Release of first GMP drug substance for an ABZENA Inside product manufactured by Abzena - Abzena

Release of first GMP drug substance for an ABZENA Inside product manufactured by Abzena

8 August 2018

Cambridge, UK, 8 August 2018 – Abzena plc (AIM: ABZA, ‘Abzena’), the life sciences group providing services and technologies to enable the development and manufacture of biopharmaceutical products, has completed the GMP drug substance manufacture of an ABZENA Inside product that was originally humanised utilising Abzena’s Composite Human Antibody platform™. The product is a novel therapeutic antibody, Clevegen®, being developed by clinical stage biotechnology company, Faron Pharmaceuticals.

The manufacture of this product took place at Abzena’s site in San Diego, CA but utilised significant bioanalytics and bioassay expertise from Abzena’s Cambridge, UK site including product characterisation, binding, potency and stability assays.

The bulk drug substance has now been released by Abzena for fill-finish with a third party.

Jim Mills, SVP Technical Operations of Abzena, said:

 “We are pleased to have enabled the progression of an ABZENA Inside antibody towards clinical development through this partnership.

 It really demonstrates the depth of our integrated services and technologies, showing how our sites work together to provide the support that our partners require to move their products forward from molecule design into clinical trials.”

 Enquiries: 

Abzena plc

John Burt, Chief Executive Officer

 

+44 1223 903498

Instinctif Partners

Melanie Toyne Sewell / Rozi Morris / Alex Shaw

 

+44 20 7457 2020

abzena@instinctif.com

 Notes to editors

 About Abzena

Abzena (AIM: ABZA) provides proprietary technologies and complementary services to enable the development and manufacture of biopharmaceutical products.

The term ‘ABZENA Inside’ is used by Abzena to describe products that have been created using its proprietary technologies and are being developed by its partners, and include Composite Human Antibodies™ and ThioBridge™ Antibody Drug Conjugates (ADCs). Abzena has the potential to earn future licence fees, milestone payments and royalties on ABZENA Inside products.

Abzena offers the following services and technologies across its principal sites in Cambridge (UK), San Diego, California (USA) and Bristol, Pennsylvania (USA):

  • Biology research studies, including immunogenicity assessment of candidate biopharmaceutical products and bioassay development;
  • Protein engineering to create humanized antibodies and deimmunised therapeutic proteins;
  • Cell line development for the manufacture of recombinant proteins and antibodies;
  • Contract process development and GMP manufacture of biopharmaceuticals, including monoclonal antibodies and recombinant proteins for preclinical and clinical studies;
  • Contract synthetic chemistry and bioconjugation research services focused on antibody-drug conjugates (ADCs);
  • Proprietary site-specific conjugation technologies and novel payloads for ADC development;
  • GMP manufacturing of ADC linkers, payloads & combined linker-payloads; and
  • GMP analytical services for biopharmaceutical manufacturing projects.

For more information, please see www.abzena.com.

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