An initiative to manufacture and characterize baculovirus reference material

Abstract

This letter to the editor brings to the attention of researchers an initiative to develop a baculovirus reference material repository. To be successful this initiative needs the support of a broad panel of researchers working with baculovirus vectors for recombinant protein production and gene delivery for either therapy or vaccination. First there is a need to reach a consensus on the nature of the reference material, the production protocols and the baculovirus characterization methods. It will also be important to define repository and distribution procedures so that the reference material is available to any researcher for calibrating experimental data and to compare experiments performed in the various laboratories. As more and more baculovirus-based products are licensed or in the final stages of development, the development of a repository of baculovirus reference material is timely. This letter describes the requirements for the reference material and for the project as a whole to be successful and calls for a partnership that would involve academic, industrial laboratories and governmental organizations to support this international initiative.

Recent Advances in Our Knowledge of Baculovirus Molecular Biology and Its Relevance for the Registration of Baculovirus-Based Products for Insect Pest Population Control

“…For instance, in vivo production of antiviral agents including human interferon-γ against influenza virus H1N1 in T. ni larvae have been demonstrated Gomez-Casado et al, 2011). Nevertheless, insect cell cultures and BEVs platforms continue to expand the applications of baculoviruses as novel tools for vaccine development, drug screening, and gene therapy (Airenne et al, 2010(Airenne et al, , 2011Cox & Hollister, 2009, Kost et al, 2005, van Oers, 2011. The recent initiative of having a standard baculovirus reference material repository (BRM) will further boost their application and perhaps hasten the regulatory process for registering new baculovirus products (Kamen et al, 2011).…”

“…Nevertheless, insect cell cultures and BEVs platforms continue to expand the applications of baculoviruses as novel tools for vaccine development, drug screening, and gene therapy (Airenne et al, 2010(Airenne et al, , 2011Cox & Hollister, 2009, Kost et al, 2005, van Oers, 2011. The recent initiative of having a standard baculovirus reference material repository (BRM) will further boost their application and perhaps hasten the regulatory process for registering new baculovirus products (Kamen et al, 2011). This initiative was mainly proposed in order to have a proper standard that is acceptable to all researchers in academic institutions, regulatory agencies, and industries (Kamen, et al, 2011).…”

“…The recent initiative of having a standard baculovirus reference material repository (BRM) will further boost their application and perhaps hasten the regulatory process for registering new baculovirus products (Kamen et al, 2011). This initiative was mainly proposed in order to have a proper standard that is acceptable to all researchers in academic institutions, regulatory agencies, and industries (Kamen, et al, 2011).…”

“…Baculoviruses are included in these lists due to recent studies on their potential as tools for gene therapy and requirements for extensive preclinical studies. Baculovirus-based vectors remain promising candidates for gene delivery primarily due to the following attributes: (i) natural occurrence, (ii) host specificity (iii), well characterized genomes (Cohen et al, 2009), (iv) genetic stability due to lack of reversions or genome integration, (v) rapid and relatively low cost of production to high titers (~ 10 12 pfu/ml) (Airenne, 2010), (vi) lack of cell substrates associated with animal serum, (vi) large transgene capacity (~100 kb), and allowance for multiple gene inserts, (viii) ability to transduce a myriad of dividing and non-dividing cells (Airenne et al, 2011;Kost & Condreay, 2002) and, (ix) lack of pre-existing immunity.…”

Requirements for baculoviruses for clinical gene therapy applications

“…Certified international reference material for baculoviruses is not yet available but a project has been initiated with the help of The International Society for BioProcess Technology (www.isbiotech.org). (See Letter to the editor by Kamen et al, 2011). Producers should also prepare their own internal reference material (average lot produced) and use this for comparison to control the performance of their assays.…”