Upperton gains MHRA approval for manufacturing in Nottingham
Drug Approval
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Source: Pharmaceutical Technology
Upperton Pharma will move from R&D to GMP production and commercialisation on a single site. Credit: Upperton Limited.
UK-based contract development and manufacturing organisation (CDMO) Upperton Pharma Solutions has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its facility in Nottingham.
The approval, granted following an MHRA inspection, marks the expansion of the company’s capabilities at this newly commissioned 50,000ft² development and GMP [good manufacturing practices] facility.
Upperton Pharma completed the construction, commissioning, validation and approval process for the unit within 18 months.
The CDMO will develop oral, nasal and pulmonary drug assets, offering Phase I, II, and III clinical supplies.
Upperton Pharma will move from research and development (R&D) to GMP production and commercialisation on a single site.
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The facility’s recent investment in large-scale process equipment, including a Gerteis mini-pactor, a GEA post-hoist blender, an O’Hara M50 tablet coating system and a ZANASI 40 capsule filler, will aid Upperton Pharma in handling batch sizes up to 250kg.
Its capability covers a broad range of dosage forms such as liquids, solids, semi-solids and inhaled pharmaceuticals, including potent molecules and controlled drugs.
With 24 years of experience, Upperton Pharma provides early drug development solutions to clients worldwide.
The company has formulation and analytical development laboratories, GMP manufacturing and quality control testing capabilities. It is licensed by the MHRA for manufacturing clinical trial material supplies.
It also has expertise in spray drying, a technique used to address challenges with poorly soluble molecules, and as a particle engineering technology for targeted pulmonary and nasal drug product deposition.
Upperton Pharma Solutions CEO Nikki Whitfield stated: “We are absolutely delighted to achieve this milestone.
“We have been conducting manufacturing scale-up activities since the start of the year following the installation of the larger-scale solid oral dosage form process trains and this gives the green light for our GMP facility to support clients right through to late-phase clinical manufacture and product registration.”
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