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
- Fine-tuning Analytical Development Strategies For Every Phase
- Navigating Grades And Sources Of Materials In Drug Manufacturing
- 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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Transitioning From Using RUO To cGMP Chemicals For Clinical Trials
Learn about the common challenges and risks associated with accelerating your molecule's timeline from lab to clinic, along with important supply chain considerations for emerging biopharma companies.
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Selecting Optimal Chromatography Resins To Support mAb Purification10/2/2023
Discover key considerations when selecting resin options for mAb purification, including alternatives to the conventional affinity capture step.
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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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Switching From Vials To PFS And Intravenous To Subcutaneous Formulations7/25/2023
Learn about formulation development challenges for prefilled syringes as well as considerations for reducing the time it takes to launch safer, more convenient, and cost-effective products for the patient.
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Exploring The Future Of Viral Vector Development And Production1/17/2024
The demand for viral vectors continues to grow, making addressing the challenges related to their manufacturing and scale-up increasingly critical.
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Critical Considerations For Buffer Preparation8/7/2023
Learn about the steps of buffer development, supply approach and strategy selection, choosing between in-house and outsourcing buffer activities, and other related buffer use topics.
BIOPROCESSING APP NOTES & CASE STUDIES
- Novel Engineered Plasmids, Optimized HEK293 Cell Line For AAV Productivity
- Performance Of A Fully Automated, Single-Use TFF System In ADC Processes
- Achieve Fast And Efficient Isolation Of Exosomes From Stem Cells
- Fast, Flexible, And Intelligent Solutions For Buffer Preparation
- Advances In Bioreactor Washing
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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