With industry-leading expertise and a highly experienced pool
of scientists, Porton has helped clients develop more than 1,200 Active
Pharmaceutical Ingredients (API) and advanced intermediates, among which more
than 200 New Chemical Entities (NCEs) have been approved in global markets. Operating with rigorous
precision and speed, we take a “Fit for
Purpose”, phase-appropriate approach to drug development.
Route Design and
Scouting
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Design and explore a new route of synthesis
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Develop a route of synthesis with a benchmark of 2~3 steps/week for route scouting. Our process chemists have ready access to LC-MS, GC-MS and NMR
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Quickly develop and optimize key steps using parallel reactors and high throughput screening platforms
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Evaluate new technologies for quick feasibility impact studies of recalcitrant chemical steps
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Safely handle and scale hazardous reactions
Process Development and Optimization
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Develop a Fit-for-Purpose process development and control strategy
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Perform process
development and synthesis of API to support GLP TOX and clinical studies
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Develop final
process suitable for commercial production and supply
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Optimize process to improve robustness and output
while reducing cost
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Screen and optimize
any high-cost catalysts using high throughput
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Perform salt
screening, polymorph screening, polymorph characterization, salt selection and
process development
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Develop API recrystallization process and optimize crystallization process
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Conduct impurity profile analysis, impurity
characterization, synthesis and specifications setting
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Apply Process Analysis Technology (PAT) to support
process development, e.g. online IR, online HPLC and FBRM
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Apply Quality by Design (QbD) principles for process
development, e.g. to utilize Statistical Design of Experiments (DOE) to study
the Design Space
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Handle high potency compounds with OEL<0.1ug/ m³
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Process safety test
and evaluation with RC1, DSC, TGA, ARC, TSU, etc.
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Support process
development with chemical engineering simulation (e.g. filtration rate
simulation, O2 content control evaluation) and project transfer equipment risk
evaluation (e.g. selection of reactor and agitator, rectification parameters
and azeotropy efficiency simulation)