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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A Comparative Analysis Of Mixing Characterization Methods
In the bioprocessing industry, there is no single, standard method for measuring mixing performance. Here, we investigate the four most widely used methods for measuring mixing time.
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How Can DOE Help Optimize Your Purification Workflow?6/9/2023
Improve your downstream purification process and utilize design of experiments (DOE) to help in selecting appropriate chromatographic techniques and account for variation among mAbs.
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Reliable Osmolality Testing Of High Concentration mAb Formulations5/19/2022
Osmolality testing has several bioprocessing applications, and new use cases are constantly emerging. This paper evaluates two osmometers for measuring concentrated protein formulations.
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An Experienced CDMO Can Be A Differentiator In The Rapidly Growing Biologics Market12/14/2023
Biotech and biopharma developers are increasingly relying on outsourcing partners to meet both clinical and commercial research, development, and production needs. CDMOs that provide end-to-end services, including secure supply chains, can help biologics developers meet accelerated timelines and establish a real competitive advantage in today’s competitive market.
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Cryopreservation Of Cells: Preserving Cells For Future Use9/11/2023
Take a closer look at the process of cryopreservation, which role it plays for cell banking, and which challenges have to be overcome to reach the successful cryopreservation of cells.
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Calculating Your Business Case For Continuous Manufacturing6/16/2023
Review key considerations as a Pharmatech Associates expert introduces a useful financial equation to calculate amortization to develop the business case for PCM and provides a few real-world cases.
BIOPROCESSING APP NOTES & CASE STUDIES
- How To Choose The Correct Syringe Filter For Analytical Sample Preparation
- Optimizing Accuracy Performance On A Beckman Coulter Biomek
- QC Lab Program And Project Management
- Enhanced T Cell Expansion While Maintaining Early Memory Cell Phenotype
- Rapid Mycoplasma Detection For Bioproduction Sample Testing
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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