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
-
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
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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
-
Move Your Gene Therapy From Strategy To Reality
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.
-
Systems For Shop Floor Automation And Digitization9/30/2022
We review an automation system that is based on a standard technology platform, with standardized hardware, networking, and software elements and is designed to securely connect to end-user networks.
-
A Framework For Controlling Variability And Optimizing Assay Performance11/13/2023
By employing a process optimization approach to assay development, you can improve overall assay performance.
-
Host Cell Protein Analysis: Immunoassays3/10/2023
Learn about host cell proteins (HCPs) and the sensitive and specific orthogonal methods necessary to identify individual HCP impurities that persist through DS purification processes.
-
Key Stages In mRNA-Based Therapeutic Development9/13/2022
Learn how planning a product development strategy early on with a technology partner who has deep expertise and technical knowledge of genomic medicines can address uncertainties from the outset.
-
3D Manufacturing Of Therapeutic hMSCs7/18/2022
Discover how our microcarrier-based technology harvests hMSCs while showing high proliferation capacity, expression of hMSC-specific markers, significant trilineage differentiation potential, and strong immunomodulatory and angiogenic potency.
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.
More Content CollectionsFEATURED PRODUCTS AND SERVICES
ON-DEMAND WEBINARS
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 03.28.24 -- Optimize Your Drug Development With GPS Engineering
- 03.28.24 -- Optimize Your Drug Development With GPS Engineering
- 03.27.24 -- Is Your Data Ready For Pharma 4.0?
- 03.27.24 -- Decoding The FDA's Draft Guidance On Computer Software Assurance For Medical Devices & Bio/Pharma
- 03.26.24 -- Optimizing CGT Development: Modular Approaches And Cryopreservation Insights