title: Integration of Regulatory Guidelines into Protein Drug Product Development.
abstract: The drug product development process for proteins went through its infancy in the early eighties of last century and is in its maturity today. This has been driven largely by the rapid growth of the biotechnology industry, which led to the development and issuance of many regulatory guidelines/directories, especially those through the International Conference of Harmonization (ICH). These guidelines have certainly guided different aspects of a drug product development process. On the other hand, they were issued separately on different topics and in different time periods. An integration of all relevant guidelines into the corresponding areas in drug product development would greatly facilitate the development process. The purpose of this short review is to integrate the relevant (mainly ICH) regulatory guidelines into protein drug product development and to discuss remaining issues, which may lead to further revision of existing guidelines or development of new ones. Drug product development scientists need to collect adequate and relevant development data for a successful product registration. The key is the ability to justify the final drug product in terms of choice of the drug product formulation, container closure system, and manufacturing process.
  
  
  
  The drug product development process for proteins has matured today, largely due to the rapid growth of the biotechnology industry. In this process, many regulatory guidelines/directories were developed and issued, especially through the International Conference of Harmonization (ICH). However, they were issued separately on different topics and in different time periods. An integration of all relevant guidelines into the corresponding areas in drug product development would greatly facilitate the development process. The purpose of this short review is to integrate the relevant (mainly ICH) regulatory guidelines into protein drug product development and to discuss remaining issues, which may lead to further revision of existing guidelines or development of new ones. Drug product development scientists need to collect adequate and relevant development data for a successful product registration. The key is the ability to justify the final drug product in terms of choice of the product formulation, container closure system, and manufacturing process.
authors.affiliation: Wang Biologics, LLC, Chesterfield, MO 36017, USA; 636-795-0285; wweiwang@gmail.com wei.wang9@bayer.com.
authors.forename: Wei
authors.initials: W
authors.lastname: Wang
mesh_terms: D000818:Animals; D001688:Biological Products / Q000737:chemistry / Q000592:standards; D001709:Biotechnology / Q000331:legislation & jurisprudence* / Q000592:standards; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D055808:Drug Discovery / Q000331:legislation & jurisprudence* / Q000592:standards; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000592:standards; D006801:Humans; D007880:Legislation, Drug / Q000592:standards; D004364:Pharmaceutical Preparations / Q000592:standards; D066329:Protein Aggregates; D011506:Proteins / Q000737:chemistry / Q000592:standards; D014481:United States
chemical_list: D001688:Biological Products; D004364:Pharmaceutical Preparations; D066329:Protein Aggregates; D011506:Proteins
keywords: Aggregates; Closure; Container; Formulation; Particulates; Process