• Company
  • News
  • Investors
  • Contacts
  • Careers
PPTPPTlogo-mobilePPT
  • Services
    • GMP Compliance
    • Pre-GMP development
    • Production
    • Quality Assurance
    • Quality control
    • Regulatory Support
  • Generic peptides
  • Commercial Manufacturing
    • Commercial products at PolyPeptide
    • Late stage development
    • Process development and optimization
    • Capacity and Capabilities
  • Custom R&D
    • Custom Research Grade Peptides
    • Radiolabeled peptide
  • Cosmetic
  • Individualized Peptides
  • Oligos
  • Services
    • GMP Compliance
    • Pre-GMP development
    • Production
    • Quality Assurance
    • Quality control
    • Regulatory Support
  • Generic peptides
  • Commercial Manufacturing
    • Commercial products at PolyPeptide
    • Late stage development
    • Process development and optimization
    • Capacity and Capabilities
  • Custom R&D
    • Custom Research Grade Peptides
    • Radiolabeled peptide
  • Cosmetic
  • Individualized Peptides
  • Oligos
  • Home
  • News
  • Business news
  • FluoGuide reaches milestone with FG001 for phase III clinical supply

FluoGuide reaches milestone with FG001 for phase III clinical supply

9 November 2022
Business news

“We are thankful for the opportunity to work with FluoGuide on the highly innovative FG001 project and congratulate the whole team for reaching this milestone.”

Copenhagen, Denmark, 8 November 2022 – FluoGuide A/S (“FluoGuide” or the “Company”) is pleased to inform that the first large scale batch for its lead product FG001 has been successfully manufactured in preparation for phase III clinical development. 

FluoGuide has successfully collaborated with its supplier PolyPeptide since the very first synthesis of the FG001 API (Active Pharmaceutical Ingredient). FG001 is a clinical development project that was started in 2020 for the novel treatment of aggressive brain cancer. A first large scale batch has now been successfully manufactured by PolyPeptide in preparation for phase III clinical development.

For the pivotal phase III clinical trials, FluoGuide with the support of PolyPeptide has scaled up the manufacturing of FG001 to commercial scale. As part of the clinical process, FluoGuide now plans for three validation batches in commercial scale to be documented and included in the registration package for commercial approval.

Obtaining success with the first Phase III batch is therefore an important milestone for the preparation of any phase III trials and commercialization of FG001.

Morten Albrechtsen, CEO FluoGuide says “The completion of the first large scale GMP batch is a milestone for our lead product FG001, as it paves the way towards the next clinical steps and bringing us closer to commercialization”.

Neil Thompson, Director Global Sales and Marketing, PolyPeptide says: “We are thankful for the opportunity to work with FluoGuide on the highly innovative FG001 project and congratulate the whole team for reaching this milestone.”

For more information see press release

Back to news

Related posts

28 June 2022

PolyPeptide wins Malmö Life Science Business Award


Read more
22 December 2021

Efficient and sustainable solutions for large scale peptide manufacturing


Read more
11 May 2021

Proclamation honoring Jane Salik upon her retirement


Read more

Polypeptide Group

INFO

COMPANY
LEADERSHIP
CONTACTS
CAREERS

NEWS

LATEST NEWS
SIGN UP FOR NEWS
EVENTS

SOCIALS

LINKEDIN
YOUTUBE
© Confidentiality 2021 PolyPeptide Group • Cookie management • Personal data • Sitemap • Confidentiality policy
      By clicking “Accept”, you consent to the use of ALL the cookies on our website . However you may visit Cookie Settings to provide a controlled consent.
      Cookie settingsACCEPT
      Privacy & Cookies Policy

      Privacy Overview

      You can enable or disable your consent for each category of cookie.

      More information on the collection of personal data
      Necessary
      Always Enabled

      The necessary cookies help to make a website usable by enabling basic functions such as page navigation and access to secure areas of the website. The website cannot function properly without these cookies.

      Advertisement

      Marketing cookies are used to track visitors through websites. The goal is to display ads that are relevant and interesting to the individual user and therefore more valuable to third-party publishers and advertisers.

      Analytics

      Statistical cookies help website owners, through the anonymous collection and communication of information, to understand how visitors interact with websites.

      Performance

      Preferences cookies allow a website to retain information that changes the way the site behaves or displays, such as your preferred language or the region in which you are located.

      Save & Accept