Available online at www.sciencedirect.com

Biologicals 36 (2008) 345www.elsevier.com/locate/biologicals

Editorial

New Cells for New Vaccines II: Focus on Respiratory Virus Diseases

Four articles in this issue of Biologicals (Fedson, Mett, etal., McPherson, and Petricciani and Sheets) are based onpresentations at the IABS International Scientific Workshop,New Cells for New Vaccines II: Focus on Respiratory VirusDiseases, held on September 17e19, 2007, at the Hotel duPont, Wilmington, Delaware, USA. This International Scien-tific Workshop was organized under the auspices of theInternational Association for Biologicals (IABS), InB:Bio-technologies Inc., and the Fraunhofer USA Center forMolecular Biotechnology. The National Institute for Allergyand Infectious Diseases (NIAID), the International Society forInfluenza and other Respiratory Virus Diseases (ISIRV), andRetroscreen Virology Ltd. were co-sponsors. The 2007Workshop follows, and builds on the success of, a two-dayIABS Workshop on new cell substrates that was held inSeptember 2006, in Coral Gables, Florida, USA.

Over 100 participants from 12 countries attended New Cellsfor New Vaccines II; the participants included scientists fromindustry, academia, public health, and regulatory agencies. Theprogram focussed on recent developments in the use of newcell substrates e including mammalian, plant, and insect cellsas well as duck and chick-embryo cell lines e for the manu-facture of vaccines and therapeutic proteins, targeting primarilyinfluenza and respiratory syncytial virus (RSV) disease. Thethree-day program included over 30 scientific presentations,panel discussions, poster sessions, and trade exhibits.

While New Cells for New Vaccines II focused on thedevelopment of RSV and influenza vaccines and the use of newcell substrates in their development, it also addressed a numberof the manufacturing and regulatory issues that attend the useof these cell substrates. An overview of manufacturers’ andregulatory agencies’ evolving perspective on cell substratesover the past 60 years opened the conference. During theconference, industry shared its view on both the advantagesthat accompany particular new cell substrates and themanufacturing and regulatory issues that arise with their use.These new cell substrates do engender a number of heretoforeunfaced regulatory issues. To this end, the US and Europeanregulatory perspectives, as well as the WHO perspective, onthe issues associated with new cell lines were presented.Significantly, as was noted, several products manufactured withnew cell substrates e an influenza vaccine manufactured inMDCK cells and an HPV vaccine manufactured in insect cellse have recently been approved in Europe. Oncogenicity fromDNA deriving from tumorigenic cell lines has been noted as

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a particular concern; in this regard, the need for both removingand degrading DNA has been emphasized. The quantitation ofresidual DNA in vaccines by various methods was reviewedduring the conference, noting especially the dependence ofanalytical sensitivity on the size of the DNA being assayed;a sensitive qPCR-based method utilizing a fluorescence readoutfor DNA quantitation was presented.

Participants in the New Cells for New Vaccines II work-shop heard of the significant progress that is being made inmeeting the increased need and demand for pandemic andinter-pandemic influenza vaccines and the progress on devel-oping immunologic correlates of protection against RSVdisease and in the development of RSV vaccines. Of interestwas the update on the variety of new approaches to influenzavaccines, including both the development of virus derivedantigens and the development of rDNA-derived proteinvaccines. Additionally, with regard to RSV vaccine develop-ment, an exciting update on the use of the cotton rat model asa predictor of vaccine efficacy was presented.

In addition to vaccine production and development, themeeting also provided several updates on the production ofvarious recombinant proteins and monoclonal antibodies inplant and insect cells.

The Chairs of the Workshop were: Drs. Thomas Monath,Yuri Gleba, Reinhard Glueck, Peter Collins, Jean-LouisVirelizier, David Fedson and William Egan.

The International Program Committee for the Workshop was:Drs. Kathryn Zoon, Vidadi Yusibov, Jean-Louis Virelizier, Geof-frey Schild, John Petricciani, Reinhard Glueck, and William Egan.

The 2008 IABS International Workshop, New Cells forNew Vaccines III: From Lab Bench to Clinical Trials will beheld on September 28eOctober 1 at the Hotel du Pont,Wilmington, Delaware, USA. Registration details and theprogram can be found at www.NewCellsforNewVaccines.com.

William EganPharmaNet Consulting

Geoffrey Schild*InB:Biotechnologies, Inc., 9 Innovation Way,

Suite 100, Newark, DE 19711, USA*Corresponding author.

E-mail address: gschild@inb-biotechnologies.com

14 July 2008

shed by Elsevier Ltd. All rights reserved.