Process development

Process lock

NovAliX can transform synthetic concepts into developed processes that are rugged, practical, cost-effectively conforming to industrial constraints.

The production an API on a pilot plant scale transcends the laboratory-scale organic synthesis but starts from a lab-based understanding of the parameters of scale-up for which NovAliX has acquired necessary expertise. Engineering, operational issues, scale-up problems and safety concerns are professionally addressed.

Polymorph control is critical for pharmaceutical performance and is also a regulatory requirement. NovAliX employs solid-state NMR spectroscopy to fully characterize polymorphs including the amorphous state. An advantage of NMR is the ability to quantify without the need to prepare a standard curve.

NovAliX follows Quality by Design guidelines to ensure consistent quality over time, eliminate sources of variations and anticipate regulatory demands.

Projects are controlled through a team composed of staff from both organizations. NovAliX becomes a flexible extension of your organization.

Features and benefits

Full process development support is generally conducted by a team of at least 3 synthetic chemists plus additional analytical support.

Study Associated tool or methodology Included
Process optimization under Quality by Design approach CPP, PAR, NOR determination
Stream and characterization of impurities
Analytical method development & validation
Quantitation of solvents
Optional
Engineering & practical concerns Mixing, mass & thermal transfer, filterability
Rework procedure development
Condition development for telescoping, crystallization, filtration
Optional
Safety studies RC1 calorimeter Optional
Solid-state characterization (salt, hydrate, solvate, polymorphism, particle size distribution) X-ray diffraction spectrometer, solid-state NMR, microscope, TGA, DSC, DLS Optional
Solid-state characterization (salt, hydrate, solvate, polymorphism, particle size distribution) X-ray diffraction spectrometer, solid-state NMR, microscope, TGA, DSC, DLS Optional
Regulatory filing   Optional