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Viral vector N-1 intensification reduces seed train vessel number, media volume and time
The demand for gene therapy viral vectors requires manufacturing processes to scale up to 2000 L. Viral vector production at this scale requires a 9- to 12-day seed train with two to three seeding bioreactors, increasing the risk of failure and manufacturing cost. Perfusion-based cell culture intensification techniques shorten and simplify the seed train for recombinant proteins and monoclonal antibodies production by reducing time, equipment, bioreactor size and cost while increasing the potential number of batches per year. This webinar will discuss similar efficiency gains for three different viral vectors (lentivirus, AAV8 and AAV9) through intensification using KrosFlo® TFDF® Technology that resulted in reduce train vessel number, N-1 vessel size, media volume and time.
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Innovative, differentiated technologies advancing new modalities: Case studies in mRNA & viral vectors
The unprecedented therapeutic potential of new modalities are accompanied by multiple new manufacturing challenges. Implementing smaller, more flexible manufacturing facilities, modalities with greater shear sensitivity, and speed to clinic, demand innovation of technologies that were largely developed for monoclonal antibodies. Innovations in upstream intensification and downstream operations that specifically benefit new modalities, like mRNA and viral vectors, are described.
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Strategic considerations to future-proof single-use assemblies
The advantages of single-use flow paths can be impaired by design, component sourcing, quality and lead-time challenges. Repligen has built new start-of-the-art facilities and assembled a unique set of both plastic and valve technologies that enable rapid design and manufacture of complex flow paths with flow control at high capacity. This webinar will discuss how vertical supply chain security, facility design, expert consultation and advanced componetry deliver differentiated single-use solutions
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Takeda: Validating the Gold Nanoparticle Test with the CTech™ SoloVPE® System Publication
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Evaluating DNA purity ratio determination with the CTech™ SoloVPE® System White Paper
Spectrophotometric analysis is one of the most common techniques used to quantitate nucleic acids in a solution. However, traditional fixed-pathlength spectrophotometers have limitations when determining the purity ratios of these molecules. In this study, the CTechTM SoloVPE system assessed theoretical DNA purity ratios by utilizing its variable pathlength method, known as Slope Spectroscopy. The method was evaluated by assessing the specificity, intermediate precision, repeatability, linearity, and accuracy of the theoretical purity ratios. The observed purity ratios from the SoloVPE system demonstrated great comparison to the theoretical purity ratios, verifying the SoloVPE system’s slope spectroscopy method to be preferable for this application. Authors: Nigel Herbert, Drusha Purohit, Hannah Mignault
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Validating Protein Concentration of Antibody-Drug Conjugates with the CTech™ SoloVPE® System
 UV-Vis spectroscopy is the simplest and most common method to determine protein concentration of ADCs; however, traditional fixed-pathlength spectrophotometers have issues. Authors: Nigel Herbert, Joshua Das, Priya Patel-Abbvie
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SpectraPor® Biotech Grade Cellulose Ester (CE) Dialysis Membrane
Repligen produces molecular porous Biotech Grade Cellulose Ester (CE) membranes in a large range of MWCO’s specifically for critical MW separations using a proprietary casting process free of heavy metal and sulfur contaminants.  The CE dialysis tubing is ultra-pure and does not require special cleaning or treatment.
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DOC0237 PATsmart FlowVPE & FlowVPX Systems with the KrosFlo KR2i System using the Konduit Analog Control
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rSPA Ligand
Native Recombinant Staphylococcal Protein A Ligand (rSPA) is the most advanced non-mutant Protein A ligand available from Repligen. 
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Viral Filtration Integrity: Validating the Gold Nanoparticle Test with the CTech™ SoloVPE® System White Paper
In this study, gold nanoparticles in downstream bioprocessing are determined utilizing the CTech™ SoloVPE® System with variable pathlength technology to perform the Slope Spectroscopy® method. This paper demonstrates the suitability and utility of applying the SoloVPE System in place of traditional spectrophotometers for supporting in-process viral filtration integrity tests. With the passing of all predefined acceptance criteria, it is concluded that the SoloVPE instrument is capable of measuring the gold particle solution within specified accuracy, repeatability, specificity, and linearity. Authors: Takeda-Ablatt Mahsut, Piyush Jain, Matt Diamond-Jones, Donald Gillies, and Nigel Herbert
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