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Process Enabling Technologies
Five platforms that change what a route can do, available from the first scouting experiment through to commercial supply.
The same platforms, at every stage of the program
Routes are fixed early. If flow chemistry or an enzymatic step is the right answer for a step, that is best established while the route is still being chosen, because changing it after the process is locked means a comparability exercise.
The five platforms below are available at every stage of a program. The chemists who run them at commercial scale are available while the route is still on paper.
Steps manufactured on each platform
703 steps have been manufactured by flow chemistry, 349 by chemocatalysis and 130 by biocatalysis, 98 compounds have been purified by preparative chromatography at manufacturing scale, and crystallization and particle engineering apply across the whole API portfolio.
Flow chemistry
703 steps manufactured. Flow is used where batch is unsafe, unselective or impossible — highly exothermic chemistry, unstable intermediates, reactions that need precise residence time. It also changes the scale-up question, because a flow process is scaled by extending the run time.
Chemocatalysis
349 steps manufactured — the second most used platform we have. Catalytic steps that replace stoichiometric reagents cut waste, cost and often step count, and they are usually the largest single improvement available when a route is optimized for commercial manufacture.
Biocatalysis
130 steps manufactured. Enzymatic steps deliver selectivity that chemistry struggles with, particularly chiral centers that would otherwise need a resolution and lose half the material.
Crystallization and particle engineering
Applied across 100% of API steps. Crystallization determines polymorph, purity and particle size, which in turn determine how the drug substance behaves in formulation. It is the step where drug substance and drug product meet.
Preparative HPLC, SFC, and SMB
98 compounds manufactured. Chromatographic purification at manufacturing scale, for molecules where crystallization will not deliver the purity or the separation. Supercritical fluid chromatography and simulated moving bed both run alongside conventional preparative HPLC.
All five platforms run inside containment
Every platform above is available for high-potency compounds at an occupational exposure limit of 10 ng/m³.
Measured in steps manufactured
A platform that has been through many campaigns and an inspection behaves differently from one that has been run once. The measure is the number of steps manufactured: