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| Welcome to the redesigned Bioprocess Online newsletter! In addition to having a new look, the newsletter will now be delivered daily, and each issue will focus on a specific topic or topics. Visit your profile page to update your topic preferences and receive only the newsletter(s) of interest to you. |
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FOCUS ON ANALYTICS & QUALITY |
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By Mike Lanewala and Tina Yauger, Clarkston Consulting | The laboratory information management system (LIMS) landscape in 2024 is a dynamic one, driven by accelerating advancements in technology and evolving industry needs. This article shares the four key trends. |
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| Quality By Design And Affinity Chromatography | Article | KBI Biopharma | As more sophisticated protein structures are utilized in complex biologics development, how do we optimize affinity chromatography to ensure higher yields for more efficient biomanufacturing at scale? |
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| Top 3 Megatrends In OT Cybersecurity | Article | Honeywell Process Solutions | Explore the megatrends that are shaping the future of operational technology (OT) cybersecurity, and the strategic measures organizations can take to protect themselves against threats. |
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| EMPQ And Validation Support Services | Case Study | CAI | A growing pharmaceutical/biotech company hired a global consulting firm for a project that required EMPQ services for qualification activities on a newly completed aseptic processing suite. |
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ANALYTICS & QUALITY SOLUTIONS |
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By Kamil Shaik and Guriqbal Singh, RegWeb | Drug developers aspire to treat patients globally, but navigating diverse regulatory structures around the world gets tricky. These consultants offer a primer on the regulatory bodies of the world. |
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| Response To FDA Black Box Warning | White Paper | Theragent | The FDA has launched an investigation into the risk of T-cell malignancies following CAR-T cell immunotherapies. Review the key points of this announcement concerning the CGT research community. |
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| ICH Q14 101: Applying AQbD To CMC For Regulatory Success | E-Book | Labcorp Biopharmaceutical CMC Services | ICH Q14 provides comprehensive guidance on analytical procedure development, offering an invaluable framework for ensuring the development of regulatorily compliant analytical procedures. |
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| U.S. Biopharma Workforce Partnership Conference: April 17 and 18 | Registration is open for a novel talent acquisition partnership conference this April orchestrated by the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). The two-day conference in Boston brings together the industry with a myriad of biopharma-savvy universities, community colleges, and non-profits. The conference will be of keen interest to technical hiring managers, recruiters, and HR professionals. |
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