MIDATECH PHARMA
Technologies | Manufacturing

Midatech's Nanoparticle Manufacturing Facility

 

Corporate Video

Midatech operates an in-house nanoparticle manufacturing facility, which is believed to be the first licensed nanopharmaceutical cGMP facility of its kind in Europe. This state-of-the-art facility based in Bilbao, Spain, aids in the rapid execution of projects, control of manufacturing quality and supply of all aspects of Midatech’s development platform, thus avoiding reliance on external manufacturing partners.

The site has capacity for manufacturing sufficient materials for clinical trials and is fully licensed by the Spanish Medicines Agency for European compliance. The facility underwent a €800,000 upgrade in September 2014 to enable the production of sterile material for use in human clinical trials and initial phase manufacturing of licensed product.

In 2014, an international consortium led by Midatech was selected to receive a €7.9 million Horizon 2020 European Union grant for its “Nanofacturing” Project to fund the manufacturing scale-up of clinical-grade therapeutics based on its GNP drug conjugate technology and other nanopharmaceuticals, for use in clinical trials. Part of this grant was used to co-fund a €1.2m investment in equipment and installations in 2016 to enable full final product manufacture, making the Midatech plant completely autonomous for supporting its pipeline through clinical trials in preparation for commercial production and supply. In parallel, Midatech incorporated its state of the art microsphere manufacturing process into the plant to produce these new products for clinical trial. Regulatory approval for full final product manufacture of both nanopharmaceutical and microsphere products is on track to be obtained in 2017 following a third successful regulatory inspection at the end of 2016. These investments in additional resources enable Midatech to capture more of the integrated value chain and meet the pre-clinical and clinical manufacturing needs in-house for its entire development pipeline and provide the most cost-effective development option for its Investigational Medicinal Product (IMP) portfolio.

Midatech is also able to leverage this facility to manufacture for other non-competing nanomedicine businesses, representing additional revenue-generating opportunities.

Technologies
Manufacturing

Midatech's Nanoparticle Manufacturing Facility

 

Corporate Video

Midatech operates an in-house nanoparticle manufacturing facility, which is believed to be the first licensed nanopharmaceutical cGMP facility of its kind in Europe. This state-of-the-art facility based in Bilbao, Spain, aids in the rapid execution of projects, control of manufacturing quality and supply of all aspects of Midatech’s development platform, thus avoiding reliance on external manufacturing partners.

The site has capacity for manufacturing sufficient materials for clinical trials and is fully licensed by the Spanish Medicines Agency for European compliance. The facility underwent a €800,000 upgrade in September 2014 to enable the production of sterile material for use in human clinical trials and initial phase manufacturing of licensed product.

In 2014, an international consortium led by Midatech was selected to receive a €7.9 million Horizon 2020 European Union grant for its “Nanofacturing” Project to fund the manufacturing scale-up of clinical-grade therapeutics based on its GNP drug conjugate technology and other nanopharmaceuticals, for use in clinical trials. Part of this grant was used to co-fund a €1.2m investment in equipment and installations in 2016 to enable full final product manufacture, making the Midatech plant completely autonomous for supporting its pipeline through clinical trials in preparation for commercial production and supply. In parallel, Midatech incorporated its state of the art microsphere manufacturing process into the plant to produce these new products for clinical trial. Regulatory approval for full final product manufacture of both nanopharmaceutical and microsphere products is on track to be obtained in 2017 following a third successful regulatory inspection at the end of 2016. These investments in additional resources enable Midatech to capture more of the integrated value chain and meet the pre-clinical and clinical manufacturing needs in-house for its entire development pipeline and provide the most cost-effective development option for its Investigational Medicinal Product (IMP) portfolio.

Midatech is also able to leverage this facility to manufacture for other non-competing nanomedicine businesses, representing additional revenue-generating opportunities.

© Copyright 2017 Midatech Pharma PLC