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| Redefining Prefillable Syringe Systems | A prefillable syringe platform streamlines early drug product development by providing an integrated, system-level approach to accelerate clinical fill. Built around a single verification package, compatibility assessments, aligned shipping formats, and system-level testing, it reduces development complexity and unnecessary testing. A structured documentation pathway guides teams from feasibility through regulatory submission, simplifying system selection, supporting consistent performance, and helping manufacturers bring safe, effective therapies to patients more efficiently. |
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| How Rheology Ensures Effective Quality Control | Article | TA Instruments | Rheology connects formulation science to manufacturing reality. By tracking how drugs flow and respond to stress, teams can prevent batch variability and protect dosage performance. |
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| Coordinated Development As An Execution Framework | White Paper | Thermo Fisher Scientific | See how integrating clinical, development, manufacturing, and supply functions within a single execution framework can transform program performance and accelerate development success. |
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By Mark F. Witcher, Ph.D. | Since every sponsor–CDMO relationship can have widely different scopes, requirements, and procedures, this article focuses on the basic principles for analyzing and managing the risks of not achieving the relationship’s objectives. | |
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INDUSTRY INSIGHTS CONTINUED |
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| De-Risking FIH: Integrated Strategies For Rapid Proof-Of-Concept | Article | By Andreas Reichl, M.D., and Kevin Schaab, Ph.D., Quotient Sciences | Proper planning for first-in-human studies is crucial to successful drug development, which requires innovative trial designs and sound CMC strategies to mitigate risk and expedite proof-of-concept. |
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| The Benefits Of Transparent Pricing | Article | AbbVie | Streamline biopharma budgeting and expose hidden contract manufacturing fees. An all-inclusive pricing model ensures predictable partnerships from initial scale-up to commercial approval. |
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| Managing Endotoxins - Detect, Prevent, Remove | Webinar | MilliporeSigma | Explore the risks of endotoxin contamination in drug manufacturing and discover sustainable, animal-free detection methods to ensure pharmaceutical safety and regulatory compliance. |
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| Glove Integrity Testing: Changes In EU GMP Annex 1 | Article | TEMA SINERGIE | EU GMP Annex 1 now defines clear expectations for glove integrity testing. Examine how reliability, efficiency, and equipment usability are becoming essential factors for maintaining compliance. |
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| Local Delivery For Treatment Of Lung Cancer | Webinar | Lonza | Review two case studies where lung cancer therapies were delivered to the lung by dry powder inhaler in a rat model and evaluated for efficacy, confirming local delivery as a promising route. |
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| How To Reduce Waste And Improve Line Efficiency | Webinar | Thermo Scientific Product Inspection | False rejects signal correctable issues, not unavoidable outcomes. Learn how system setup, environment, and operational factors influence performance and how adjustments can improve yield. |
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| Reducing Wastewater Incineration And Carbon Emissions | Article | By Dr. Niklaus Künzle and Dr. Andreas Sieber, Lonza | To reduce CO2 emissions and recycle higher volumes of solvent, manufacturers must engineer approaches with flexible technologies that can be adapted to accommodate different products. |
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| AAPS PharmSci 360 | AAPS PharmSci 360 delivers research from across the drug development pipeline. Thousands of scientists from across the globe will converge October 25-28 in New Orleans to discuss cutting-edge breakthroughs at this science-first event. |
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