iSpeak Blog

ATMPs from Proof of Concept to Commercial Manufacturing

Nikhe Bartelt
Richard Denk
Source: SKAN – Isolator for Cell and Gene therapy with integrated fast decontamination airlock (less than 3min), Centrifuge, and Incubator

Welcome fellow ISPE Bio Manufacturing members, sponsors, industry professionals, or those interested in the manufacturing of Cell and Gene Therapies! It is our pleasure to invite you to the 2023 ISPE Biotechnology Conference in Dublin, Ireland. In Track 3 of the conference, we will introduce you to the concept and commercialisation of ATMPs and cell and gene therapy.

2023 ISPE Biotechnology Conference

Recap for Our Newcomers: Advanced Therapy Medicinal Products, Cell and Gene Therapy

Surely, you have heard about cell and gene therapy. While cell therapy utilises cells to repair, regenerate or replace damaged tissue, gene therapy involves the introduction or modification of genetic material to treat or prevent diseases. Cell and gene therapy has been used to treat various types of diseases, including cancer, neurological disorders, autoimmune diseases, genetic disorders, and viral infections. Cell-based and gene therapy products, such as advanced therapy medicinal products (ATMPs), have become a game-changer in individual therapy as they pave the way for a new era in medical treatment. ATMPs, which are based on genes, tissues, or living cells, include gene therapeutics, somatic cell therapeutics, and tissue-engineered products.

ATMPs offer a range of benefits over traditional drugs and therapies. Not only do they provide long-lasting effects after single treatments, but they also reduce side effects as they are designed to target specific cells or tissues. ATMPs are used to treat diseases that have no other conventional treatment option available. They represent a new class of medical products with the potential to transform the treatment of diseases and open pathways in research and development.

Track 3 - ATMPs/C&GTs

The potential for ATMPs and C&GTs to revolutionise medicine is already having an impact on current treatments. This presents new challenges in commercial manufacturing and large-scale production. Don’t miss our upcoming track if you are interested in learning about how these groundbreaking treatments are being brought to the masses. Our speakers will give insights on hospital manufacturing and commercial manufacturing of ATMPs/C&GTs, including networking opportunities and a panel discussion with all speakers from the track featuring Peter Marks from the FDA as a special guest speaker. Mark your calendar and dive into the fascinating world of advanced therapy medicinal products!

Our Programme

The track and panel discussion will be led by Aoife Catherine Corcoran, Janssen Biologics (Ireland); Richard Denk, SKAN AG; Antonio R. Moreira, PhD, University of Maryland; Nikhe Bartelt, ISPE student chapter TUM and will feature as speakers: Stephen Judd, DPS Group; Sebastian Trennheuser together with Thorsten Haefner, PSM GmbH; Andrew Finnerty, Centre of Cell Manufacturing Ireland; Sanjeev Kumar Raman, APC; William G. Whitford, DPS Group.

From Hospital to Commercial Manufacturing: From the Centre of Cell Manufacturing Ireland (CCMI), Andrew Finnerty will offer the audience insights into the challenges of commercialising cell and gene therapy treatments that have so far been state-EU funded. CCMI is part of an established supply chain for ATMP products and has delivered several clinical programs aimed at offering patients alternative treatments through advanced therapies.

Development of a Commercially Scalable Oncolytic Vaccine Production Process for Viral Immunotherapy: APC Scientist Sanjeev Kumar Raman will introduce to us a scalable manufacturing process for an ATMP, a novel oncologic vaccine produced in adherent cells. We will be briefed on the methods and impacts of the increase in production of this ATMP.

Commercial Manufacturing of ATMPs: Takeda Alofisel Case Study: A case study presentation on the Takeda Alofisel 2021 ISPE FOYA Winner will exhibit case studies on modular building facilities on their sites in Osaka, Japan; Thousand Oaks, California, USA; and Grange Castle, Ireland.

Flexible and Multi-Modal ATMP Facilities: DPS Group speakers Stephen Judd and William G. Withford will be discussing flexible and multi-modal facility design considerations for ATMP manufacturing. They will highlight the potential and determining factors of facility design.

Processing of ATMPs at a German CDMO — Scale-up of a viral vector fill & finish project from bench top to fully automated processes: The processing of ATMPs will be brought to us with an example of a viral vector fill and finish project by Sebastian Trennheuser and Thorsten Haefner from PSM GmbH.

Comparison of the Manufacturing of ATMPs applying PIC/s Annex 2 A for ATMPs and EU GMP Annex 1: Before the panel discussion, a comparison of the manufacturing of ATMPs applying PIC/s Annex 2 A for ATMPs and EU GMP Annex 1 will be presented by the University of Maryland, Baltimore County (UMBC).

To Close…

Stay tuned for more updates on the 2023 ISPE Biotechnology Conference in Dublin, Ireland. ATMPs have a huge potential to revolutionise medical treatment. Our Track 3 lineup of expert speakers will provide you with valuable insights on hospital manufacturing to commercial manufacturing of ATMPs/C&GTs.

Thank you to our field experts and special guest panelist, Peter Marks from the FDA, for sharing their expertise with us. We are looking forward to gaining valuable first-hand knowledge and unique networking opportunities with our experts and the audience.1 ,2 ,3 ,4 ,5 ,6

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