CTM manufacturing

CTM Manufacture

Clinical Trial Manufacturing at Pharmaterials

Pharmaterials state of the art GMP facility has 13 manufacturing rooms allowing for the manufacturing of non-sterile dosage forms for Oral, Inhaled and Topical routes of delivery.

The licensed Investigational medicinal product (IMP) Facility comprises of 3 manufacturing rooms controlled to grade D and 10 newly completed manufacturing rooms controlled to grade C.

 

Manufactured Dosage Forms
  • Powder in Capsule using Xcelodose Technology
  • Powder blends filled into hard shell capsules, bottles or inhalation devices.
  • Granules filled into hard capsule shells or bottles.
  • Tablets and bilayer tablets .
  • Liquids or suspensions filled into bottles, sachets or pMDIs.
  • Amorphous formulations filled into hard shell capsules or tablets.
  • Liquid or semi-solid formulations filled into hard shell capsules.
  • Topical creams and ointments.
Other GMP Process
  • Microfluidisation
  • Hot Melt Extrusion
  • Film Coating
  • Granulation – aqueous and non-aqueous, dry or melt
  • Low dosage powder filling into capsules (micro – milligram quantities)
Equipment

Pharmaterials have a range of equipment for encapsulation, tableting, milling, blending, spray drying and coating.

  • Harro Höfliger Modu-C LS Automated Encapsulation Filling Machine
  • Xcelodose 600 Encapsulation Machine with size 00, 0 1, 2, 3 and 4 change parts. This technology can be used to fill small quantities of API alone into capsules for clinical testing, with little or no formulation, allowing rapid progress to the clinic.
Good Manufacturing Practice (GMP)

We perform Development in compliance with the principles and guidelines of GMP as laid down in Commission Directive 2003/94/EC, by the Medicines and Healthcare Products Regulatory Agency (MHRA). The Manufacture of Investigational Medicinal product and associated analytical procedures fully comply with annex 13 of the Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007.

Manufacturing equipment and laboratory instrumentation is subject to our comprehensive qualification process (IQ/OQ/PQ). Calibration, validation and preventative maintenance is independently monitored by Quality Assurance. Our Investigational Medicinal Product Manufacturing facility has been inspected and approved by the Medicines and Healthcare Products Regulatory Agency (MHRA).

Please contact us for full details of this service.