First-in-human (FIH) studies represent a critical milestone in drug development—the point at which a new compound moves from the laboratory into living patients for the very first time. In the UK, these early-phase trials are growing in number, with MHRA data showing a 5% rise in FIH trial applications during 2025 compared with the previous year. Yet success at this stage often depends not on the molecule itself, but on the reliability and compliance of the supply chain behind it.
For sponsors running FIH studies, one of the most common operational headaches is sourcing small quantities of investigational medicinal product (IMP) to the exacting standards required by current Good Manufacturing Practice (cGMP). Most large-scale contract development and manufacturing organisations (CDMOs) are built for volume. When a biotech or academic group needs 50 units rather than 50,000, it can be difficult to find a manufacturing partner willing and equipped to produce at that scale without compromising quality or timeline.
What Makes FIH Supply Different
First-in-human trials operate under heightened regulatory scrutiny. The MHRA applies a risk-proportionate approach, but FIH protocols typically require the most rigorous safety oversight because the compound has never been administered to people before. The IMP must be manufactured in a facility that holds the appropriate cGMP certification, with full documentation to support the Investigational Medicinal Product Dossier (IMPD) submission.
Unlike later-phase studies where manufacturing processes are well established, FIH production often involves formulation development, stability testing with limited data, and the need to produce very small quantities—sometimes as few as a dozen doses. This demands a manufacturer with genuine flexibility: one that can hand-make batches, adapt quickly to protocol changes, and provide Qualified Person (QP) release without months of lead time.
The Challenge with Large CDMOs
Many CDMOs operate on a minimum batch model that simply does not accommodate early-phase needs. When a small biotech approaches a large CDMO for 100 capsules, it often faces minimum order quantities designed for Phase III or commercial production, lead times of six months or more due to scheduling around larger clients, and pricing structures that make small runs prohibitively expensive. The result is that sponsors either overproduce and waste product, accept delays that push back their regulatory timelines, or attempt to manufacture in-house without adequate facilities.
How IPS Pharma Supports Small-Batch IMP Production
IPS Pharma operates a cGMP-certified manufacturing facility specifically equipped for small-batch and one-off production of unlicensed medicines and investigational products. This means sponsors can commission bespoke IMP manufacturing at precisely the scale their protocol requires, without paying for capacity they do not need.
The facility supports hand-made batches for oral solid dosage forms, including capsule filling, tablet handling, and powder-in-bottle preparations. Critically, IPS Pharma provides integrated QP services, so the same organisation that manufactures the product can also certify it for use in the clinical trial—eliminating the delays and coordination issues that arise when QP release sits with a separate contractor.
For full details of IPS Pharma’s manufacturing capabilities, visit Clinical Trial Supplies.
Additional information on unlicensed medicine manufacturing is available at Unlicensed Medicines (Specials).
Regulatory Context: The 2026 UK Clinical Trial Regulations
The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 come into force on 28 April 2026, representing the most significant overhaul of UK clinical trial legislation in over two decades. Of particular relevance to FIH sponsors, the updated framework introduces a 14-day assessment route for Phase 1 trials, enabling faster regulatory decisions on the earliest-stage studies. Around one in five trials are expected to qualify for a new fast-track notification route, reducing start-up timelines for lower-risk studies.
These reforms mean that the regulatory side of FIH study initiation is getting faster—but this only delivers value if the supply chain can keep pace. A manufacturing partner that can produce IMP within weeks rather than months becomes a genuine competitive advantage for sponsors looking to capitalise on the UK’s reformed regulatory environment.
Benefits and Considerations for UK Sponsors
Benefits
- Reduced waste and cost through right-sized manufacturing
- Faster turnaround from formulation to QP-released product
- Integrated services (manufacturing, labelling, QP release) reduce coordination risk
- UK-based facility avoids import complexities and customs delays
Considerations
- Sponsors should confirm cGMP certification and MHRA inspection history of any manufacturing partner
- FIH protocols may require rapid formulation changes—ensure the CDMO can accommodate iterative development
- Stability data requirements should be discussed early in the engagement
Steps to Engage a Small-Batch IMP Manufacturer
- Define your protocol requirements: dosage form, quantity, labelling, and blinding needs.
- Verify the manufacturer holdsappropriate cGMPcertification and a current MHRA Manufacturer’s Specials Licence or equivalent.
- Request a feasibility assessment including estimated timelines and costs.
- Confirm that QP release services are available in-house or through an established arrangement.
- Ensure your IMPD can be supported with the manufacturer’s documentation.
You can contact IPS Pharma directly at ips-pharma.com/contact to discuss your project requirements.
Safety and Quality Considerations
Every IMP batch must be manufactured and released in accordance with the principles of cGMP, as regulated by the MHRA. The Qualified Person is legally responsible for confirming that each batch meets the specification before it is released for use in the trial. For FIH studies, this is especially critical—there is no prior human safety data, so the quality and consistency of the product must be beyond question.
Sponsors should also ensure their supply chain partner can demonstrate robust quality management systems, including deviation handling, out-of-specification investigation procedures, and documented change control processes.
How to Verify Manufacturer Legitimacy
- Check the MHRA public register for the manufacturer’s licence status
- Request copies of the most recent MHRA inspection report or certificate
- Confirm that QPs are registered and in good standing with the relevant professional body
- Review the manufacturer’s track record with similar small-batch projects
External Resources
MHRA – Clinical Trials Hub: Apply for approval in the UK
Health Research Authority – Clinical Trials Regulations Reform
NIHR – Be Part of Research
EMA – Good Manufacturing Practice guidance
References
- IPS Pharma. Clinical Trial Supplies. Available at: https://ips-pharma.com/clinical-trial-supplies/ [Accessed March 2026].
- MHRA. Patients to benefit sooner as UK boosts clinical trials attractiveness. GOV.UK, 13 January 2026.
- Health Research Authority. Clinical trials regulations reform. Available at: https://www.hra.nhs.uk/ [Accessed March 2026].
- MHRA Inspectorate Blog. Clinical trials regulations: six-month countdown begins. 28 October 2025.
- ManfrinA. et al. (2025) Evaluation of the MHRA’s introduction of a risk-proportionate approach for clinical trials. British Journal of Clinical Pharmacology. DOI: 10.1002/bcp.70308.
