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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Manual vs. Automated Labware Washing
Compare manually washed labware and labware cleaned in automatic washing systems, to see how the challenges of manual washing can impact your labs efficacy and repeatability.
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Solving Cost And Supply Challenges In Biopharma Downstream Processing7/20/2023
In response to the growing demand for monoclonal antibodies, researchers are looking at different areas of the downstream process where they can improve efficiency and scalability.
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Five Biggest Considerations When Choosing A Buffer Management Solution10/12/2022
Learn the five most significant considerations when choosing a buffer management solution that will aid manufacturers trying to decide which is suitable for their unique circumstances.
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The Business Case For Pharmaceutical Continuous Manufacturing6/2/2023
Examine a step-by-step approach outlining the business cases that support adopting continuous manufacturing, with considerations for innovators, generics manufacturers, CDMOs, and OTC suppliers.
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Revolutionizing Particle Characterization With Image Analysis And ML9/27/2023
The biopharmaceutical industry is increasingly employing micro-flow imaging for particle characterization, owing to the superior insights it can afford into product quality and process controls.
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Containment Solutions To Help Emerging Biologic Companies Get Products To The Market Faster3/24/2023
Gain solutions on how to set up your small company for long-term success using packaging containment offerings and services to help mitigate risks and speed up your time to market.
BIOPROCESSING APP NOTES & CASE STUDIES
- Carryover Analysis Through Two Consecutive Cell Culture Harvests
- Compatible Platforms For Microbial Identification
- COVID-19 Impact To Biological Drug Products Safety
- Molecular Weight Confirmation For Length, Integrity And Impurity Analysis Of A 70-Mer Oligonucleotide
- Achieve Fast And Efficient Isolation Of Exosomes From Stem Cells
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