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<br /> BioProcess<br /> International<br /> DIGITAL EDITION<br /> ARCHIVE<br /> BioProcess<br /> International<br /> ASSAY<br /> DEVELOPMENT<br /> March 2021<br /> Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1<br /> Technologies Converge in Biopharmaceutical<br /> Laboratories<br /> ESTABLISHING AND Cheryl Scott<br /> Automation of Potency Assays . . . . . . . . . . . . . . . . . . 4<br /> TRACKING QUALIT Y A Strategic Journey<br /> Maribel Rios and Cheryl Scott, with Hermann Beck<br /> Host-Cell–Protein Assay Development . . . . . . . . . . . 9<br /> OF BIOLOGICS Managing Risks with Evolving Technologies<a title="March 2021 - Featured Report page 1" href="https://secure.viewer.zmags.com/publication/dd0da5aa?page=1"> BioProcess International DIGITAL EDITION ARCHIVE</a> <a title="March 2021 - Featured Report page 2" href="https://secure.viewer.zmags.com/publication/dd0da5aa?page=2"> BioProcess International ASSAY DEVELOPMENT Ma</a> <a title="March 2021 - Featured Report page 3" href="https://secure.viewer.zmags.com/publication/dd0da5aa?page=3"> ACCELERATED BIOLOGICS TESTING Technical excelle</a> <a title="March 2021 - Featured Report page 4" href="https://secure.viewer.zmags.com/publication/dd0da5aa?page=4"> Introduction Technologies Converge in Biopharmace</a> <a title="March 2021 - Featured Report page 5" href="https://secure.viewer.zmags.com/publication/dd0da5aa?page=5"> and/or cell-based assays) and capsid packing rati</a> <a title="March 2021 - Featured Report page 6" href="https://secure.viewer.zmags.com/publication/dd0da5aa?page=6"> such as yours? Some of the most significant gaps </a> <a title="March 2021 - Featured Report page 7" href="https://secure.viewer.zmags.com/publication/dd0da5aa?page=7"> Automation of Potency Assays A Strategic Journey</a> <a title="March 2021 - Featured Report page 8" href="https://secure.viewer.zmags.com/publication/dd0da5aa?page=8"> Figure 2: The Roche global bioassay automation te</a> <a title="March 2021 - Featured Report page 9" href="https://secure.viewer.zmags.com/publication/dd0da5aa?page=9"> Figure 4: Finding equivalency; on visual inspecti</a> <a title="March 2021 - Featured Report page 10" href="https://secure.viewer.zmags.com/publication/dd0da5aa?page=10"> REQUIREMENTS OF 21 CFR 11 Audit trail Change con</a> <a title="March 2021 - Featured Report page 11" href="https://secure.viewer.zmags.com/publication/dd0da5aa?page=11"> The topic of automation is polarizing, Beck </a> <a title="March 2021 - Featured Report page 12" href="https://secure.viewer.zmags.com/publication/dd0da5aa?page=12"> HCP Assay Development Managing Risks with Evolvi</a> <a title="March 2021 - Featured Report page 13" href="https://secure.viewer.zmags.com/publication/dd0da5aa?page=13"> development? MS and ELISA are very orthogonal tec</a> <a title="March 2021 - Featured Report page 14" href="https://secure.viewer.zmags.com/publication/dd0da5aa?page=14"> And around the world, people's knowledge an</a> <a title="March 2021 - Featured Report page 15" href="https://secure.viewer.zmags.com/publication/dd0da5aa?page=15"> application of what limit of detection (LoD) can </a> <a title="March 2021 - Featured Report page 16" href="https://secure.viewer.zmags.com/publication/dd0da5aa?page=16"> commercial specification, I wouldn't go as high a</a> <a title="March 2021 - Featured Report page 17" href="https://secure.viewer.zmags.com/publication/dd0da5aa?page=17"> drive low-affinity interactions that aren't repre</a> <a title="March 2021 - Featured Report page 18" href="https://secure.viewer.zmags.com/publication/dd0da5aa?page=18"> cell-protein-risk-management-and-control-during-b</a> <a title="March 2021 - Featured Report page 19" href="https://secure.viewer.zmags.com/publication/dd0da5aa?page=19"> Stability Testing Monitoring Biological Product </a> <a title="March 2021 - Featured Report page 20" href="https://secure.viewer.zmags.com/publication/dd0da5aa?page=20"> products from basic high-temperature modeling stu</a> <a title="March 2021 - Featured Report page 21" href="https://secure.viewer.zmags.com/publication/dd0da5aa?page=21"> products (1). It includes testing for product-rel</a> <a title="March 2021 - Featured Report page 22" href="https://secure.viewer.zmags.com/publication/dd0da5aa?page=22"> information. The Parenteral Drug Association (PDA</a> <a title="March 2021 - Featured Report page 23" href="https://secure.viewer.zmags.com/publication/dd0da5aa?page=23"> Geneva, Switzerland, 2011; https://www.who.int/me</a> <a title="March 2021 - Featured Report page 24" href="https://secure.viewer.zmags.com/publication/dd0da5aa?page=24"> BioProcess International</a> <a title="March 2021 - Featured Report page 25" href="https://secure.viewer.zmags.com/publication/dd0da5aa?page=25"> SECURE YOUR VISIT ROCKLAND-INC.COM/HCP </a>