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<br /> BioProcess<br /> International<br /> DIGITAL EDITION<br /> ARCHIVE<br /> June 2021 | Volume 19 | Number 6<br /> www.bioprocessintl.com<br /> BioProcess<br /> International<br /> Covering the whole development process<br /> for the global biotechnology industry<br /> CELL<br /> AND GENE<br /> THERAPIES<br /> · Mesenchymal Stem Cells Reinvigorated<br /> · Raw Materials for Advanced Therapies<br /> · Facility Design Considerations<br /> · Analytical Method Development<br /> • FEATURED REPORT: Cell Banking<br /> · Building Flexibility and Scalability<br /> into Advanced Therapy Production<br /> · Exosome Purification By Affinity<br /> · Measuring Gene Therapy Viral Titers<br /> · Artificial Intelligence in Healthcare<br /> PendoTECH® TFF Process Control Systems<br /> an extremely valuable tool in biopharm and viral vector process development & pilot scale production<br /> PendoTECH® 5 Station TFF Screening System<br /> 6WDWLRQVRID7DQJHQWLDO)OR<a title="June 2021 page 1" href="https://secure.viewer.zmags.com/publication/a11785aa?page=1"> BioProcess International DIGITAL EDITION ARCHIVE</a> <a title="June 2021 page 2" href="https://secure.viewer.zmags.com/publication/a11785aa?page=2"> June 2021 | Volume 19 | Number 6 www.bioprocessin</a> <a title="June 2021 page 3" href="https://secure.viewer.zmags.com/publication/a11785aa?page=3"> PendoTECH® TFF Process Control Systems an extreme</a> <a title="June 2021 page 4" href="https://secure.viewer.zmags.com/publication/a11785aa?page=4"> Experience. Facility. Location. </a> <a title="June 2021 page 5" href="https://secure.viewer.zmags.com/publication/a11785aa?page=5"> BioProcess International Highlights . . . . . . .</a> <a title="June 2021 page 6" href="https://secure.viewer.zmags.com/publication/a11785aa?page=6"> YOUR GLOBAL DUAL SOURCE FOR BIOLOGICS GMP </a> <a title="June 2021 page 7" href="https://secure.viewer.zmags.com/publication/a11785aa?page=7"> JUNE 2021 www.bioprocessintl.com/eBooks Our 2021</a> <a title="June 2021 page 8" href="https://secure.viewer.zmags.com/publication/a11785aa?page=8"> Process </a> <a title="June 2021 page 9" href="https://secure.viewer.zmags.com/publication/a11785aa?page=9"> FROM THE EDITOR W e've reached </a> <a title="June 2021 page 10" href="https://secure.viewer.zmags.com/publication/a11785aa?page=10"> DEVELOPING GENE THERAPIES IS SCI</a> <a title="June 2021 page 11" href="https://secure.viewer.zmags.com/publication/a11785aa?page=11"> BioProcess Insider The BioProcess Insider digital</a> <a title="June 2021 page 12" href="https://secure.viewer.zmags.com/publication/a11785aa?page=12"> BPINSIDER CoGS. “If you remove people [from a pro</a> <a title="June 2021 page 13" href="https://secure.viewer.zmags.com/publication/a11785aa?page=13"> FOCUS ON... COMPLIANCE Mesenchymal Strom</a> <a title="June 2021 page 14" href="https://secure.viewer.zmags.com/publication/a11785aa?page=14"> without toxicity to the cells. MSCs in cancer can</a> <a title="June 2021 page 15" href="https://secure.viewer.zmags.com/publication/a11785aa?page=15"> investment in the MSC field while research was st</a> <a title="June 2021 page 16" href="https://secure.viewer.zmags.com/publication/a11785aa?page=16"> Accelerate allogeneic cell therapy success Incr</a> <a title="June 2021 page 17" href="https://secure.viewer.zmags.com/publication/a11785aa?page=17"> FOCUS ON... OPERATIONS Raw Materials for</a> <a title="June 2021 page 18" href="https://secure.viewer.zmags.com/publication/a11785aa?page=18"> nothing being approved by the US Food and Drug Ad</a> <a title="June 2021 page 19" href="https://secure.viewer.zmags.com/publication/a11785aa?page=19"> Janssen: I'm certain that it has done so —</a> <a title="June 2021 page 20" href="https://secure.viewer.zmags.com/publication/a11785aa?page=20"> products of cells. So the cellular starting mater</a> <a title="June 2021 page 21" href="https://secure.viewer.zmags.com/publication/a11785aa?page=21"> FOCUS ON... FACILITIES Four Design Fact</a> <a title="June 2021 page 22" href="https://secure.viewer.zmags.com/publication/a11785aa?page=22"> </a> <a title="June 2021 page 23" href="https://secure.viewer.zmags.com/publication/a11785aa?page=23"> parallel, a detailed understanding of production </a> <a title="June 2021 page 24" href="https://secure.viewer.zmags.com/publication/a11785aa?page=24"> Forward thinking Partnering with </a> <a title="June 2021 page 25" href="https://secure.viewer.zmags.com/publication/a11785aa?page=25"> power, uninterruptible power supply (UPS), and pr</a> <a title="June 2021 page 26" href="https://secure.viewer.zmags.com/publication/a11785aa?page=26"> THIS IS PROCESS EVOLUTION SciLog® FD System Prev</a> <a title="June 2021 page 27" href="https://secure.viewer.zmags.com/publication/a11785aa?page=27"> FOCUS ON... MANUFACTURING Toward the Poi</a> <a title="June 2021 page 28" href="https://secure.viewer.zmags.com/publication/a11785aa?page=28"> acute cases, the autologous approach holds a lot </a> <a title="June 2021 page 29" href="https://secure.viewer.zmags.com/publication/a11785aa?page=29"> have good biology; you need good engineering arou</a> <a title="June 2021 page 30" href="https://secure.viewer.zmags.com/publication/a11785aa?page=30"> delivering transformative medicines Exo</a> <a title="June 2021 page 31" href="https://secure.viewer.zmags.com/publication/a11785aa?page=31"> BIOPROCESS TECHNICAL Ligand-Based Exosome Affin</a> <a title="June 2021 page 32" href="https://secure.viewer.zmags.com/publication/a11785aa?page=32"> #CHROMATO GRAPHY EXPERTS EFFICIENTLY PURIFY AN</a> <a title="June 2021 page 33" href="https://secure.viewer.zmags.com/publication/a11785aa?page=33"> Figure 2: Cryoelectron microscopy image of two Pl</a> <a title="June 2021 page 34" href="https://secure.viewer.zmags.com/publication/a11785aa?page=34"> Accelerating Progress & Time to Market </a> <a title="June 2021 page 35" href="https://secure.viewer.zmags.com/publication/a11785aa?page=35"> Table 2: Ligand-based exosome affinity purificati</a> <a title="June 2021 page 36" href="https://secure.viewer.zmags.com/publication/a11785aa?page=36"> Large-Scale Transfection for Virus Production Tr</a> <a title="June 2021 page 37" href="https://secure.viewer.zmags.com/publication/a11785aa?page=37"> Table 3: Summary of EV purification methods again</a> <a title="June 2021 page 38" href="https://secure.viewer.zmags.com/publication/a11785aa?page=38"> and Latest Trends. BioMed. Res. Int. 2018, 2018: </a> <a title="June 2021 page 39" href="https://secure.viewer.zmags.com/publication/a11785aa?page=39"> BIOPROCESS TECHNICAL Measuring Viral Titer in A</a> <a title="June 2021 page 40" href="https://secure.viewer.zmags.com/publication/a11785aa?page=40"> are relative: qPCR technology measures nucleic ac</a> <a title="June 2021 page 41" href="https://secure.viewer.zmags.com/publication/a11785aa?page=41"> how it could be used to resolve the uncertainty p</a> <a title="June 2021 page 42" href="https://secure.viewer.zmags.com/publication/a11785aa?page=42"> Richter-Helm triples production capacity to meet </a> <a title="June 2021 page 43" href="https://secure.viewer.zmags.com/publication/a11785aa?page=43"> BIOPROCESS TECHNICAL The Promise of Artificial</a> <a title="June 2021 page 44" href="https://secure.viewer.zmags.com/publication/a11785aa?page=44"> Figure 1: Pilot system set up (F1 score is the ha</a> <a title="June 2021 page 45" href="https://secure.viewer.zmags.com/publication/a11785aa?page=45"> Figure 2: Bioreactor-integrated model predictive </a> <a title="June 2021 page 46" href="https://secure.viewer.zmags.com/publication/a11785aa?page=46"> Our Solution: Integrated, End-to-end Enabling Pla</a> <a title="June 2021 page 47" href="https://secure.viewer.zmags.com/publication/a11785aa?page=47"> Figure 4: Workflow and timeline of the discoidin </a> <a title="June 2021 page 48" href="https://secure.viewer.zmags.com/publication/a11785aa?page=48"> Pandemic Preparedness: Partnering to Shape Agile </a> <a title="June 2021 page 49" href="https://secure.viewer.zmags.com/publication/a11785aa?page=49"> Figure 5: Nodes and edges comprising protein and </a> <a title="June 2021 page 50" href="https://secure.viewer.zmags.com/publication/a11785aa?page=50"> </a> <a title="June 2021 page 51" href="https://secure.viewer.zmags.com/publication/a11785aa?page=51"> enters a laboratory, clinic, or bioreactor. The A</a> <a title="June 2021 page 52" href="https://secure.viewer.zmags.com/publication/a11785aa?page=52"> Whether it's a vaccine, a recombinant protein or </a> <a title="June 2021 page 53" href="https://secure.viewer.zmags.com/publication/a11785aa?page=53"> BIOPROCESS TECHNICAL Analytical Methods for Cel</a> <a title="June 2021 page 54" href="https://secure.viewer.zmags.com/publication/a11785aa?page=54"> Boost your Host Cell Protein Analytics Help ensur</a> <a title="June 2021 page 55" href="https://secure.viewer.zmags.com/publication/a11785aa?page=55"> Figure 1: Methods validation requirements and ana</a> <a title="June 2021 page 56" href="https://secure.viewer.zmags.com/publication/a11785aa?page=56"> Figure 2: Analytical method lifecycle management </a> <a title="June 2021 page 57" href="https://secure.viewer.zmags.com/publication/a11785aa?page=57"> Figure 3: Control chart and relative potency resu</a> <a title="June 2021 page 58" href="https://secure.viewer.zmags.com/publication/a11785aa?page=58"> </a> <a title="June 2021 page 59" href="https://secure.viewer.zmags.com/publication/a11785aa?page=59"> Figure 4: Immunophenotyping optimization — titrat</a> <a title="June 2021 page 60" href="https://secure.viewer.zmags.com/publication/a11785aa?page=60"> The second “Validation” box summarizes our r</a> <a title="June 2021 page 61" href="https://secure.viewer.zmags.com/publication/a11785aa?page=61"> SUPPLIER SIDE Eradicating the Need for Cold-Cha</a> <a title="June 2021 page 62" href="https://secure.viewer.zmags.com/publication/a11785aa?page=62"> viruses, and fungi). Currently, drug products mus</a> <a title="June 2021 page 63" href="https://secure.viewer.zmags.com/publication/a11785aa?page=63"> Figure 4: Biologic 2 recovery (NS = not sterilize</a> <a title="June 2021 page 64" href="https://secure.viewer.zmags.com/publication/a11785aa?page=64"> stability. This method has shown favorable result</a> <a title="June 2021 page 65" href="https://secure.viewer.zmags.com/publication/a11785aa?page=65"> SUPPLIER SIDE A Complete Solution for MSC Therap</a> <a title="June 2021 page 66" href="https://secure.viewer.zmags.com/publication/a11785aa?page=66"> transfer process data from the X-WASH control mod</a> <a title="June 2021 page 67" href="https://secure.viewer.zmags.com/publication/a11785aa?page=67"> at your facility sterile and ready to use. They m</a> <a title="June 2021 page 68" href="https://secure.viewer.zmags.com/publication/a11785aa?page=68"> SUPPLIER SIDE Validation of a Next-Generation S</a> <a title="June 2021 page 69" href="https://secure.viewer.zmags.com/publication/a11785aa?page=69"> Figure 3: Back panel of benchtop (LEFT) and panel</a> <a title="June 2021 page 70" href="https://secure.viewer.zmags.com/publication/a11785aa?page=70"> Highlighted Applications Prefilter </a> <a title="June 2021 page 71" href="https://secure.viewer.zmags.com/publication/a11785aa?page=71"> SUPPLIER SIDE Overcoming Obstacles in AAV Viral </a> <a title="June 2021 page 72" href="https://secure.viewer.zmags.com/publication/a11785aa?page=72"> example, iCELLis fixed-bed bioreactors are used i</a> <a title="June 2021 page 73" href="https://secure.viewer.zmags.com/publication/a11785aa?page=73"> SUPPLIER SIDE Production and Purification of mRN</a> <a title="June 2021 page 74" href="https://secure.viewer.zmags.com/publication/a11785aa?page=74"> Figure 1: IVT analysis after four hours of incuba</a> <a title="June 2021 page 75" href="https://secure.viewer.zmags.com/publication/a11785aa?page=75"> ASK THE EXPERT Selecting the Right Buff</a> <a title="June 2021 page 76" href="https://secure.viewer.zmags.com/publication/a11785aa?page=76"> ASK THE EXPERT buffer in a processing suite. 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