ABSTRACT
While sterile dosage forms have always been an important class of pharmaceutical products, the last decade has seen many changes and advancements in the global regulatory landscape concerning the development of new sterile products and therapies. Many among a newer class of products, particularly, biological and biotechnological products, and peptides can only be administered by injection. Rapid innovation and growth in the area has meant a significant increase in the number of products that can only be administered parenterally, and this growth is expected to continue over the next decade.
