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Productivity and operational reliability of recombinant protein and antibody manufacturing have matured to an extent that Drug Substance manufacturing could almost be considered commoditizes. However, there new frontiers in biomanufacturing that will need substantial technology development. In this presentation, we will discuss emerging needs in biomanufacturing, e.g. further industrialization of antibody manufacturing (buzzword Industry 4.0), accelerated manufacturing for early clinical testing, and manufacturing for new therapeutic modalitie
Protein Sciences invented Flublok® influenza vaccine, the first approved recombinant flu vaccine, and its expresSF+® insect cell line and secured FDA approval in 2013. However, none of this was easy or straightforward. This talk will focus on the difficulties encountered in overcoming the FDA’s concerns about a novel cell line, adventures in scale up in multiple countries, the problems developing companies encounter in marketing a novel flu vaccine and the prospects for such companies to succeed in this field.
The production of safe and efficacious vaccines at low cost is essential to guarantee world-wide vaccine availability and affordability, especially in developing countries. Our proprietary PER.C6® cell line and PIN platform technologies have enabled the expression and production of viral vaccines at very high titers in cell cultures, thereby shifting the opportunities for further cost reduction to the downstream process (DSP). To reduce experimental workload needed for DSP development, a systematic approach involving the combined use of statistical DoE and in silico process modeling is proposed. This is exemplified by way of a case study involving the optimization of a chromatographic step for purification of a viral vaccine from PER.C6® derived cell culture harvest. The optimization problem involved four experimental factors (column load, flow rate, upper cut point, virus strain) and two outputs (virus purity and yield). The main objectives of the study were to define a design space satisfying all design constraints, and to define a higher operating column load (within the design space) so as to reduce column and buffer footprints (cost). Through the combined use of statistical DoE and in silico modeling, it was possible to achieve the set objectives with much fewer experiments than would have been needed with a purely DoE approach.
Genetic mutations that occur during cell passaging in a bioreactor can lead to a heterogeneous population. These new mutations may impact product production and quality where small sub- populations could potentially overtake the initial cell culture, resulting in a final cell population that is different from the starting pool. For vaccine manufacturers, occurrence of mutations during cell culturing poses a risk to the use of recombinant proteins. The evaluation of gene copy numbers by a qPCR method is one of the common approaches used to assess the consistency of cell lines. However, due to several challenges including amplification efficiency differences that were apparent between these reference standards and test samples, two new approaches (Digital PCR and High throughput sequencing) were developed in our platform. The developed methods were able to overcome the challenges associated with the conventional methods such as qPCR. These technologies have been successfully used to characterize the genetic stability of cell lines including transgenic cell lines.