Interferon Beta-1a (DB00060): A Comprehensive Monograph on its Biotechnological Production, Pharmacology, Clinical Efficacy, and Safety Profile in the Management of Multiple Sclerosis

I. Executive Summary

Interferon beta-1a is a recombinant human glycoprotein that represents a foundational, first-generation disease-modifying therapy (DMT) for multiple sclerosis (MS). As a biotech drug produced in mammalian cells, its structure, including critical glycosylation, is identical to that of endogenous human interferon beta. This monograph provides a comprehensive analysis of its molecular characteristics, manufacturing processes, pharmacological profile, clinical development, and extensive safety record.

The primary mechanism of action for interferon beta-1a is immunomodulatory. By binding to Type I interferon receptors, it initiates a complex intracellular signaling cascade via the Jak/STAT pathway, leading to the transcriptional regulation of over 100 genes. The cumulative effect is a shift away from pro-inflammatory and toward anti-inflammatory processes, a reduction in the migration of inflammatory cells across the blood-brain barrier, and a dampening of the autoimmune response directed against the central nervous system. While the precise mechanisms remain incompletely elucidated, this activity translates into a clinically meaningful reduction in relapse rates and a slowing of disability accumulation in patients with relapsing forms of MS.