MORE.¹

VARIABILITY BETWEEN DIFFERENT BATCHES OF A BIOLOGIC MEDICINE⁷

Inherent small degrees of variability can be found within consecutive batches of the same biological medicine; for example, in glycosylation,
where the attached sugar molecules can vary slightly. However, even with minor variations in glycosylation patterns (that fall within acceptable limits), there will still be consistency in biological activity between batches. This means that the biological activity of the medicine (encompassing its safety and effectiveness) is consistent across all batches.
Ultimately, the variations are within an accepted range and do not affect the protein’s function.

Strict controls are always applied to ensure that minor variability falls within an acceptable range to certify safety and efficacy. This is done by altering the manufacturing process to guarantee the active substance aligns with the desired specifications range. Whether variability is within a batch or between batches, these quality assurance measures are always in place.