Quality control and analytical methods for baculovirus-based products

Recombinant baculoviruses (rBac) are used for many different applications, ranging from bio-insecticides to the production of heterologous proteins, high-throughput screening of gene functions, drug delivery, in vitro assembly studies, design of antiviral drugs, bio-weapons, building blocks for electronics, biosensors and chemistry, and recently as a delivery system in gene therapy. Independent of the application, the quality, quantity and purity of rBac-based products are pre-requisites demanded by regulatory authorities for product licensing. To guarantee maximization utility, it is necessary to delineate optimized production schemes either using trial-and-error experimental setups (“brute force” approach) or rational design of experiments by aid of in silico mathematical models (Systems Biology approach). For that, one must define all of the main steps in the overall process, identify the main bioengineering issues affecting each individual step and implement, if required, accurate analytical methods for product characterization. In this review, current challenges for quality control (QC) technologies for up- and down-stream processing of rBac-based products are addressed. In addition, a collection of QC methods for monitoring/control of the production of rBac derived products are presented as well as innovative technologies for faster process optimization and more detailed product characterization.

Figure optionsDownload as PowerPoint slideHighlights
► Quality, quantity and purity of rBac-based products are pre-requisites demanded by regulatory authorities for product licensing.
► Global/integrated production strategy of rBac-based products is expected to materialize in the near future with the correspondent increase in product quality control.
► Current challenges for quality control technologies for USP and DSP of rBac-based products are addressed.
► A collection of QC methods for monitoring/control of the production of rBac derived products are presented.
► Innovative technologies for faster process optimization and more detailed product characterization are described.