• Company
  • News
  • Investors
  • Contacts
  • Careers
  • 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
  • Expert views
  • From 10 grams to several hundred – A case study in peptide GMP process development

From 10 grams to several hundred – A case study in peptide GMP process development

17 October 2022
Expert views

Presentation from TIDES digital week, September 2022, by Niall McLoughlin, PhD, Development Project Chemist at PolyPeptide Group.[…]

As a Contract Development & Manufacturing Organization (CDMO) of GMP-grade peptides, a central activity at PolyPeptide Laboratories is the development of robust and scalable manufacturing processes. Here, we present a case study describing the process development and the first GMP production of a 25-mer linear peptide which had only ever been previously manufactured in non-GMP batches up to 10 grams. We provide insight into a typical process development cycle and underline the key criteria which allowed for the definition of synthesis and purification conditions. Informed by results of our process development, we show how small adjustments applied to the GMP production campaign significantly improved both the yield and purity, enabling the isolation of several hundred grams of peptide API.

Back to news

Related posts

22 September 2022

Green Chemistry Articles of Interest to the Pharmaceutical Industry


Read more
13 March 2022

Green Chemistry Articles of Interest to the Pharmaceutical Industry


Read more
28 February 2022

Environmentally Sensible Organocatalytic Fmoc/t Bu Solid-Phase Peptide Synthesis


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