This third edition retains the basic scientific principles associated with the previous editions but brings to light the latest challenges associated with preparing, characterizing, formulating and delivering the ever-increasing types of biopharmaceutical molecules into therapeutics. New chapters include biopharmaceutical structure and drug delivery, protein design and engineering, quality by design for biopharmaceuticals, manufacturing and purification of biopharmaceuticals, immune response triggers by route of administration, proteins in the solid state, the challenge of biosimilars, and transdermal delivery of protein therapeutics.

Author Biography

Eugene McNally, PhD, is executive director and head of PPD's Regulatory Consulting Group and is an expert in global chemistry, manufacturing and controls (CMC) Dr. Jayne E. Hastedt is the CEO and co-founder of JDP Pharma Consulting, LLC, which provides CMC consulting services to the pharmaceutical, biotech, and drug device industries