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

Manufacturing Drugs with Highly Potent APIs

Manufacturing Drugs with Highly Potent APIs

Content provided by Altasciences | 28-Sep-2023 | White Paper

In this issue of The Altascientist, we examine the critical considerations for the safe and compliant manufacture of drugs with highly potent APIs (HPAPIs),...

Unlock potential in buffer preparation

Unlock potential in buffer preparation

Content provided by Thermo Fisher Scientific - Process Liquid Preparation Services | 18-Sep-2023 | Infographic

Consider how the right partner can help you scale faster, mitigate risks, and optimize resources.

Plan for success with process liquid and buffer preparation

Plan for success with process liquid and buffer preparation

Content provided by Thermo Fisher Scientific - Process Liquid Preparation Services | 14-Aug-2023 | White Paper

Setting the groundwork for successful scale-up is essential for getting a therapeutic to market quickly and efficiently, but navigating the unknowns associated...

Related suppliers

Follow us

Products

View more

Webinars