ABSTRACT

What's the Deal with Biosimilars?Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development. Part of a two-volume set th

chapter 1|22 pages

Structural and functional elements

chapter 2|44 pages

Immunogenicity considerations

chapter 3|16 pages

Product development strategies

chapter 4|40 pages

Stability and formulation considerations

chapter 5|52 pages

Biosimilarity tetrahedron

chapter 6|78 pages

Recombinant expression systems

chapter 7|44 pages

Upstream systems optimization

chapter 8|52 pages

Downstream systems optimization

chapter 9|102 pages

Single-use manufacturing systems (SUMS)

chapter 10|38 pages

Commercial manufacturing overview

chapter 11|18 pages

Outsourcing considerations