Standards-Setting Activities on Impurities - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Standards-Setting Activities on Impurities
USP's focus in 2013 involves standards relating to organic impurities, measurement of residual DNA and host-cell proteins in biotechnology products, and elemental impurities.

Pharmaceutical Technology
Volume 37, Issue 1

Residual DNA and host-cell proteins

Although traditional small-molecule drugs are made through chemical synthetic routes, many biologic and biotechnology products are made using recombinant technologies in host cells designed to produce a genetically engineered therapeutic protein. These recombinant products are often transcribed from human DNA sequences that are placed into host cells such as mouse cell lines, yeast cells, or Escherichia coli. After the cells produce the proteins, they are purified and characterized. Manufacturers of these protein products must be able to demonstrate that their final products contain very low levels of host-cell DNA and proteins because there could be a risk of tumorigenicity or immunogenicity, respectively, from these materials when given to the patient. Currently, USP is developing a chapter on residual DNA, and at least two material reference standards will be available to support the chapter. USP also is developing a general information chapter containing best practices for critical reagent development and characterization as well as development, validation, and use of host-cell protein measurement procedures.

In June 2013, USP will cohost a workshop with the BioPharmaceutical Emerging Best Practices Association (BEBPA) focused on the measurement of residual DNA and host-cell proteins in biotechnology products. The meeting will feature current industry practices and provide perspectives from the regulatory community. For a workshop description and registration information, see

Elemental impurities

Regarding elemental impurities, USP has developed two relevant general chapters—<232> Elemental Impurities—Limits and <233> Elemental Impurities—Procedures. General Chapter <232> specifies limits for selected elemental impurities, including limits for mercury, cadmium, arsenic, and lead—toxic elements commonly found in the environment. In General Chapter <233>, procedures for identifying impurities using inductively couple plasma technology are described. In addition, General Chapter <233> provides validation criteria should a manufacturer choose to use procedures other than the one described in the new general chapters. As is the case with residual solvents, the elemental impurities chapters will be applied to articles recognized in USPNF by means of a General Notices provision, expected to be proposed in January 2013 in Pharmaceutical Forum and become official May 1, 2014. For updated information about the current status of USP's standards on elemental impurities, see

Maura Kibbey, PhD, is senior scientific liaison, Antonio Hernandez-Cardoso, MSc, is senior scientific liaison, and Kahkashan Zaidi, PhD, is senior scientific liaison, all with the US Pharmacopeial Convention (USP).


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: Pharmaceutical Technology,
Click here