A supply chain pro discusses three of the greatest challenges in clinical trial supply management for rare diseases and strategies to overcome them.
- Navigating Grades And Sources Of Materials In Drug Manufacturing
- Fine-tuning Analytical Development Strategies For Every Phase
- Improving AAV Purity Upstream With PCL Manufacturing
- A Guide To Proactive Supplier Management In The Pharma/Biotech Industry
- How To Measure Cell Density In Real Time With Soft Sensors
- How To Prevent And Manage Temperature Excursions In Clinical Trials
- Process Development With “The End In Mind” For Startups
EDITOR'S DESK
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Debra Weiss, RN: Big Impact In Small, Non-Profit Bio
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).
By modifying CD4 T cells using miRNA, Jeff Galvin’s company thinks it can deliver a functional cure for HIV. Here’s the ongoing story of Addimmune and its unique clinical strategy.
GUEST COLUMNISTS
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Fine-tuning Analytical Development Strategies For Every Phase
Analytical challenges morph phase-by-phase during drug development. Three Novartis scientists describe a platform approach based on guidance from the ICH and USP.
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Navigating Grades And Sources Of Materials In Drug Manufacturing
From raw materials to finished dosage forms, understanding material quality is essential in drug manufacturing. This article examines how material grades and sources guide selection for optimal safety and functionality.
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A Guide To Proactive Supplier Management In The Pharma/Biotech Industry
Proactively mitigate supply disruptions with strategic supplier selection and diversification, effective communication, risk management, quality assurance, and more.
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How To Measure Cell Density In Real Time With Soft Sensors
Soft sensors can enable real-time monitoring of key process variables, including viable cell density. Here's how one team at Takeda put them to use.
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How To Prevent And Manage Temperature Excursions In Clinical Trials
Temperature excursions can have devastating effects on drug product for clinical trials. Here are some ways to avoid them and protect the cold chain.
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Process Development With “The End In Mind” For Startups
We encounter the term “the end in mind” in product development frequently, but many are unsure what it really means and when it matters. This article sheds light.
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Considerations For Robust Implementation Of The Multi-Attribute Method
USP experts explore implementation strategies for the multi-attribute method, including best practices summarized from the USP’s General Chapter <1060>.
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2024 LIMS Trends
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.
BIOPROCESSING WHITE PAPERS
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Cost Savings And Economic Benefits Of Perfusion Bioprocessing
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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Manufacturing Challenges With High Concentration Biologics3/18/2024
Explore key process operations, some of the challenges in manufacturing high-concentration biologics, and factors to consider for process optimization.
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The Roles Of Operational Readiness, Capital Projects In Drug Manufacturing8/31/2022
Read more about what a facility needs to achieve operational readiness and the necessary steps to take to be at full scale production when the “go” button is hit.
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Assurance Of Clonality For Biotherapeutics10/13/2022
The clonality of Master Cell Banks (MCBs) for production cell lines is a key requirement in biotherapeutics manufacturing. Learn how new devices help optimize the cloning process.
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Orthogonal Methods To Understand And Define CQAs Of AAV Therapies2/24/2023
An essential part of AAV vector production is the characterization of potential CQAs. Learn about novel, robust, and orthogonal methods that can be used to assess identity, purity, and residuals.
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A New Challenge For Quality Experts – The Data Quality Concept4/20/2022
Quality experts are facing the challenge of rethinking their roles and redesigning the quality systems of their pharmaceutical companies to be based on the concepts of data quality.
BIOPROCESSING APP NOTES & CASE STUDIES
- Transition To Closed Processing Systems For Cell Expansion And Banking
- Chromatography Solutions For AAV Full And Empty Capsid Separation
- Process Optimization And Scalability Evaluation Of Pellicon® Capsules For SPTFF Of mAb-Based Biomolecules
- mAbs Biotech Recognizes Value In Expertise, Track Record
- Alternative To A Three-Step Monoclonal Antibody Purification Process
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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