Non-GMP Manufacturing

Our small molecule non-GMP manufacturing services support the journey of your early-stage molecules from concept to pre-clinical production, accelerating their path to clinical readiness. We produce non-GMP material in quantities from milligrams to 100s of grams for pre-clinical testing.

Below you can read more about:

Pre-clinical Material Manufacture

Our flexible pre-clinical material manufacture services deliver high-quality material tailored for early-stage testing. Using innovative down-stream recovery methods, we support your candidate from proof of concept to pre-clinical studies.

Our services include:

  • Manufacture of up to multi-100 gram quantities of non-GMP material suitable for pre-clinical studies.
  • Diverse purification techniques including chromatographic, re-crystallisation, solvent extraction, distillation, reactive extraction and others.
  • Tailored storage conditions to assess the stability and shelf life of pre-clinical material.
  • Detailed documentation, including batch records and analytical data, to ensure traceability and support seamless transition to GMP production.
Fermentation scientist using equipment

Quality Assurance

Production of material to be used in pivotal studies is supported by a dedicated program management and quality assurance team. All R&D activities are performed within a defined QMS including electronic lab books, SOPs, training records, and equipment maintenance with full QA oversight. This includes:

  • Independent QA review of project documents (Qualification Reports, Development Plans / Reports, Master and Batch Manufacturing Records, Quality / Process Risk Assessments).
  • Equipment qualification, maintenance and calibration to ensure performance meets expectations.
  • Tracked incoming goods procedures to ensure source and quality of raw materials or consumables meet specifications for analytical, USP, and DSP processes.
  • Independent consultants to advise on best practice for regulatory compliance during manufacturing.
  • Production of critical material to Batch Manufacturing Records by trained personnel from a range of backgrounds, including GMP manufacturing.
  • Dedicated suites for Microbial and Mammalian production activities.
  • Regular reviews of process and project performance, including Management Reviews, and Internal Audits.
  • Data integrity assurance throughout the project lifecycle.

The Ingenza QMS is designed in line with ICH Q10, and supports the requirements of ICH Q7.

Scientist using computer in office