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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Sterile Filtration And Quality Risk Management
Process control is essential for manufacturing sterile products. Explore the role of filtration for bioburden control in quality risk management and contamination control strategies.
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Taking Charge Of Your Stability Program10/5/2022
Conducting stability studies is a critical aspect of the drug development process. Learn how consolidating stability testing with a single partner offers improved efficiency, reduced risk, and more.
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Collaborating With A CMO To Bring Your Sterile Injectable Product To Market2/15/2023
Review considerations for collaborating with a fill/finish CMO, including CMO selection, Request for Proposal (RFP) delivery, proposal review, and project award.
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The MAPPs Assay: A Useful Tool For The Assessment Of Immunogenicity1/4/2024
Explore how MAPPS demonstrates promise as a valuable tool for comprehensive immunogenicity assessment in therapeutic protein development, contributing to safer and more effective biologics.
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Validation Master Plan For Filtration Systems Used In Aseptic Processing1/13/2023
Regulatory guidance provides a framework for aseptic processing that ensures patient safety. Learn about the best practices for validating performance of critical filtration systems used in aseptic processing.
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The Heroes Of Vaccine Development: Lipid Nanoparticles2/8/2024
Lipid nanoparticles (LNPs) have played a crucial role in COVID-19 vaccine development as efficient mRNA delivery systems, exhibiting versatility and effectiveness in accelerating the process.
BIOPROCESSING APP NOTES & CASE STUDIES
- Viscosity-Reducing Excipients For Protein Formulation
- Optimizing DMSO Concentration And Freezing Technique For High Cell Density Cryopreservation In Upstream Bioprocessing
- Find The Right T Cell Expansion And Phenotype Balance For Cell Therapy
- Achieve Manufacturing Scale For Your Viral Vector Production
- Rapid Separation Of Circular RNA Using An mRNA Analysis Kit
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.
More Content CollectionsFEATURED PRODUCTS AND SERVICES
ON-DEMAND WEBINARS
- Unlocking The Potential Of Your Sterile Injectables With Exact SI-ence
- Enhancing Efficiency And Accuracy In Cell Line Development
- Assess The Impact Of Conjugation With Multi-Parameter Stability Characterization
- Instant Implementation Of Raman-Based Monitoring
- Why You Need Monoliths To Purify Your Biomolecules
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 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
- 04.16.24 -- Facing Purification Bottlenecks? Streamline Your DSP With Next-Gen Tools
- 04.16.24 -- Streamline Oligo Production With A Comprehensive Equipment Range