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CDMO Red Flags You Can’t Ignore: Regulatory Shortfalls and Misalignment
A CDMO can have the best scientists, excellent facilities, and strong technical execution, yet still fall short when it comes to regulatory alignment. This disconnect between scientific performance and regulatory readiness is one of the most damaging red flags in drug development as it could delay getting your molecule into the clinic.
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CDMO Red Flags You Can’t Ignore: Underestimating Technology Transfer Complexity
Transitioning a process from discovery scale to GMP manufacturing is almost never straightforward. What runs smoothly at 100 milligrams in the lab can behave very differently at the kilogram scale. Yet too many programs falter because the complexity of this transition is underestimated or treated as a simple “copy and paste” exercise.
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O.N.E Symeres: A Practical Approach to Real-World Drug Development
No drug development program runs perfectly. Chemistry misbehaves, funding shifts, and timelines tighten. But what defines a reliable partner is how they respond. O.N.E Symeres is the framework we use to keep projects moving through uncertainty: openness, nimbleness, and expertise.
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CDMO Red Flags You Can’t Ignore: Undefined or Shifting Project Scope
Selecting the right CDMO is one of the most important decisions in drug development. Yet even experienced biotechs and pharma companies can find themselves trapped in projects where the initial excitement gives way to frustration, and one of the most common culprits is a poorly defined scope.
Latest patents
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Novel intermediate in production of oxoisoquinoline derivative with BTK inhibitory activity
Number: WO2024134859 (PCT/JP2022/047526)
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Compounds and their use as PDE4 activators
Number: WO/2024/038129
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Compounds and their use as PDE4 activators
Number: WO/2024/038128
Latest publications
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Silicon-based Linkers for Tunable Acid-Sensitive Drug Release from Polymeric Nanoparticles
Article: Chemistry Europe. 2024 Dec 11:e202403589
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Rare Case of Polymorphism in the Binary System of Enantiomers of a Praziquantel Derivative
Article: Org. Process Res. Dev. 2024, 28, 4, 1224–1232
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Towards Multitargeted Ligands as Pain Therapeutics: Dual Ligands of the Cavα2δ-1 Subunit of Voltage-Gated Calcium Channel and the μ-Opioid Receptor
Article: ChemMedChem 2024, e202300473
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