Sterilizing Filtration of Adjuvanted Vaccines: Ensuring Successful Filter Qualification - Filterability and bacterial retention must be verified very early in process development to ensure successful

ADVERTISEMENT

Sterilizing Filtration of Adjuvanted Vaccines: Ensuring Successful Filter Qualification
Filterability and bacterial retention must be verified very early in process development to ensure successful sterilizing filtration validation.


BioPharm International Supplements


Acknowledgement

We would like to thank our colleagues from the Pall Scientific Laboratory Services group and Vincent Guercio in particular, for their efforts in collecting and analyzing field data for this article.

ANNELIES ONRAEDT, PhD, is a global vaccine market manager, MARTHA FOLMSBEE, PhD, is a staff scientist, ANIL KUMAR is a principal R&D engineer, and JEROLD MARTIN is a senior vice president of global scientific affairs, all at Pall Life Sciences, Fribourg, Switzerland, +41 26 350 5360,

References

1. The European Medicines Agency. Guideline on adjuvants in vaccines for human use. Brussels, Belgium. 2004 Mar. Available from: http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/11/WC500015469.pdf.

2. Van Nest G. Trends in developing new vaccine adjuvants. Vaccine Europe; 2009 Nov 17–18; Brussels, Belgium.

3. Guy B. The perfect mix: recent progress in adjuvant research. Nature Rev Microbiolog. 2007;5:505–17.

4. Goldbach P, Brochart H, Wehrle P, Stamm A. Sterile filtration of liposomes: retention of encapsulated carboxylfluorescin. Int J Pharma. 1995;117:225–30.

5. Orsello CD. Novel vaccine adjuvants: What's the future? What are the challenges? A3P conference; 2010 Apr 28; Brussels, Belgium.

6. Fox CB. Squalene emulsion for parenteral vaccine and drug delivery. Molecules. 2009;14:3286–312.

7. Richard A, Delvaux J, Bonnet LB. Effect of sterilizing-grade filters on the physico-chemical properties of onion-like vesicles. Int J Pharma. 2006;312:144–50.

8. Tsukada Y, Hara K, Bando Y, Huang CC, Kousaka Y, Kawashima Y, Morishita R, Tsujimoto H. Particle size control of poly (DL-lectide-co-glycolide) nanospheres for sterile applications. Int J Pharma. 2009;370:196–201.

9. Carbrello C, Rogers M. Optimizing vaccine adjuvant filtration. BioPharm Int suppl. Vaccine development and manufacturing: pandemics and beyond. Jan 2010; pp. 21–6.

10. FDA CDER Perspective on Isolator Technology. ISPE Barrier Technology Conference; Rockville, MD; 1995 Dec.

11. Cooney P. FDA CDER, OPS Microbiology. PDA/FDA Forum. Bethesda, MD; 1995 Jul.

12. US Food and Drug Administration. Guidance for industry. Sterile drug products produced by aseptic processing: good manufacturing practice. Rockville, MD; 2004 Sep.

13. European Commission. EU guidelines to good manufacturing practice medicinal products for human and veterinary use: Annex 1 manufacture of sterile medicinal products. Brussels, Belgium; Feb 2008. Available from: http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm.


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

Pandemic Vaccine Facility Dedicated in Texas
September 19, 2014
GSK Fined in China Bribery Scandal
September 19, 2014
Guideline Delineates How to Implement GS1 Standards to Support DSCSA
September 19, 2014
GPhA Supports Restricted Access Bill
September 18, 2014
Baxter Initiates Voluntary Recall of Potassium Chloride Injection
September 17, 2014
Author Guidelines
Source: BioPharm International Supplements,
Click here