Process Development


Development and optimization of manufacturing methods. Leadership of technology transfers (TT), optimization
of manufacturing process, process automation. Process validation studies.

Scope of development services

  • Design and development of customized manufacturing procedures
  • Development of SOPs and specifically-tailored working instructions
  • Process qualifications and validations
  • Management of technology transfers – development of TT plans and TT execution 
  • Manufacturing process optimization and automation
  • Data analysis and trending systems setup

Design of cGMP manufacturing suites including validation activities

Lab employees in full personal protective equipment handling cell and gene therapy products.

Our Services

Cell and gene therapy researchers working in SCTbio’s GMP laboratory.
Lab technician working at a microplate reader in SCTbio’s cell and gene facility.
Lab employees in full personal protective equipment handling cell and gene therapy products.
Employee loading up a cardboard box of biologic samples at SCTbio’s contract manufacturing facility.
Employee loading up a cardboard box of biologic samples at SCTbio’s contract manufacturing facility.
Calculator and office equipment on some paper at SCTbio offices in Prague.