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.
- A Structured Approach To Regulatory Information Management Vendor Selection
- Getting To Know MAM, The New Quality Control Strategy On the Block
- Serial Success With Triumvira's Rob Williamson
- What Proposed Plasmid DNA Standards Say For GMP/Non-GMP Production
- Debra Weiss, RN: Big Impact In Small, Non-Profit Bio
- Navigating China's Biologics Approval And Accelerated Pathways
- Shocking! Biotech Facilities Don't Maintain Themselves
EDITOR'S DESK
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U.S. Biotech Is In For A Protracted Divorce From China
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.
You’ve heard San Francisco was buzzing with cautious optimism last month. You’ve seen the M&A activity that’s buoying spirits and you know inflation and interest rates are stabilizing, if not improving. You may not have considered these three trendlines, offered by a guy who spent his time at JPM doing more listening than anything.
Despite the continuation of a poor funding climate in biotech, 2023 was a big year for antibody-drug conjugates (ADCs).
GUEST COLUMNISTS
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Getting To Know MAM, The New Quality Control Strategy On the Block
When characterizing PQAs, the multi-attribute method offers a one-stop shop for analysis. This article explores technical considerations for this emerging strategy.
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What Proposed Plasmid DNA Standards Say For GMP/Non-GMP Production
Today’s standards for plasmid DNA production lack specificity, and manufacturers have been clamoring for more. In late 2023, USP published draft General Chapter <1040> to help fill in the cracks.
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Navigating China's Biologics Approval And Accelerated Pathways
Pharma companies doing business in China have four key routes to register drugs faster than the standard ways. This discussion breaks down accelerated pathways and offers tips on how to approach them.
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Shocking! Biotech Facilities Don't Maintain Themselves
Don't get trapped in the misconception that only biomanufacturing process systems need maintenance. Here are some real-life examples of facility maintenance programs gone wrong.
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Green Gains In Biopharma Without Closing Facilities?
Going green is virtually impossible for biopharma companies with legacy systems, but going greener might be within reach. Here are some ideas to get started.
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Comparability Considerations For mRNA Product Development
Given the mRNA-based products' variability and unique challenges, you may need to modify the standard comparability approach. Let’s discuss strategies for any development stage.
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FDA’s Updated Guidance On Human Genome Editing: New Implications & Remaining Questions
On Jan. 29, 2024, the FDA released the final version of the guidance document on human gene therapy products incorporating genome editing. This article shares what changed between the draft and now final version of the guidance, and what open questions remain for the industry and scientific community to help resolve.
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How Pharma 4.0 Can Unlock The Full Potential Of External Manufacturing
To address today's challenges and other headwinds, pharma/biotech organizations and CMO/CDMO partners need to re-evaluate and improve externalized operating models. Consider further investing in digitalizing collaboration processes as part of operational excellence and digital transformation road map efforts.
BIOPROCESSING WHITE PAPERS
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Data Utilization For Advanced Analytics And Near Real-Time Monitoring
Control, monitor, and analyze equipment, processes, results, and data in near real time and make data-driven decisions at both the process and plant levels.
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The Latest Trends In The Prevention And Treatment Of Cervical Cancer2/8/2024
Unearth what immune checkpoint inhibitors are showing promise in treating cervical cancer and how advancements in these treatments paired with additional prevention strategies are improving patient outcomes.
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Potent Rifampicin Derivatives Can Clear MRSA Infections At Single Low Doses When Concomitantly Dosed With Vancomycin1/4/2024
Multidrug-resistant bacteria are rendering antibiotics ineffective. Review preclinical results of a potent macrocycle derivative and why collaboration is crucial to transition discoveries into treatments.
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Review Of Annex 1 2022: Environmental Monitoring Changes9/13/2022
We highlight the changes to the new revision of the EU GMP Annex 1 regulatory standard for sterile drug products that was released in August 2022.
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Trends In The Outsourcing Of Development And Manufacturing Of Biologics3/18/2022
Read more on trends related to outsourcing and share what attributes of an outsourcing partner are sought by developers and manufacturers of biopharmaceuticals.
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7 Tips To Improve OT Cybersecurity For Life Sciences11/22/2023
Leverage the insights of cybersecurity specialists and industry experts to gain a broader context for more informed decision-making regarding actions and next steps to improve OT cybersecurity.
BIOPROCESSING APP NOTES & CASE STUDIES
- Optimizing DMSO Concentration And Freezing Technique For High Cell Density Cryopreservation In Upstream Bioprocessing
- Next-Generation Single-Use Harvest Solutions
- Optimizing Process Loads For VHP Decontamination
- Optimizing Kinetics Assays To Avoid Avidity Effects
- Implementing High Cell Density Cryopreservation In Your Seed Train
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
- Identify And Quantify AAV Fill States Using Analytical Ultracentrifugation
- De-Risking Development With Analytical Characterization Capabilities
- Hybrid Modeling Approach For Rapid Clone Selection In Perfusion Processes
- Idea To Clinic: Accelerate Your Manufacturing Timeline To FIH Studies
- Selecting Container Closure Systems With Confidence: Lyophilization
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 03.18.24 -- Relational Risk Analysis For The Bio/Pharma Industry
- 03.15.24 -- Tangential Flow Filtration 101 — The Tech, The Need, And The Market
- 03.13.24 -- Explore Revolutionary Research Shaping Medicine
- 03.13.24 -- FDA Issues Draft Guidance For Cell & Gene Therapy Potency Assurance
- 03.12.24 -- Regulatory & GMP Manufacturing Insights Into mRNA-LNP Drug Products