Continuous processing adoption so far has been slow; however, market research shows demand and capacity will grow significantly over the next four years.
- Quick Takes From Takeda Austria’s Annex 1 Rollout
- 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
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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Quick Takes From Takeda Austria’s Annex 1 Rollout
At ISPE's 2024 Aseptic Conference, Takeda Austria's site head spoke about lessons learned from Annex 1 implementation. We caught up with her and asked for the highlights.
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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>.
BIOPROCESSING WHITE PAPERS
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A New Challenge For Quality Experts – The Data Quality Concept
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.
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Assessing Liquid Transfer Performance With Reliable, Ready-To-Use Reagents11/13/2023
See how specially formulated dye-containing solutions replicate the liquid transfer properties of several commercially available PCR master mixes, making them reliable and ready-to-use reagents for determining liquid transfer performance.
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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.
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Move Your Gene Therapy From Strategy To Reality8/30/2022
Explore how optimizing your process with an end-to-end integrated solution can reduce costs, increase speed to market and get your final gene therapy product within reach of patients.
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Biosafety Testing And Quality Control Requirements For Lentiviral Vectors9/26/2022
Learn more about manufacturing principles of LV vectors as well as testing requirement regulatory considerations with a particular focus on the replication competent virus assay and infectious titer assay.
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Navigating The Regulatory Maze: Fundamentals For Drug Development7/15/2022
Learn about key regulatory concepts and ways to accelerate and reduce risk throughout the drug development journey.
BIOPROCESSING APP NOTES & CASE STUDIES
- A Novel Downstream Processing System For Cell Line Development Workflows
- How Takeda Streamlines Assay Transfer And Troubleshooting
- Process Transfer Of CHO Cultivations
- Collaborate With Sponsors, Ensure Regulatory Compliance, And Secure Product Quality
- Using High Cell Density Cryopreservation For Seed Train Intensification
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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