Meet the expert

Dr. John Petricciani

John Petricciani is president of the International Alliance for Biological Standardization (IABS), a non-profit organization devoted to scientific and medical advancement of biologicals. He also serves on the World Health Organization (WHO) Expert Panel on Biologicals, is an adjunct staff member at the John Wayne Cancer Institute, and is an honorary professor of the Institute of Medical Biology at the Chinese Academy of Medical Sciences, China.

Dr. Petricciani currently is licensed to practice medicine in California and Washington, D.C., and has held senior research, medical, and administrative positions in the public and private sectors, including the Pharmaceutical Manufacturers Association and the WHO, where he held a number of positions including chief medical officer.

Dr. Petricciani previously served as the director of the Office of Biologics at the U.S. Food and Drug Administration (FDA).

Dr. Petricciani received a bachelor of science in chemistry from Rensselaer Polytechnic Institute, a master of science in chemistry from the University of Nevada, and a doctorate in medicine (M.D.) from Stanford University. He is a fellow of the Royal Society of Medicine (UK) and has authored or co-authored more than 160 articles on tumor cell assays, cytogenetics, and regulatory policy. Additionally, he is an editorial board member of the journal Biologicals.

Expert Opinion

with John Petricciani, M.D.

Scientific discoveries of the past decades have increased our understanding of underlying disease pathways and identified potential biological products for diagnosis, treatment, and prevention of certain important diseases.1

As new biological medicines become available around the world, healthcare professionals face an increasing number of choices when selecting an appropriate treatment. Concurrently, issues related to manufacturing, including contamination, counterfeiting, and drug shortages, have occurred and can compromise the health and well-being of patients prescribed these medicines.2-4

For biological medicines, variations in the production process can result in unpredictable changes that profoundly alter their safety and efficacy profile.3,5,6 The knowledge, expertise, resources, and track record of a manufacturer and its ability to ensure product quality and supply should be considered when choosing a biological medicine.

Questions and answers with Dr. Petricciani

Where are biologic medicines produced?

Biologicals have been successfully manufactured by various companies around the world for more than 25 years. More recently, newer companies have emerged to develop, produce, and market biotech medicines.
Are there differences in the quality controls and manufacturing standards between the biologic-drug product process in the U.S. and the processes in other parts of the world?

Each country or region such as Europe has their own requirements and standards. In addition, the World Health Organization publishes international guidelines that are frequently adopted by developing countries. While there may be some differences between requirements in the U.S. and other parts of the world, the basic elements are the same.
What is the background, education, and training of the individuals who oversee the quality and safety of the biologic drug manufacturing process in the United States?

The FDA has established general criteria that must be met by individuals who are responsible for the duties that are assigned to them in manufacturing (21 CFR 211.25). FDA requires a quality system approach in which managers define the appropriate qualifications for each position.
What were the major breakthroughs that made mass production of biotechnology-based drugs possible?

There were several scientific advances that paved the way for the biotech industry to become an important player in the development of new medicines. The first breakthrough was recombinant DNA technology that made it possible to insert specific genes into cells so the cells could then produce a specific protein. A similar breakthrough occurred with the development of hybridomas and monoclonal antibodies. And finally, improvements in large-scale cell culture technology allowed mass production to become a reality.

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References
  1. Meibohm B. The role of pharmacokinetics and pharmacodynamics in the development of biotech drugs. In: Meibohm B, ed. Pharmacokinetics and Pharmacodynamics of Biotech Drugs: Principles and Case Studies in Drug Development. Weinheim, Germany: Wiley-VCH Verlag GmbH & Co.; 2006:3-13.
  2. Liang BA. Regulating follow-on biologics. Harvard J Legislation. 2007;44:363-471.
  3. Schellekens H. Biosimilar therapeutics—what do we need to consider? NDT Plus. 2009;2(suppl 1):i27-i36.
  4. Sekhon BS, Saluja V. Biosimilars: an overview. Biosimilars. 2011;1(1):1-11.
  5. Lee JF, Litten JB, Grampp G. Comparability and biosimilarity: considerations for the healthcare provider. Curr Med Res Opin. 2012;28(6):1053-1058.
  6. Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars. Ann Oncol. 2008;19(3):411-419.