Other Services We Provide

At NCE Development, LLC, we understand that many of your drug development activities are not required to be conducted in a cGMP fashion.  This freedom from regulatory requirements reduces your costs and shortens the timeline for completion for non-cGMP projects.

Services include:

1. Process optimization

To save on unnecessary expenses, a drug manufacturing process should only be optimized at key points along the developmental timeline in a manner that is commensurate with its intended use.  For example, the process used to manufacture the tox batch must provide material that is representative of what will be used in the first time in humans clinical trial (Phase 0, or Phase I), however, it does not need to be prepared in compliance with cGMP regulations.  For this reason, only the amount of process development work necessary to ensure a reproducible quality profile should be invested at this point.  For Phase II, additional optimization work will need to be performed to identify and control critical process parameters. 

In Phase III, the design space will need to be defined to support process validation efforts.

a.Route selection / atom economics
b.Cost reduction (materials and labor)
c.Improved throughput (space-time yield)
d.Critical process parameter screening
e.Design space definition
f.Waste reduction

2. Fate and Purge Studies (spiking studies)

As the developmental cycle continues, your processes should be challenged by deliberately spiking known concentrations of impurities to determine how well they are purged from the system.  Additionally, impurities will often undergo a chemical transformation themselves, and should be tracked by determining their fate during the reaction.  The newly formed impurities should then be independently tested to see how effectively they are purged by the downstream processing steps.

3. Reference standard synthesis and qualification

Fully qualified reference standards must be produced in quantities sufficient to support analytical and process developmental studies as your drug progresses towards IND and NDA filing milestones.  These may include the following:

a.Active pharmaceutical ingredient
b.Starting material impurities
c.Starting materials
d.Intermediates
e.Process impurities
f.Potential or hypothetical impurities
g.Metabolites or hypothetical metabolites