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CDMO red flags you can’t ignore: Capacity constraints and resource stretch

Part 4: When “Too Busy” Becomes a Business Risk Even the most capable CDMO cannot deliver high-quality work if it is stretched too thin. As demand for outsourcing continues to rise across the life sciences sector, many CDMOs are operating near or beyond capacity. For pharma and biotech companies, this creates a silent but serious […]

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08.12.25

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 […]

25.11.25

CDMO red flags you can’t ignore: Underestimating technology transfer complexity

Part 2: Why “Scale-Up” Isn’t Just a Bigger Batch 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 […]

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.

14.11.25

CDMO red flags you can’t ignore: Undefined or shifting project scope

Part 1: Is an Undefined Scope Putting Your Project at Risk? 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 […]

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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