Beginning July 31, 2026, a U.S. pharmaceutical tariff will apply to patented products and their APIs, beginning with large companies. Beroe Inc.'s Mathini Ilancheran breaks down the tariff's impact, explores its risks, and proposes five procurement strategies to addressing them.
- From Principles To Practice: Building Quality Into Generative AI-Assisted Pharma Operations
- New Research: Co-Expression Could Make Plant-Based Systems Viable
- Quantifying Single-Use Waste Produced During mAb Manufacture
- From QM To QMM For AI-Assisted Pharmaceutical Manufacturing Operations
- Immobilized Enzymes Promise Alternative To Cyanogen Bromide's Toxicity
- Ever Wonder What Running A $50B Capital Facilities Project Feels Like?
- Generative AI Can Write The Code, But Who Builds In The Quality?
GUEST COLUMNISTS
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From Principles To Practice: Building Quality Into Generative AI-Assisted Pharma Operations
Learn what regulators are already asking about AI, what quality must mean in this new context, and how organizations can begin building the governance infrastructure.
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New Research: Co-Expression Could Make Plant-Based Systems Viable
By co-expressing Protein A with the protein of interest, the work proposes to reduce the abundant cost of chromatography resins with a one-pot purification approach.
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Quantifying Single-Use Waste Produced During mAb Manufacture
Discover the current scale of plastic single-use technology waste and its projected growth, specifically for the biomanufacturing domain. There is an increasing need for sustainable solutions.
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From QM To QMM For AI-Assisted Pharmaceutical Manufacturing Operations
The FDA’s focus has shifted from tracking quality metrics to promoting quality management maturity. AI/ML is poised to help with efforts, though it introduces additional complexity around data integrity.
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Immobilized Enzymes Promise Alternative To Cyanogen Bromide's Toxicity
Proteases may be more expensive up front, but the benefits of cutting out a highly toxic substance quickly add up when disposal and environmental safety costs go down.
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Ever Wonder What Running A $50B Capital Facilities Project Feels Like?
Eli Lilly and Company's projects in the U.S. include greenfield sites where little infrastructure exists. Here's how the company's approaching the challenge.
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Generative AI Can Write The Code, But Who Builds In The Quality?
Code democratization demands a return to the fundamentals of quality in pharmaceutical and regulated environments.
BIOSIMILAR WHITE PAPERS
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Innovation In Filtration
Filtration removes contaminants to ensure safety and is essential in various applications, from lab-scale tasks to GMP production. Explore how its simplicity and reliability make it indispensable.
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Why Choose Robotic Processing For Small Batch Aseptic Filling1/9/2026
Reducing human intervention in aseptic filling is critical for safety and cost efficiency. Learn why automation is essential for small-batch applications and how it’s transforming sterile drug manufacturing.
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Perfusion Cell Line Development For Intensified Processes5/5/2025
The biopharmaceutical industry is transforming by shifting to continuous and intensified upstream bioprocesses, which are driven by evolving demands. Discover the key goals and innovations shaping this transition for modern healthcare.
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2024 Global Biopharma Sustainability Review9/3/2024
What steps is the biopharma industry taking to enhance sustainability? What challenges does biopharma encounter? And how can the entire industry draw lessons from the companies setting the standard?
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Aseptic Process Design And Simulation Under Annex 1 Guidelines1/9/2026
Gain insight into how Annex 1 reshapes aseptic process validation, as well as into risk reduction by design and why isolators are redefining modern sterile manufacturing standards.
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Ready To Demystify Organoids?7/1/2025
Organoids are transforming biomedical research. Explore their top applications, research workflows, key challenges, and dissociation techniques in this comprehensive guide to personalized medicine.
BIOSIMILAR APP NOTES & CASE STUDIES
- Application Of A Dual Spiking Strategy In Viral Clearance Studies
- Balancing Protein A Resin Cost, Performance, And Productivity
- Optimization And Scale-Up Of A Plasmid DNA Production Process
- Adapting Single-Use Chromatography To Manufacturing Scale
- Optimizing TFF And SPTFF For High-Concentration mAb Formulations
BIOSIMILAR DEVELOPMENT CONTENT COLLECTIONS
The debate over whether the biosimilar regulatory paradigm can shift away from comparative efficacy trials has intensified over the past few years. This collection of articles serves as a snapshot of the many different components of this ongoing discussion.
More Content CollectionsBIOSIMILAR DEVELOPMENT NEWS
- Mabwell Establishes A Licensing And Commercialization Agreement For Denosumab Biosimilars In Malaysian Market
- Twenty Years Of Biosimilar Medicines: A Milestone That Continues To Transform Patient Access Worldwide
- Henlius Announces First Patient Dosed In Clinical Trial Of HLX319, China's First Subcutaneous Fixed-Dose Injection Of A Pertuzumab/Trastuzumab Biosimilar
- The rituximab With The Most Approved Indications Domestically, Henlius' HANLIKANG Has Obtained Approvals For Two Additional Indications
- CMS Grants Fresenius Kabi COVID-19 Indication-Specific HCPCS Codes For Tyenne (tocilizumab-aazg)
- Aurobindo arm CuraTeQ Reports Positive Phase 3 Results For Allergy Drug BP11
- Apotex Strengthens Osteoporosis Care In Canada With Health Canada's Approval Of DENOZA™, A Denosumab Biosimilar
- Biocon Announces U.S. Commercial Launch Of Bosaya And Aukelso, Denosumab Biosimilars
NEWSLETTER ARCHIVE
- 04.16.26 -- Innovation That's Redefining Aseptic Filling
- 04.16.26 -- How Biopharma Continues To Grapple With Annex 1
- 04.09.26 -- Trends In FDA 2025 Warning Letters
- 04.02.26 -- The Hidden Engineering Behind Successful Upstream Bioprocessing
- 03.26.26 -- A simple, helpful look at PUPSIT implementation.