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 el

ADVERTISEMENT

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.


BioPharm International
Volume 26, Issue 3, pp. 52-54

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 BioPharma-ceutical 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 http://uspgo.to/host-cell-protein.

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 USP–NF 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 http://uspgo.to/elemental-impurities.

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


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

Mallinckrodt to Acquire Questcor Pharmaceuticals
April 16, 2014
EMA Warns of Falsified Herceptin Vials
April 16, 2014
PhRMA Report Reveals Growth Trajectories and Policy Factors Affecting Biopharmaceutical Growth
April 11, 2014
Center for Biologics Evaluation and Research Relocates
April 11, 2014
American CryoStem and Rutgers University File Joint Patent on Stem Cell Platform
April 11, 2014
Author Guidelines
Source: BioPharm International,
Click here