Clinical Manufacturing

Clinical Supplies Manufactured with Compliance and Quality

Upperton offers a flexible and dynamic approach to GMP manufacturing. From first in human (FIH) through to phase III clinical supplies manufacturing. No project is too small or too challenging.

Upperton has been granted licences from both the Medicines and Healthcare products Regulatory Agency (MHRA) and the Home Office (controlled drugs I-IV)

Upperton MHRA Licence: Scope of Activities

Clinical Manufacturing Scope of Activities

In our MHRA approved facility, we offer manufacturing and packaging of Investigational Medicinal Product (IMP) in dosage forms including oral solid dosage forms, bulk dry powders, dry powder inhalers, nasal suspensions and solutions; for both biological molecules and traditional small molecules. Placebo development and manufacture are also offered.

GMP Clean Room Facilities

 

We currently have 3 x Grade D/ISO 8 manufacturing rooms with 2 x Grade C/ISO 7 downflow booths for manufacturing of a wide range of dosage forms including

  • Bulk spray dried powders
  • Capsules
  • Tablets
  • Dry Powder Delivery Devices (nasal and pulmonary)
  • Liquid Delivery Devices (nasal and pulmonary)
Clinical Manufacturing Clean Room Facilities

Where necessary, localised isolator technology can be utilised for operator protection (eg when handling more potent molecules) or for reducing bioburden when manufacturing liquid formulations.

Processing Technologies

Our manufacturing suite is incredibly flexible with a wide range of mobile equipment that can be brought in and out of our facility depending on our customers processing requirements. Here are some of the processing technologies that we have available

  • Granulation
    – GP1 High shear Mixer granulator (10 L)
    – TFC micro roller compactor

  • Blending
    – Pharmatech MB30 – up to 30 Kg

  • Compression
    – Futorque Rotary machine 130,000/H

  • Coating
    – O’Hara LC M5 multi pan coater (5 kg)

  • Capsule / Device filling
    – Quantos, 3P F2W Bonapace INCAP (3000/hr)

  • Spray Drying
    – ProCepT spray dryer (100 mg to 200 g)
    – SD Micro Spray dryer (10 g to 500 g)
    – GEA Niro PSD1 (50 g to 3 kg)
Clinical Manufacturing Processing Technologies

For more details on the range of manufacturing capabilities and processes that we can offer, please download our Technical Services Fact Sheet

Pre-formulation Studies

Upperton’s formulation development team will confidently guide you on the best route forward.

Formulation Development

Utilise our expertise and know-how to solve problems unique to your challenging molecule.

Oral Dosage Forms

Development of oral dosage forms containing spray dried powders. Including tablets, capsules, sachets and vials.

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