Pharmaceutical Technology articleshttps://www.pharmtech.com/newsPharmaceutical Technology articles© 2026 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.Wed, 07 Oct 2026 19:19:50 +00005en-us14447https://www.pharmtech.com/newshttps://www.pharmtech.com/logo.webphttps://www.pharmtech.com/view/thermo-fisher-scientific-exhibits-new-solutions-and-expanded-capabilities-at-cphi-milanhttps://www.pharmtech.com/view/thermo-fisher-scientific-exhibits-new-solutions-and-expanded-capabilities-at-cphi-milan<![CDATA[The company is showcasing new development solutions and advanced digital technologies including its new OSD Express and Steriles Express solutions for drug development.]]>Wed, 07 Oct 2026 14:31:00 GMTPharmaceutical TechnologyusPharmaceutical Technology Articleshttps://www.pharmtech.com/view/packaging-and-delivery-decisions-must-reflect-real-world-carehttps://www.pharmtech.com/view/packaging-and-delivery-decisions-must-reflect-real-world-care<![CDATA[Ron Scarboro, Azurity Pharmaceuticals, explains when formulation robustness justifies added cost and which post-approval quality and supply metrics teams can track.]]>Wed, 07 Oct 2026 11:50:00 GMTPharmaceutical TechnologyusPharmaceutical Technology Articleshttps://www.pharmtech.com/view/winners-of-the-2026-cphi-pharma-awards-announcedhttps://www.pharmtech.com/view/winners-of-the-2026-cphi-pharma-awards-announced<![CDATA[The winners of the CPHI Pharma Awards 2026 include a neurodegeneration platform, a track-and-trace packaging innovation, a enzymatic mRNA manufacturing technology, and a cell-free enzymatic biomanufacturing platform.]]>Tue, 06 Oct 2026 19:03:00 GMTPharmaceutical TechnologyusPharmaceutical Technology Articleshttps://www.pharmtech.com/view/manufacturing-intelligence-organoids-organ-on-a-chip-and-the-trust-gaphttps://www.pharmtech.com/view/manufacturing-intelligence-organoids-organ-on-a-chip-and-the-trust-gap<![CDATA[Richard Jaenisch explains why NAMs are compressing drug development faster than AI and what FDA's new nonclinical testing rule means for sponsors.]]>Tue, 06 Oct 2026 15:27:31 GMTPharmaceutical TechnologyusPharmaceutical Technology Articleshttps://www.pharmtech.com/view/pharmtech-ai-pulse-check-on-prem-vs-cloud-aihttps://www.pharmtech.com/view/pharmtech-ai-pulse-check-on-prem-vs-cloud-ai<![CDATA[Shadow AI and vendor data retention put GMP records and trade secrets at risk. AI Pulse Check panelists outline what pharma AI policies require.]]>Tue, 06 Oct 2026 13:00:00 GMTPharmaceutical TechnologyusPharmaceutical Technology Articleshttps://www.pharmtech.com/view/can-continuous-tableting-end-scale-up-for-complex-oral-drugs-https://www.pharmtech.com/view/can-continuous-tableting-end-scale-up-for-complex-oral-drugs-<![CDATA[Hovione's $35M CDC Flex line links spray drying to tablets, designed to eliminate scale-up under FDA Q13 guidance.]]>Mon, 05 Oct 2026 14:49:38 GMTPharmaceutical TechnologyusPharmaceutical Technology Articleshttps://www.pharmtech.com/view/pharmtech-weekly-roundup-october-2-2026https://www.pharmtech.com/view/pharmtech-weekly-roundup-october-2-2026<![CDATA[This week on PharmTech, Merck diversified its pipeline, USP emphasizes supply chain security, AI systems are examined, and speakers preview their presentations at CPHI Milan and AAPS PharmSci 360. ]]>Mon, 05 Oct 2026 13:13:03 GMTPharmaceutical TechnologyusPharmaceutical Technology Articleshttps://www.pharmtech.com/view/cphi-milan-2026-nitrosamine-risk-mitigation-part-1https://www.pharmtech.com/view/cphi-milan-2026-nitrosamine-risk-mitigation-part-1<![CDATA[Capsugel's Bram Baert and Sandrine Picco argue that chasing zero nitrite in pharmaceutical excipients is often impractical and costly. They recommend setting scientifically justified, risk-based limits and consistently staying below them.]]>Mon, 05 Oct 2026 12:47:24 GMTPharmaceutical TechnologyusPharmaceutical Technology Articleshttps://www.pharmtech.com/view/why-end-to-end-pathway-ownership-mattershttps://www.pharmtech.com/view/why-end-to-end-pathway-ownership-matters<![CDATA[Ron Scarboro, Azurity Pharmaceuticals, claims drug reformulation that removes patient barriers must preserve efficacy, urging early cross-functional team alignment.]]>Mon, 05 Oct 2026 11:45:00 GMTPharmaceutical TechnologyusPharmaceutical Technology Articleshttps://www.pharmtech.com/view/cracking-the-gut-wall-the-platform-behind-oral-peptide-and-small-molecule-deliveryhttps://www.pharmtech.com/view/cracking-the-gut-wall-the-platform-behind-oral-peptide-and-small-molecule-delivery<![CDATA[Webinar Date/Time: Fri, Oct 30, 2026 11:00 AM EDT]]>Mon, 05 Oct 2026 04:53:00 GMTPharmaceutical TechnologyusPharmaceutical Technology Articleshttps://www.pharmtech.com/view/pharmtech-ai-pulse-check-episode-2---shadow-ai-trade-secrets-the-api-racehttps://www.pharmtech.com/view/pharmtech-ai-pulse-check-episode-2---shadow-ai-trade-secrets-the-api-race<![CDATA[PharmTech AI Pulse Check episode 2 covers AI data governance, API-gated journals, watermarking limits, and why attribution beats detection in GxP.]]>Fri, 02 Oct 2026 17:48:30 GMTPharmaceutical TechnologyusPharmaceutical Technology Articleshttps://www.pharmtech.com/view/regulatory-roundup-september-2026https://www.pharmtech.com/view/regulatory-roundup-september-2026<![CDATA[The FDA opened an expedited IND pilot, tightened scrutiny of foreign trial data, and finalized a rule recognizing non-animal testing methods. In Europe, the EMA advanced pharmaceutical legislation reform, restricted 2 legacy products, and opened an injectable-iron safety review.]]>Fri, 02 Oct 2026 15:38:00 GMTPharmaceutical TechnologyusPharmaceutical Technology Articleshttps://www.pharmtech.com/view/abo2203s-7b-milestones-signal-rna-capacity-demandhttps://www.pharmtech.com/view/abo2203s-7b-milestones-signal-rna-capacity-demand<![CDATA[Novartis licenses Abogen's mRNA-encoded T-cell engager for autoimmune disease, raising scale-up questions for mRNA-lipid nanoparticle manufacturing.]]>Fri, 02 Oct 2026 14:27:39 GMTPharmaceutical TechnologyusPharmaceutical Technology Articleshttps://www.pharmtech.com/view/viperturb-seq-genome-wide-crispr-screens-at-single-cell-resolutionhttps://www.pharmtech.com/view/viperturb-seq-genome-wide-crispr-screens-at-single-cell-resolution<![CDATA[Webinar Date/Time: Wed, Oct 21, 2026 11:00 AM EDT]]>Fri, 02 Oct 2026 04:53:00 GMTPharmaceutical TechnologyusPharmaceutical Technology Articleshttps://www.pharmtech.com/view/drapeau-s-ai-deep-dive-the-control-lab-tested-for-flavorhttps://www.pharmtech.com/view/drapeau-s-ai-deep-dive-the-control-lab-tested-for-flavor<![CDATA[Pharma manufacturing spent 90 years learning that producing correct outputs isn't the same as catching your own errors. AI has only learned the first.]]>Thu, 01 Oct 2026 12:11:13 GMTPharmaceutical TechnologyusPharmaceutical Technology Articleshttps://www.pharmtech.com/view/medication-non-adherence-is-a-design-problemhttps://www.pharmtech.com/view/medication-non-adherence-is-a-design-problem<![CDATA[Ron Scarboro, Azurity Pharmaceuticals, explains why real-world usability belongs at product definition and how post-launch feedback should guide drug formulation.]]>Thu, 01 Oct 2026 11:30:00 GMTPharmaceutical TechnologyusPharmaceutical Technology Articleshttps://www.pharmtech.com/view/q-a-usp-ceo-urges-manufacturers-to-act-now-to-stop-drug-shortageshttps://www.pharmtech.com/view/q-a-usp-ceo-urges-manufacturers-to-act-now-to-stop-drug-shortages<![CDATA[Ronald Piervincenzi, USP, explains why drug supply resilience needs a system approach, from procurement benchmarks to regulatory capacity building.]]>Thu, 01 Oct 2026 11:30:00 GMTPharmaceutical TechnologyusPharmaceutical Technology Articleshttps://www.pharmtech.com/view/scale-sirn-a-manufacturing-via-ligationhttps://www.pharmtech.com/view/scale-sirn-a-manufacturing-via-ligation<![CDATA[As siRNA therapeutics expand into larger patient populations and commercial-scale indications, manufacturers face increasing pressure to deliver high-quality drug substance at greater scale, improve efficiency, and with improved sustainability. This case study highlights how Codexis and Bachem collaborated to advance RNA manufacturing through a modular, enzymatic approach that combines short-fragment synthesis with engineered ligases to overcome the limitations of traditional oligonucleotide manufacturing. Using vutrisiran as a model siRNA, the study demonstrates how optimized fragment and enzyme design via Codexis’s FragLinkSM can drive high ligation efficiencies, reduce purification burden, and enable scalable multi-kilogram GMP production. The result is a flexible manufacturing strategy that helps developers accelerate scale-up, improve manufacturing economics, and prepare for future commercial demand.]]>Thu, 01 Oct 2026 04:40:00 GMTPharmaceutical TechnologyusPharmaceutical Technology Articleshttps://www.pharmtech.com/view/evolution-of-ered-and-kred-enzymes-to-enable-a-biocatalytic-cascadehttps://www.pharmtech.com/view/evolution-of-ered-and-kred-enzymes-to-enable-a-biocatalytic-cascade<![CDATA[Enereductases (EREDs) and ketoreductases (KREDs) are highly selective enzymes that offer greener alternatives to more traditional asymmetric hydrogenation reactions. Enzyme cascades are a powerful way to enable more environmentally friendly and cost-effective synthetic processes for the manufacture of APIs. Here we report the discovery and development of an ERED/KRED biocatalytic cascade to enable efficient installation of the two stereocenters on a cyclohexyl ring for the synthesis of BMS-986278, a potent small-molecule LPA1 antagonist. A combination of protein engineering and process development optimized the cascade, resulting in orders of magnitude improvement over the original cascade proof-of-concept, and an over four-fold reduction in PMI over the first generation non-biocatalytic campaign for synthesis of the fragment. The synthesis of BMS-986278 was honored as a co-winner of the 2023 Peter J. Dunn award for Green Chemistry &amp; Engineering Impact in the Pharmaceutical Industry, in large part because of the sustainability improvements enabled by this enzymatic cascade.]]>Thu, 01 Oct 2026 04:37:00 GMTPharmaceutical TechnologyusPharmaceutical Technology Articleshttps://www.pharmtech.com/view/companies-launching-equipment-and-services-at-cphi-milan-2026https://www.pharmtech.com/view/companies-launching-equipment-and-services-at-cphi-milan-2026<![CDATA[Gene manufacturing platforms, patient-centric formulations, contract services, packaging innovations, and sterile filling lines are in the spotlight at CPHI Milan 2026.]]>Wed, 30 Sep 2026 14:14:00 GMTPharmaceutical TechnologyusPharmaceutical Technology Articleshttps://www.pharmtech.com/view/why-one-reliable-supplier-isn-t-enoughhttps://www.pharmtech.com/view/why-one-reliable-supplier-isn-t-enough<![CDATA[Ronald Piervincenzi, USP, explains why drug supply resilience needs a system approach, from procurement benchmarks to regulatory capacity building.]]>Wed, 30 Sep 2026 11:30:00 GMTPharmaceutical TechnologyusPharmaceutical Technology Articleshttps://www.pharmtech.com/view/putting-what-we-already-know-to-workhttps://www.pharmtech.com/view/putting-what-we-already-know-to-work<![CDATA[Progress depends not only on discovery, but on how effectively the industry captures, shares, and applies what it has already learned.]]>Tue, 29 Sep 2026 16:47:00 GMTPharmaceutical TechnologyusPharmaceutical Technology Articleshttps://www.pharmtech.com/view/pharmtech-ai-pulse-check-interpath-001-precision-ml-pharma-s-governance-gapshttps://www.pharmtech.com/view/pharmtech-ai-pulse-check-interpath-001-precision-ml-pharma-s-governance-gaps<![CDATA[Episode 1, Part 3 of PharmTech AI Pulse Check covers why INTerpath-001's AI isn't ChatGPT and names pharma manufacturing's biggest AI governance gaps.]]>Tue, 29 Sep 2026 11:06:48 GMTPharmaceutical TechnologyusPharmaceutical Technology Articleshttps://www.pharmtech.com/view/building-a-bsab-cmc-playbook-decision-frameworks-risks-and-readinesshttps://www.pharmtech.com/view/building-a-bsab-cmc-playbook-decision-frameworks-risks-and-readiness<![CDATA[Webinar Date/Time: Thu, Oct 29, 2026 11:00 AM EDT]]>Tue, 29 Sep 2026 04:53:00 GMTPharmaceutical TechnologyusPharmaceutical Technology Articleshttps://www.pharmtech.com/view/pharmtech-pharmtech-europetm-formulation-advances-ebook-september-2026https://www.pharmtech.com/view/pharmtech-pharmtech-europetm-formulation-advances-ebook-september-2026<![CDATA[From next-generation biologics to smarter capsule technology and cleaner supplier communication, this ebook brings together 4 insights at where formulation science is headed and what it takes to get complex therapies safely from lab to patient. Inside, readers will find a look into the stability challenges of emerging biologics such as antibody-drug conjugates and bispecifics, including real-world case studies on taming viscosity and solubility at high concentrations. The industry's accelerating shift from IV to subcutaneous delivery is discussed, unpacking the regulatory approvals, patient-outcome data, and market forces turning at-home biologic dosing into standard practice. On the drug-delivery-innovation side, a feature on a novel capsule-in-capsule platform shows how liquid and solid actives can be combined in a single dose to cut pill burden without sacrificing performance. Rounding this eBook out, an IPEC-Americas explainer shows how the Excipient Information Package can replace slow, inconsistent supplier questionnaires with a standardized format that speeds qualification from months to days.]]>Tue, 29 Sep 2026 04:37:00 GMTPharmaceutical TechnologyusPharmaceutical Technology Articleshttps://www.pharmtech.com/view/cphi-milan-2026-digital-supply-chainshttps://www.pharmtech.com/view/cphi-milan-2026-digital-supply-chains<![CDATA[Michael Levy, senior vice president, Digital &amp; Innovation, USP, explains the digital supply chain in a preview of his upcoming CPHI Milan panel presentation, The Next Phase of Pharma Supply Chains.]]>Mon, 28 Sep 2026 20:07:28 GMTPharmaceutical TechnologyusPharmaceutical Technology Articleshttps://www.pharmtech.com/view/tavapadon-sets-development-benchmark-for-parkinsonshttps://www.pharmtech.com/view/tavapadon-sets-development-benchmark-for-parkinsons<![CDATA[FDA approves tavapadon, first D1/D5 agonist, validating AbbVie's $8.7B Cerevel deal and an October five-strength oral tablet launch.]]>Mon, 28 Sep 2026 18:48:29 GMTPharmaceutical TechnologyusPharmaceutical Technology Articleshttps://www.pharmtech.com/view/manufacturing-intelligence-what-fda-s-nam-rule-means-for-cmc-teamshttps://www.pharmtech.com/view/manufacturing-intelligence-what-fda-s-nam-rule-means-for-cmc-teams<![CDATA[Richard Jaenisch weighs how FDA's new NAM rule could reshape preclinical testing and what CMC teams should do now, on Manufacturing Intelligence.]]>Mon, 28 Sep 2026 17:28:35 GMTPharmaceutical TechnologyusPharmaceutical Technology Articleshttps://www.pharmtech.com/view/aaps-pharmsci-360-cmc-strategies-part-3https://www.pharmtech.com/view/aaps-pharmsci-360-cmc-strategies-part-3<![CDATA[In a preview of their panel discussion at AAPS PharmSci 360 2026, Alfred Rumondor, PhD, AbbVie, and Swita Singh, PhD, Bristol Myers Squibb, discuss the implementation of risk-based approaches for CMC.]]>Mon, 28 Sep 2026 17:19:15 GMTPharmaceutical TechnologyusPharmaceutical Technology Articleshttps://www.pharmtech.com/view/kras-g12d-inhibitor-s-2-13b-deal-tests-cross-border-tech-transferhttps://www.pharmtech.com/view/kras-g12d-inhibitor-s-2-13b-deal-tests-cross-border-tech-transfer<![CDATA[Merck licenses SciBrunch's preclinical KRAS G12D inhibitor for $2.13B, raising tech transfer and scale-up questions for oral cancer drug development.]]>Mon, 28 Sep 2026 14:53:37 GMTPharmaceutical TechnologyusPharmaceutical Technology Articles