Aptuit | Integrated CMC | Highly potent substance

Controlled and highly potent substances

As a long established supplier of Active Pharmaceutical Ingredients (APIs), we have a wide range of experience and expertise in developing, manufacturing and handling highly potent and cytotoxic compounds. Our teams of scientists have more than twenty-five years of experience in synthesizing HPAPIs and delivering consistent and reliable high potency and cytotoxic APIs.

Aptuit | Highly potent substances

Isolated containment facilities for both drug substance and drug product development and manufacturing:
  • Isolated Class 100,000 suites designed with the most advanced barrier technology, including sophisticated clean-in-place systems
  • Engineering controls for product containment in segregated suites with dedicated HEPA filtration systems (inbound and exhaust) and individual egress points
  • Preclinical and clinical trials supply – from 10g to 10’s of kg
  • Commercial scale manufacturing from grams to 100’s of kg
  • Handling of Merck Category 4 compounds
  • Potent solid dose formulation of batch sizes up to 10kg
  • Facilities FDA and MHRA inspected

Our automated and validated computer controls, along with layered safeguards, are designed to protect both employees and the environment. And our quality driven oversight systems also carefully and strictly monitor processing areas, high containment areas, airlocks, decontamination equipment, gloveboxes, isolators, equipment trains and flexible containment.