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Aqueous Cleaning Processes
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E-Book | By Michael Moussourakis, Jeff Phillips, et al., TCP Analytical
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What does the BATH-O-CARD acronym represent, and how can it help you during your aqueous cleaning process?
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By Louis Garguilo, chief editor, Outsourced Pharma
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In April, the FDA again informed us that the Bloomington, Indiana facilities — owned by Catalent until their December 2024 sale to Novo Nordisk — still haven't resolved their quality issues, adding to an inspection and remediation history years in the making. How are we witnessing this at a U.S. facility run by a name-brand CDMO and then Big Pharma? Catalent, for its part, wants to stop "inaccuracies in media coverage." Here's analysis from our own Chief Editor Louis Garguilo, with perspective from an experienced pharma professional.
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INDUSTRY INSIGHTS CONTINUED
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Why Upstream-Downstream Alignment Determines Success
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Article | By Stephanie Wickham, Ph.D., LOTTE Biologics
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Aligning early upstream choices, downstream purification, and analytical testing prevents scale-up delays, reduces process variability, and protects timelines for complex biologics.
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Starting With The End In Mind
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White Paper | By Pablo Gutiérrez Gómez, 53Biologics
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Complex biologics need scalable, GMP-ready development from the start. Early decisions, scientific continuity, and strong partnerships help reduce delays and rework.
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Scaling Clinical To Commercial With One CDMO
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Article | Afton Scientific
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Deciding whether to stay or switch CDMOs means balancing continuity benefits, capability gaps, and transfer costs to ensure efficient, low-risk clinical-to-commercial progress.
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N-1 Perfusion Strategies For Commercial-Ready Biologics
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Webinar | Boehringer Ingelheim Biopharmaceuticals GmbH
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Uncover how modular N-1 perfusion strategies shorten seed train timelines and reduce facility strain — enabling upstream processes that scale efficiently and reliably for commercial manufacturing.
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OUTSOURCED PHARMA CAPABILITIES UPDATE
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CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capabilities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.
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| Connect With Outsourced Pharma: |
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