Nanoform granted GMP certification

By Jenni Spinner

- Last updated on GMT

(Image: Nanoform)
(Image: Nanoform)

Related tags Manufacturing API Manufacturing education

The Finnish nanoparticle technology specialist’s facility has been given the stamp of approval by the Finnish Medicines Agency.

Nanoform Finland has landed a Good Manufacturing Practices (GMP) certification from the Finnish Medicines Agency (FIMEA). With this certification, the company now can manufacture an investigational drug using its Controlled Expansion of Supercritical Solutions (CESS) nanoparticle engineering platform for use in clinical trials.

According to the company, the GMP designation represents an important milestone for its CESS nanoparticle technology, which reportedly reduces the size of active pharmaceutical ingredient (EPI) particles to less than 200 nm, and in some instances as small as 10 nm. This can help improve dissolution rates and bioavailability of drugs.

Edward Hæggström, Nanoform CEO, said achieving GMP status is important for the company

This facility represents the first GMP nanoforming capability in the world, and we look forward to supporting an increasing number of clients with their drug development projects and providing patients with faster access to life-changing treatments​,” he said.

Nanoform’s head of manufacturing David Rowe said the certification signifies the firm is ready to deliver ingredients necessary to develop advanced treatments.

By securing our first GMP licence, and employing cutting-edge manufacturing methodology, we are ready to deliver ‘designed-for-purpose’ API nanoparticles to the pharma industry for developing the next generation of medicines for patients​,” Rowe said.

In March, Nanoform announced a partnership with Orion​, a Finnish pharmaceutical company, to use the CESS nanoparticle technology in its operation.

Related news

Show more

Related products

show more

Increasing the Bioavailability of Oncology Drugs

Increasing the Bioavailability of Oncology Drugs

Content provided by Lonza Small Molecules | 13-Nov-2023 | White Paper

Oral tyrosine kinase inhibitors (TKIs) are a class of cancer drugs that can be highly susceptible to issues with solubility in the gastrointestinal tract

Efficient Freezing & Storage of Biopharmaceuticals

Efficient Freezing & Storage of Biopharmaceuticals

Content provided by Single Use Support | 06-Nov-2023 | White Paper

Various options exist for freezing biopharmaceutical bulk material, but selecting the most effective and efficient approach for each cold chain can be...

Related suppliers

Follow us

Products

View more

Webinars