Non-GMP Manufacturing

Our biologics non-GMP manufacturing services support the journey of your early-stage lead candidate through all stages of pre-clinical production and testing, accelerating their path to clinical trials. We produce non-GMP material in quantities from milligrams to low grams for early-stage proof-of-concept studies confirming efficacy, through to IND enabling GLP compliant toxicology safety evaluation. Material can be produced in either mammalian or microbial expression hosts.

You can read more about our expertise and success stories below.

Pre-clinical Material Manufacture

Our flexible pre-clinical material manufacture services deliver material tailored for early-stage testing needs, ranging from R&D material for early efficacy testing, to higher quality material for IND enabling toxicology studies.

Our services include:

  • Manufacture of milligram to multi gram quantities of non-GMP grade material suitable for a range of pre-clinical studies.
  • Diverse purification techniques, including filtration and chromatography, to achieve target specifications and ensure high-purity material.
  • Freeze-drying, cryopreservation, and tailored storage conditions to maintain the stability and shelf life of pre-clinical material.
  • Comprehensive analytical support, including purity, identity, and concentration measurements.
  • IPC/IPM identification and monitoring.
  • Detailed documentation, including batch manufacturing 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