AGC Biologics has collaborated with biotechnology company Quell Therapeutics to advance the development of several T-regulatory (Treg) cell therapy drug candidates to treat severe immune disorders.
The collaboration will see AGC Biologics offer lentiviral vector (LVV) material leveraging its ProntoLVV platform, which will be instrumental in preparing the therapies for clinical trial application (CTA)/investigational new drug application (IND) submissions.
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Quell Therapeutics focuses on developing immune and inflammatory disorder treatments by leveraging the Tregs’ properties for restoring balance in the immune system.
The Milan Cell and Gene Center of Excellence at AGC Biologics will produce LVV material for Quell’s Treg cell therapy candidates.
Using its platform process, AGC Biologics is set to integrate Quell’s gene of interest into standardised production protocols.
This includes the use of off-the-shelf starting materials and provides flexibility for adhesion and suspension systems.
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By GlobalDataThe approach ensures good manufacturing practice (GMP) readiness and ease the shift into GMP manufacturing and trials.
The Milan Cell and Gene Center of Excellence has produced various GMP batches.
It is authorised for commercial manufacture by the European Medicines Agency and the US Food and Drug Administration for VV and cell therapies.
AGC Biologics global cell and gene technologies executive vice-president Luca Alberici said: “Our ProntoLVV platform is well-suited to support Quell in advancing its Treg cell therapies toward clinical trials.
“By combining standardised processes with the strong technical expertise of our scientific teams at the Milan site, we will work closely with our partners at Quell to help them streamline the development of these therapies while delivering the high-quality LVV material essential for CTA/IND submissions.”
The cell and gene technologies division of AGC Biologics assists partners in expediting their development timelines for drugs.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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