Additionally, manufacturers are often tasked with utilizing legacy equipment. This session will also present a unique isolator decontamination approach.
Robust decontamination for ATMPs, especially for material transfer, has been challenging due to reagent penetration, time inefficiency, temperature increase and so on. This presentation introduces an innovative decontamination method called UltraDecon that can be applied to cell transfer. UltraDecon uses hydrogen peroxide with special ultrasonic for decontamination. This can reduce 6-log decontamination time to as fast as 5 minutes. Of course, this technology is applicable to pharmaceutical sterile manufacturing. Aging isolator can be upgraded with this new decontamination technology. Participants will learn a new decontamination method, which makes new concept of sterile manufacturing possible.
The presentation will showcase one project to introduce technology advancements in aseptic processing. It relates to a new device to be launched in the market which is composed of a freeze dried vial and an aseptically filled bag. The coupling of this two which will constitute the ready-to-mix device needs to take place in an aseptic environment. Due to this some new technology in the aseptic processing within isolator technology have needed to get implemented such as the VHP continous tunnel to have the freeze dried vials entering the Grade A environmnet and IV Bags decontamination. In particular being the first time of implementation of the VHP tunnel technology, performance verification methods as well as regulatory aspects had to be assessed during the project development.
Make vs. Buy in Gene and Cell Therapy and the update on PIC/S Annex 2A Revision for ATMPs will be the topics during this ATMP Session. Which considerations should be used in determining whether an advanced therapy company should manufacture therapies internally, utilize external third-party manufacturers or use a hybrid approach? This presentation from Project Pharma explores the rationale of cell and gene therapy companies using an external CMO or relying on internal manufacturing. Interview with Alyce Maksoud TGA (Therapeutic Goods Administration from Australia) and Francesco Cicirello Adaptimmune (former TGA Subject Matter Expert): Francesco Cicirello’s update on PIC/S Annex 2A Revision for ATMPs will provide a view of his former position as Senior Subject Matter Expert and GMP Inspector at the TGA in Australia and Chair of the PIC/S Annex 2 working Group about the challenges providing a Guideline for ATMPs. Alyce Maksoud, Team Leader Inspection Section, TGA MQB Australian Department of Health, PIC/S Chair of the Working Group on Tissue and Cells. The Interview with Alyce and Francesco will cover most ask questions related to Cell and Tissue Manufacturing. A must to attend for all working with ATMPs.
Which considerations should be used in determining whether an advanced therapy company should manufacture therapies internally, utilize external third-party manufacturers or use a hybrid approach? This presentation from Project Pharma explores the rationale of cell and gene therapy companies using an external CMO or relying on internal manufacturing.
Interview with Alyce Maksoud TGA (Therapeutic Goods Administration from Australia) and Francesco Cicirello Adaptimmune (former TGA Subject Matter Expert): Francesco Cicirello’s update on PIC/S Annex 2A Revision for ATMPs will provide a view of his former position as Senior Subject Matter Expert and GMP Inspector at the TGA in Australia and Chair of the PIC/S Annex 2 working Group about the challenges providing a Guideline for ATMPs. Alyce Maksoud, Team Leader Inspection Section, TGA MQB Australian Department of Health, PIC/S Chair of the Working Group on Tissue and Cells. The Interview with Alyce and Francesco will cover most ask questions related to Cell
Project Farma details the considerations used in determining whether an advanced therapy company should manufacture therapies internally, utilize external third-party manufacturers or use a hybrid approach. This discussion explores the rationale of cell and gene therapy companies using an external CMO or relying on internal manufacturing. With insight from an advanced therapy company that utilizes internal and external manufacturing, Project Farma provides the considerations for both cases.
