Product/Service

cGMP Synthesis and Contract Manufacturing Services

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The SCYNEXIS process chemistry team offers fully-integrated contract research and development solutions including chemical development, non-GMP and GMP API synthesis, along with regulatory and CMC section support. 

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Brochure: Process Chemistry And cGMP API Manufacturing
Brochure: SCYNEXIS Overview
SCYNEXIS Capabilities Overview


The selection of a Process Chemistry outsourcing partner is one of the most critical decisions in your drug development program. At SCYNEXIS, you gain the skill level, experience and infrastructure of a big company with the responsiveness and agility of a focused chemical development team. More than half of our team hold Ph.D.’s and we are above all else, expert problem solvers.

SCYNEXIS Process Chemistry: Customer-focused Process Research
Chemical process development is as much art as it is science and at SCYNEXIS our artistry begins with our creative chemists. At SCYNEXIS, you will find our chemical expertise is second to none. The process chemistry team provides practical solutions for complex chemical problems based upon extensive industry experience. Our average chemical development scientist has worked in the pharmaceutical or CRO business for more than 15 years. More than half of the SCYNEXIS chemical development team members hold Ph.D. degrees and our facilities are best-in-class and registered with both the FDA and DEA.

Our project managers will ensure their teams meet the most demanding timelines using the flexibility of multiple resourcing models including: Time & Materials, Fixed Bid Contracts and Full-Time Equivalent (FTE) programs with dedicated resources. Our team has outstanding analytical support including in-house NMRs (GMP-compliant), multiple LC-MS systems, GC-MS, and more than 30 HPLC systems. The team consists of dedicated experts to assist in all method development, validation and impurity identification activities to accelerate your chemical development programs.

SCYNEXIS Process Chemistry & cGMP API Manufacturing: Selected Achievements

  • Reduced cost of goods (COGS) by more than 88% for a client that originally placed the initial phase of the project with a competitor, saving the client more than $72,000 per kilogram of API
  • Performed full technical transfer of a Phase 3 nucleoside campaign in six weeks from client contact to batch release
  • Rapidly scaled-up a lab-scale process from milligrams to multi-kilograms of GMP material while removing costly chromatography and lyophilization
  • Reduced 16-step synthesis to six steps with an innovative chemical development approach
  • Developed Intellectual Property (IP) for a client to produce enantiomerically pure compound by simple recrystallization

 

About SCYNEXIS:
SCYNEXIS is a premier drug discovery and development company offering fully-integrated contract research and manufacturing services including Medicinal Chemistry & Drug Discovery, In Vitro Pharmacology, ADMET-PK/Bioanalytical, Process Chemistry & cGMP API supply. SCYNEXIS is both FDA and DEA registered and headquartered in Research Triangle Park, NC – www.scynexis.com.