Document Detail


Biologics formulation factors affecting metal leachables from stainless steel.
MedLine Citation:
PMID:  21360314     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
An area of increasing concern and scientific scrutiny is the potential contamination of drug products by leachables entering the product during manufacturing and storage. These contaminants may either have a direct safety impact on the patients or act indirectly through the alteration of the physicochemical properties of the product. In the case of biotherapeutics, trace amounts of metal contaminants can arise from various sources, but mainly from contact with stainless steel (ss). The effect of the various factors, buffer species, solution fill volume per unit contact surface area, metal chelators, and pH, on metal leachables from contact with ss over time were investigated individually. Three major metal leachables, iron, chromium, and nickel, were monitored by inductively coupled plasma-mass spectrometry because they are the major components of 316L ss. Iron was primarily used to evaluate the effect of each factor since it is the most abundant. It was observed that each studied factor exhibited its own effect on metal leachables from contact with ss. The effect of buffer species and pH exhibited temperature dependence over the studied temperature range. The metal leachables decreased with the increased fill volume (mL) per unit contact ss surface area (cm(2)) but a plateau was achieved at approximately 3 mL/cm(2). Metal chelators produced the strongest effect in facilitating metal leaching. In order to minimize the metal leachables and optimize biological product stability, each formulation factor must be evaluated for its impact, to balance its risk and benefit in achieving the target drug product shelf life.
Authors:
Shuxia Zhou; Christian Schöneich; Satish K Singh
Related Documents :
16323944 - Characterization and ab initio xrpd structure determination of a novel silicate with vi...
17889844 - Molecular imaging of single cellulose chains aligned on a highly oriented pyrolytic gra...
17432834 - Effects of chain length on the rates of c-c bond dissociation in linear alkanes and pol...
17506044 - Thuggacins, macrolide antibiotics active against mycobacterium tuberculosis: isolation ...
18365074 - Cytotoxicity profiles for a series of triorganophosphinegold(i) dithiocarbamates and tr...
22930554 - Exceptional crystallization diversity and solid-state conversions of cd(ii) coordinatio...
Publication Detail:
Type:  Journal Article     Date:  2011-03-01
Journal Detail:
Title:  AAPS PharmSciTech     Volume:  12     ISSN:  1530-9932     ISO Abbreviation:  AAPS PharmSciTech     Publication Date:  2011 Mar 
Date Detail:
Created Date:  2011-03-30     Completed Date:  2011-11-09     Revised Date:  2013-06-30    
Medline Journal Info:
Nlm Unique ID:  100960111     Medline TA:  AAPS PharmSciTech     Country:  United States    
Other Details:
Languages:  eng     Pagination:  411-21     Citation Subset:  IM    
Copyright Information:
© 2011 American Association of Pharmaceutical Scientists
Affiliation:
BioTherapeutics Pharmaceutical Sciences, Global Biologics, Pfizer Inc, St. Louis, Missouri 63017, USA. shuxia.zhou@pfizer.com
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Descriptor/Qualifier:
Biological Agents / chemistry*
Buffers
Chelating Agents
Chromium / analysis*
Drug Compounding
Drug Contamination*
Humans
Hydrogen-Ion Concentration
Iron / analysis*
Metals / chemistry
Nickel / analysis*
Stainless Steel*
Surface Properties
Chemical
Reg. No./Substance:
0/Biological Agents; 0/Buffers; 0/Chelating Agents; 0/Metals; 12597-68-1/Stainless Steel; 7439-89-6/Iron; 7440-02-0/Nickel; 7440-47-3/Chromium
Comments/Corrections

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


Previous Document:  Development of indinavir submicron lipid emulsions loaded with lipoamino acids-in vivo pharmacokinet...
Next Document:  Solid dispersions of imidazolidinedione by PEG and PVP polymers with potential antischistosomal acti...