Knowledge management — it’s not just a soulless exercise. In the last part of his series, Hirsh helps bridge the gap between compliance and business needs.
- Developing A Process Performance Qualification Master Plan For Gene Therapies
- What Time Is Best To Bring My CDMO On Board?
- Single Use In Biopharma: Beyond Savings & Sustainability
- Unpacking The Importance Of Lipid Nanoparticle Production Platforms
- Cell Counting Is Growing More Important Amid Advanced Therapy’s Rise
- FDA Publishes Final Guidance On Reporting Listed Drug Amounts
- 2024 CIO Survey Reveals IT Budgets, AI Priorities For Life Sciences Companies
EDITOR'S DESK
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Doubling Down On Biopharma’s Growing Skills Drought
The biopharmaceutical industry is building manufacturing capacity at breakneck speed. According to PhRMA, there are 1,580-and-counting biopharma manufacturing facilities in the U.S. alone. Problem is, we're way short on filling those facilities with skilled labor. NIIMBL wants to change that. Here's how, and a great opportunity for big pharma, biotech sponsors, CDMOs, academics, and more to help.
The career of Debra Weiss, RN, MSN, and COO at the biopharma Gates Medical Research Institute (Gates MRI), offers a case study in creating success through service-oriented leadership.
Check out the results of DeciBio's Antibody-Drug Conjugates 2024 Industry Survey, which predict another bullish year for the growing modality.
The U.S. imported $6.95 billion worth of pharmaceuticals from China in 2022. That was 8x the amount we imported in 2021. A proposed Act of Congress puts that supply, and U.S. biotech itself, in serious peril.
In the U.K., a professor at the University of Birmingham is using virtual reality (VR) to help address the growing biomanufacturing skills shortage — using virtual reality (VR).
GUEST COLUMNISTS
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Developing A Process Performance Qualification Master Plan For Gene Therapies
This article provides considerations and a framework for a Process Performance Qualification Master Plan in the gene therapy industry. It is useful for sponsors with any level of experience.
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What Time Is Best To Bring My CDMO On Board?
The answer might be sooner than you think and entail more transparency than you're used to.
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Unpacking The Importance Of Lipid Nanoparticle Production Platforms
Batch processing platforms for LNPs lack efficiency, appropriate controls, and yield optimization. Continuous manufacturing platforms may address some of those issues.
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Cell Counting Is Growing More Important Amid Advanced Therapy’s Rise
You can't improve what you don't measure. This discussion explores advances in cell counting technology and the growing number of ways it aids the biotech industry and beyond.
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FDA Publishes Final Guidance On Reporting Listed Drug Amounts
Despite earlier efforts to shore up the U.S. drug supply chain, COVID-19 still brought shortages. A new FDA reporting system aims to reduce future supply risks.
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2024 CIO Survey Reveals IT Budgets, AI Priorities For Life Sciences Companies
Clarkston Consulting conducted its third annual Chief Information Officer (CIO) Survey to understand IT budgets of life sciences companies, how AI priorities fit into those budgets, and more.
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AI And Pharmaceutical Development: WHO Calls For Ethical Framework, Good Governance
The World Health Organization (WHO) recently released a document titled Benefits and risks of using artificial intelligence for pharmaceutical development and delivery describing the ethical issues and governance considerations for using AI in drug discovery, preclinical development, and clinical trials.
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Digitizing CMC Knowledge Management
Systems that enhance know-how retention stretch from utterly simple to enterprise-scale. Here are some ideas for incorporating them into your knowledge management strategy.
BIOPROCESSING WHITE PAPERS
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Navigating Your Digital Journey To AI Success
The first critical step in your digital journey, before implementing AI, is to ensure you’re at the right level of digital maturity.
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Developing A Scalable RNA-LNP Drug Product For Clinical Translation9/22/2022
Accelerate essential process development activities with instrumentation solution allowing for highly reproducible and scalable production of RNA-LNPs.
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A Dual-Dye Ratiometric Photometry System For Multichannel Verification11/13/2023
Explore the technical and scientific application of dual-dye ratiometric photometry in microtiter plates, upon which a multichannel verification system is based.
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Expectations On The Pathway To GMP For Gene-Modified Cell Therapies6/21/2023
Learn how a robust understanding of the RNP’s critical process parameters and CQAs is crucial for ensuring product consistency, enhancing patient safety, and maintaining regulatory compliance.
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Perspectives On The Adoption Of Fully Closed Processing1/16/2024
In this study, industry experts share their perspectives and plans related to the implementation of fully closed processing. Explore the drivers and challenges of fully closed processing and more.
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Cell Line Development: The Linchpin In Successful Biotherapeutic Development1/4/2024
Review key factors for building a reliable CLD strategy and learn how the right CDMO can help you achieve the high quality, high yield, and speed needed to successfully bring a biologic to market.
BIOPROCESSING APP NOTES & CASE STUDIES
BIOPROCESS ONLINE CONTENT COLLECTIONS
This collection of articles, produced through a partnership between MilliporeSigma and Bioprocess Online, highlights the need for ongoing investment in resilient biomanufacturing capacity and supply chains to ensure the reliable delivery of health technologies like vaccines, even during crisis conditions.
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ON-DEMAND WEBINARS
- Culturing And Characterizing Organoids And Cancer Spheroids
- How To Get Started With Organ-On-A-Chip Technology
- De-Risking The Aseptic Drug-Filling Process And Optimizing Production
- Process Development Optimization For GMP CAR-T Manufacturing
- ChipChat With Emulate: Answering Your Organ-Chip Questions Live
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 04.23.24 -- Genetic Stability Simplified. One Method, Multiple Answers.
- 04.23.24 -- Business Of Biotech Newsletter
- 04.23.24 -- Novel Approaches In Chromatography Process Development
- 04.23.24 -- Women In Biotech With Bill & Melinda Gates MRI's Piper Trelstad, Ph.D.
- 04.22.24 -- Maximizing Biologics Potential Through Integrated Services For Faster Timelines