Nanoform receives GMP certification

Published: 4-May-2020
Regulatory

The Finnish Medicines Agency has awarded Nanoform a GMP certificate for it proprietary CESS nanoparticle engineering platform

Nanoform Finland, an innovative nanoparticle medicine enabling company, has been awarded a Good Manufacturing Practices (GMP) certification by the Finnish Medicines Agency, FIMEA. Achieving GMP status permits Nanoform to manufacture an investigational drug, developed using its proprietary CESS nanoparticle engineering platform, for use in clinical trials.

The GMP certification represents a very important milestone for Nanoform as it continues to increase the commercial reach of its CESS technology, which reduces the size of API particles to less than 200nm (and in some cases as small as 10nm) to improve dissolution rates and bioavailability. This unique capability addresses a major cause of attrition within the pharma industry.

Prof Edward Hæggström, Nanoform CEO, said: "Achieving GMP status constitutes another landmark moment in Nanoform's history. 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."

Dr David Rowe, Head of Manufacturing, said: "I am incredibly excited that we have been awarded GMP status to supply nanoformed API for use in human trials. 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."

  • Companies:
  • Nanoform
See more

You may also like

Manufacturing

Nanoform reveals recent GMP inspection results

Read more
FIMEA fully reviewed Nanoform for compliance with its processes and adherence to GMP for the manufacture of multiple clinical active pharmaceutical ingredients (APIs)

Trending Articles

  1. Accelerating and enhancing toxicology assessments Infographic guides users through ToxHQ’s speedy assessment features
  2. You need to be a subscriber to read this article.
    Click here to find out more.
    Merck jumps on the GLP-1 therapeutic bandwagon by licensing Hansoh Pharma's HS-10535 Merck will be responsible for the development, manufacture and commercialisation of the investigational preclinical oral GLP-1 receptor agonist
  3. Bayer's acoramidis recommended for approval by the EMA's CHMP for cardiomyopathy The orally administered transthyretin (TTR) stabiliser is suitable for patients with transthyretin amyloid cardiomyopathy, demonstrating at least a 90% TTR stabilisation capacity and a reduction in cardiovascular-related hospitalisations
  4. You need to be a subscriber to read this article.
    Click here to find out more.
    Why quality control should be intimately combined with sterile product development, manufacturing and the overall product supply chain With sponsor companies increasingly needing to create and launch differentiated, stable, usable and safe injectable treatments for patients, experts at ten23 health are keen to promote the importance of integrating development and/or manufacturing with quality control services
  5. The right validation model: practical considerations and applications It is widely accepted that validation in the life sciences industry follows a lifecycle model (1,2). What is not always clear is the specific model — or models — to follow and how to navigate through them in the real world. Hurdles to overcome include the specific deliverables that make up that model and how they change during the various interactions along the validation journey

Upcoming event

EMPQ Essentials and Real-World Strategies for Successful Cleanroom Qualifications

16 January 2025 | Virtual See all

You may also like

Manufacturing

Nanoform reveals recent GMP inspection results

FIMEA fully reviewed Nanoform for compliance with its processes and adherence to GMP for the manufacture of multiple clinical active pharmaceutical ingredients (APIs)
Regulatory

Nanoform receives ISO/IEC 27001:2013 certification for its Information Security

The ISMS applies to all information, systems, processes, and people that operate, store, handle, and process Nanoform’s and its clients’ trusted data
Regulatory

Nanoform signs GMP agreement and achieves near-term business target

Nanoform, an innovative nanoparticle medicine enabling company, announces it has signed an agreement to manufacture GMP (Good Manufacturing Practice) nanoformed material for a European headquartered international company. This follows the Letter of Intent (LOI), signed between the parties in June 2021, to nanoform and develop, manufacture, and commercialise an improved version of a current blockbuster drug
Regulatory

Research shows Nanoform method speeds up absorption and improves drug delivery

These results pave the way for improving absorption and increasing drug load while enabling simpler formulations to maximise patient benefit
Regulatory

Nanoform’s clinical study indicates positive interim results

The faster absorption data implies that small particles can be powerful
Regulatory

Accelerating and enhancing toxicology assessments

Infographic guides users through ToxHQ’s speedy assessment features
You need to be a subscriber to read this article.
Click here to find out more.
Regulatory

Merck jumps on the GLP-1 therapeutic bandwagon by licensing Hansoh Pharma's HS-10535

Merck will be responsible for the development, manufacture and commercialisation of the investigational preclinical oral GLP-1 receptor agonist
Subscribe now