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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![medical engineers examining equipment-GettyImages-542939804]( "Doubling Down On Biopharma’s Growing Skills Drought")
Doubling Down On Biopharma’s Growing Skills DroughtThe 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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![Glass medical ampoule vial for injection-GettyImages-1310700059]( "FDA Publishes Final Guidance On Reporting Listed Drug Amounts")
FDA Publishes Final Guidance On Reporting Listed Drug AmountsDespite 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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![Robot Arm holding microchip-GettyImages-1309584123]( "2024 CIO Survey Reveals IT Budgets, AI Priorities For Life Sciences Companies")
2024 CIO Survey Reveals IT Budgets, AI Priorities For Life Sciences CompaniesClarkston 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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![World health organization-GettyImages-1209486927]( "AI And Pharmaceutical Development: WHO Calls For Ethical Framework, Good Governance")
AI And Pharmaceutical Development: WHO Calls For Ethical Framework, Good GovernanceThe 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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![Creative-smart thinking-GettyImages-1344939844]( "Digitizing CMC Knowledge Management")
Digitizing CMC Knowledge ManagementSystems 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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![Getty-1652511983-supply-chain-management]( "Managing Supply Chain Risks Using Relational Risk Analysis")
Managing Supply Chain Risks Using Relational Risk AnalysisIn 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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![cell culture dish-GettyImages-1592382581]( "When Does GMP Matter In Non-GMP Settings?")
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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![Box damaged in shipping-GettyImages-510694525]( "What Really Happens When A Cell Therapy Supply Chain Fails?")
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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![GettyImages-929029342]( "Designing Highly Agile Bio/Pharma Manufacturing Facilities")
Designing Highly Agile Bio/Pharma Manufacturing FacilitiesIn 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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![Lipid nanoparticle mRNA vaccine-GettyImages-1418152448]( "Advancing A LNP Formulation To Clinical And Commercial Manufacturing")
Advancing A LNP Formulation To Clinical And Commercial ManufacturingLipid selection impacts the final LNP drug product and the LNP process. Review critical quality considerations for lipids and the process requirements for successful commercial-scale manufacturing.
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State-Of-The-Art Bispecific Antibody Development10/11/2022
The promise of bispecific antibodies stems from their off-the-shelf nature and ability to bind to two or more different targets or epitopes, thereby performing multiple functions.
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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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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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Cost Savings And Economic Benefits Of Perfusion Bioprocessing4/18/2022
Discuss advances in biopharmaceutical manufacturing that make perfusion an increasingly popular choice, as well as the economic benefits and concerns surrounding the method.
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How Can The Industry Drive Down The Cost Of Viral Gene Therapies?4/5/2023
This article discusses how a combination of optimizing your process development, and process intensification can help drive the cost of dose down.
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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