Process Development & Small Scale Manufacturing2020-05-11T10:58:10+00:00

Process Development & Small Scale Manufacturing

At SK biotek, we have substantial experience in the development and manufacture of quality Regulatory Starting Materials, Advanced Intermediates and Active Pharmaceutical Ingredients. Our highly talented team of chemists and engineers have extensive experience in custom development of challenging products from clinical phase, validation and commercial launch through to large-scale manufacturing.

Through the application of laboratory, kilo laboratory and kilo plant scale technologies including glass reactors, hydrogenators, leaf filter, centrifuge, filter dryer, wet mill and jet mill we have the ability to develop, optimise and scale-up processes.

We can enhance the knowledge and control of customers’ processes using our Fourier Transform Infra-Red, Lasentec Focused Beam Reflectance Measurement, Raman PAT Raman Process Analytical Technology capabilities and modelling applications.

SK biotek offers cGMP kilo scale manufacturing capability in our kilo plant as a next step from our High Potency API development at kilo scale can be accommodated in our cGMP high containment facility.


Advanced Synthesis

Continuous Process

Material Science

Project Management

Our high containment facility is equipped for the manufacture of High Potency API synthesis. We offer the following Process Development services:

  • Evaluation of synthetic route
  • Process risk assessment and establishment of critical parameters
  • Process safety assessment
  • Development and completion of optimisation/design space studies
  • Crystallisation development and powder property characterisation
  • GMP seed generation
  • Pre-clinical API manufacture

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