The answer might be sooner than you think and entail more transparency than you're used to.
- 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
- AI And Pharmaceutical Development: WHO Calls For Ethical Framework, Good Governance
- Digitizing CMC Knowledge Management
- Managing Supply Chain Risks Using Relational Risk Analysis
- When Does GMP Matter In Non-GMP Settings?
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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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.
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Managing Supply Chain Risks Using Relational Risk Analysis
In the bio/pharma and medical device industries, you can easily model, understand, and manage supply chain risks using relational risk analysis. Here's how.
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When Does GMP Matter In Non-GMP Settings?
Would you ever need to follow GMP standards in workspaces where GMP is not required or possible? This article digs into why, when, and how to follow the principles of GMP.
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What Really Happens When A Cell Therapy Supply Chain Fails?
A freezer left unpowered can have devastating effects on delicate supply chains. These true stories led to tough lessons for biotech companies producing personalized medicine.
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Designing Highly Agile Bio/Pharma Manufacturing Facilities
In bio/pharma, agile manufacturing is achieved through multipurpose designs that support a variety of unit operations manipulated and operated as independent yet connected modules.
BIOPROCESSING WHITE PAPERS
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Perspectives On The Adoption Of Fully Closed Processing
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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The Business Case For Pharmaceutical Continuous Manufacturing6/2/2023
Examine a step-by-step approach outlining the business cases that support adopting continuous manufacturing, with considerations for innovators, generics manufacturers, CDMOs, and OTC suppliers.
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Process Development Considerations For RNA-LNP Therapeutics9/13/2022
Here, we highlight three important process considerations across the RNA-LNP manufacturing workflow which includes limit size behavior, in-line dilution and downstream tangential flow filtration (TFF).
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Generation Of Stable CHO Cell Lines For Protein Production3/22/2024
By following the five steps of a specialized protocol, exceptional yields and stable cell lines can be achieved in CHO cells using antibiotic selection.
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Impact Of Immunogenicity On Efficacy And Safety Of Biosimilars2/9/2024
The presence of anti-drug antibodies (ADAs) can affect the effectiveness and safety of biologic drugs. Read why regulatory agencies emphasize the need for extensive immunogenicity evaluation in biosimilar development.
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A Framework For Controlling Variability And Optimizing Assay Performance11/13/2023
By employing a process optimization approach to assay development, you can improve overall assay performance.
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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INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 04.18.24 -- Bringing Therapies To Patients With Speed And Confidence
- 04.18.24 -- Process Mapping For More Effective Knowledge Management
- 04.17.24 -- Optimizing Drug Delivery Systems For Complex Biologics
- 04.17.24 -- Leverage Innovative Assays And Monitoring To Improve mAb Production
- 04.17.24 -- A Novel Approach To Managing Risks In Aseptic Processing Of Cell & Gene Therapies