Process Development Focused
Solving Chemical Development Problems

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 team. Our Process Chemistry Team is balanced with expert analytical R&D support. On average, each member has more than seventeen years of industry experience. We are capable of handling a wide variety of custom chemistries and scale-up projects including synthesizing reference standards, impurities, metabolites, degradation products, intermediates, GLP toxicology batches, controlled substances, orphan drugs and GMP API Manufacturing. Our Process Chemistry Team leadership consists of tenured veterans from companies including Merck, GSK, Eli Lilly, DSM, BASF, Sanofi-Aventis and Pfizer.

cGMP API Manufacturing

SCYNEXIS’ cGMP manufacturing department has conducted a broad range of programs from Phase 1 material supplies to supporting a NDA submission in our three modern, well-equipped cGMP kilo-scale manufacturing suites. This controlled-access suite has a dedicated air handling system with independent inerting lines for each manufacturing lab. We can accommodate a wide range of chemical processes by utilizing equipment such as six-inch preparative chromatography systems, stainless steel pressure reactors and vessels up to 200L (glass-lined stainless steel & glass fixed reactors) that are controlled by programmable chillers/heaters with full temperature range capability (-80ºC/+200ºC).

Success with SCYNEXIS

Our team is comprised of an equal balance between process and analytical chemists who work side-by-side to develop safe, scalable, efficient and cost-effective chemical processes. Our broad base of chemical development expertise includes:

As of 2011, SCYNEXIS has generated more than 10 process patents for clients and enabled more than 25 IND filings. We have worked with more than 65 global clients including virtual development organizations, mid-size pharma, biotechs and Top 25 pharma companies on over 600 projects in a variety of arrangements including fixed-fee, time & materials and FTE’s. In October of 2009, SCYNEXIS was inspected by FDA as part of both a general and pre-approval inspection (PAI). SCYNEXIS passed the inspections with no 483 observations.