GMP clinical trial pharmacy services in London

For more than 25 years, our London clinical trial facility has provided specialist GMP pharmacy services for Phase I and early Phase II studies. Our experienced team supports the manufacture, preparation, packaging, storage, import and QP release of investigational medicinal products for early-phase clinical trials in the UK.

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Pharmacist preparing an investigational medicinal product at Nucleus Network’s London clinical trial facility

Specialist GMP pharmacy support for early-phase clinical trials

Located within Nucleus Network’s London clinical trial facility, our specialist pharmacy provides integrated support for complex Phase I and early Phase II studies.

Our pharmacy team works closely with investigators, clinical operations teams, sponsors and biotechnology and pharmaceutical companies to support investigational medicinal products throughout the study lifecycle. Capabilities include sterile and non-sterile manufacture, dispensing, labelling, packaging, controlled-temperature storage, import and Qualified Person release.

By integrating pharmacy services with our clinical trial operations, we can help sponsors simplify study delivery, reduce operational handovers and maintain close oversight of investigational products throughout an early-phase trial.

GMP pharmacy and IMP manufacturing services

Our London GMP pharmacy supports the manufacture, preparation, packaging, storage and release of investigational medicinal products for Phase I and early Phase II clinical trials.

Our services include:

  • manufacture of sterile IV solutions
  • manufacture of non-sterile oral dosage forms, including solutions, suspensions and capsules
  • refrigerated storage at 2–8°C
  • frozen storage at –20°C, –40°C and –80°C
  • Qualified Person (QP) release
  • import of investigational medicinal products
  • label design, printing and application
  • primary packaging
  • secondary packaging

Our GMP-compliant sterile manufacturing facilities support the preparation of investigational medicinal products (IMPs) for Phase I and early Phase II clinical trials. We have extensive experience manufacturing sterile IV solutions and preparing radiopharmaceutical products for complex early-phase studies.

Our facilities include:

  • EU GMP-compliant sterile manufacturing suites
  • Controlled environmental conditions with electronic monitoring
  • Negative-pressure Envair CDC-F glove isolators
  • Controlled air change and pressure management
  • Surface air sampling and environmental monitoring
  • Dedicated transfer hatches and interlocked cleanroom access
  • Synchronised production environments to support GMP documentation

We have extensive experience preparing sterile IV infusions and parenteral injections, with all sterile investigational medicinal products undergoing Qualified Person (QP) release prior to clinical use.

Our pharmacy supports the manufacture and preparation of non-sterile investigational medicinal products for a wide range of early-phase clinical trials.

Capabilities include:

  • dispensing individual doses from bulk supplies
  • manufacture of oral solutions and suspensions
  • capsule manufacture
  • investigational product packaging
  • Qualified Person (QP) release of all manufactured products

Manufacturing is supported by specialist weighing, compounding and quality control equipment designed for GMP-compliant pharmaceutical production.

Our pharmacy team has supported investigational medicinal products across a broad range of therapeutic areas, dosage forms and administration routes, including:

Immunological

  • allergens – keyhole limpet haemocyanin; Candida albicans; chitin
  • monoclonal antibodies

Respiratory

  • Long acting ß2 agonist – IV solution, and powder for inhalation
  • Muscarinic receptor antagonist – powder for inhalation
  • CRTh2 antagonist – oral suspension
  • FLAP inhibitor – oral aqueous and lipid solutions; lipid-filled capsules

Cardiac

  • Statin – oral tablet
  • AT1 receptor binder – oral solution

CNS

  • 5HT1A receptor antagonist – oral tablet
  • Cannabinoid receptor agonist – IV solution
  • Allosteric M1 receptor agonist – oral solution and tablet
  • ORL1 receptor antagonist – oral capsule
  • Muscarinic antagonist – IV solution
  • AChE inhibitor – over-encapsulated oral tablet
  • CB1 receptor antagonist – oral capsule and IV solution
  • Opioid receptor agonist (morphine, comparator) – IV solution

Miscellaneous

  • Metastin derivative – IV solution
  • Transient receptor potential vanilloid antagonist – oral tablet
  • NK1 receptor antagonist – oral tablet
  • Gastrin receptor antagonist – oral capsule
  • Insulin – capsule for use in new nasal insufflator

Excipients

  • Croscarmellose sodium (CCM)
  • Hydroxypropyl methylcellulose (HPMC/hypromellose)
  • Starch 1500 (pregelatinized corn starch)
  • Bitrex
  • Ethanol
  • NaOH
  • NaCl 0.9%
  • Dextrose 5%
  • Polysorbate
  • Cyclodextrin

Our dedicated radiopharmacy supports the manufacture, dispensing and quality control of radiolabelled investigational medicinal products for early-phase clinical trials.

The facility includes purpose-built GMP radiopharmacy suites, specialist QC instrumentation and experienced radiopharmacy personnel supporting both microdosing and therapeutic studies.

Our experience includes radiolabelled compounds using Carbon-14, Tritium, Technetium-99m, Chromium-51 and Iodine-131.

We have:

  • Purpose-built radiopharmacy suite, with Envair CDC-F Technetium isolator for manufacture and dispensing of sterile radiolabelled IMP.
  • Tri-Carb 3100TR liquid scintillation analyzer, for QC, safety monitoring and sample assay.
  • Specialist experience of 14C radiolabelled IMP, for both microdosing and therapeutic dosing:
    • novel diaminopyrimidine antibiotic
    • gastrin antagonist
    • endothelin receptor antagonist
    • dimethoxime antimicrobial prodrug
  • Experience of manufacturing and dispensing IMP radiolabelled with radionuclide 3H, 99mTc, 51Cr and 131I.

Our staff include:

  • Radiopharmacy technician
  • Radiopharmacy consultant
  • Radiation protection supervisor (RPS)
  • Radiation protection advisor (RPA)

We QP release all radiopharmacy doses

  • Registered with the Royal Pharmaceutical Society of Great Britain since 2003
  • Registered with the General Pharmaceutical Council since 2011
  • MHRA Accreditation for Phase 1 Clinical Trials
  • MHRA Specials Licence
  • MIA(IMP) licence since May 2004 – inspected by the MHRA biannually since
  • HM Revenue & Customs authorisation to receive duty-free solvents
  • Licence to possess and supply Schedule 2, 3 and 4 (part 1 and 2) Controlled Drugs
  • Licensed for radiolabelled studies
  • ISO: 9001 certified quality management system
  • 4 QPs

Discuss your clinical trial pharmacy requirements

Whether you’re planning a first-in-human study, need specialist GMP pharmacy support or require Qualified Person (QP) release, our London team can help.

Speak with our clinical trial pharmacy specialists about your investigational medicinal product requirements, timelines and study objectives.

Speak with our London team