BIOT5500 (Concepts in Regulatory Science) course reviews and ratings at Northeastern (NEU). Compare professors with RateMyProfessor reviews.
Introduces the science that supports regulatory affairs in the biopharmaceutical industry. Focuses on the methods and instruments used to characterize the processes and products of biotechnology including the production, separation, purification, characterization, and formulation of biologics; the pharmacokinetics of proteins; chemical and biological equivalencies of biogenerics; stability testing; high throughput assays; cell system expression; variants; method validation; and quality control.
Data updated October 2026.