Biological Product Types

Biopharmaceuticals is a growing field and covers recombinant proteins through particles and viruses to human cell-based products. Since the early recombinant proteins in the 1980s and early 1990s grown in hybidomas, recombinant protein manufacture has become a highly defined process using state-of-the-art processes and raw materials from highly characterized starting materials. During the 1990s, processes moved away from serum products and other undefined raw materials to reduce the burden of adventitious and endogenous viruses and TSE. The first cell-based products came to the clinic in the 1990s and the distinction of somatic cell therapy vs. tissue products came into the regulatory lexicon. Gene therapies from biopharmaceutical processes, including LV and AAV, are coming through to commercialization. REGEXBIO can assist in development of all biological product types with experience at BLA/MAA for a wide range of products including many recombinant proteins, mAbs and gene therapy products.

The regulatory landscape and guidance-based expectations have grown enormously during this time, and biopharmaceutical remain distinct from chemical entities.