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CDMO red flags you can’t ignore: Regulatory shortfalls and misalignment
Part 3: Could Regulatory Misalignment Be Delaying Your Submission? 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 […]
Blog
17.11.25
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.
Blog
10.07.22
Crystalline and liquid crystalline 25-hydroxy-cholest-5-en-3-sulfate sodium and methods for preparing same
Organix, a Symeres company, developed scale up conditions of the synthesis of 25-hydroxy cholesterol 3-monosulfate (sodium salt) from cholesterol. After the protection of the hydroxy group (acetate) and double bond (debromination), the hydroxy group in position 25 was introduced using oxone and trifluoromethylethylketone. Then the 3-hydroxy group and double bond were deprotected, and the resulting […]
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