(Clinical) Production

Commercial production under GMP

Aseptic cGMP production

Reliability

  • Robust protocol development

GMP-compliant design

  • Inert fluidic path suitable for CIP (clean in place)
  • Validated cleaning procedure

Logging capabilities

  • Automatic batch record generation and operations logging  (In compliance with FDA: 21 CFR Part 11)
  • Maintenance management
  • Live process visualization

Closed system production capabilities

Good manufacturing practice

  • Sterility

    Sterile manufacturing is a requirement for many pharmaceutical products. To enable clinical production of microspheres with microfluidics Emultech has created a technology platform suitable for aseptic manufacturing.

  • Fill & finish

    Emultech is partnering with a range of CDMOs incorporating our cGMP system to provide fill & finish capabilities for clinical production of your parenteral and other drug products.

  • Throughput

    Emultech is the first and only company in the world to create a technology platform on the basis of microfluidics that can produce from a single chip several kilograms of microspheres on a weekly basis. Further parallelization can increase the throughput to meet your specific requirements.

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