In collaboration with Cook Regentec and Terumo BCT, the Centre for Cell Manufacturing Ireland (CCMI) has set up a workshop around the key manufacturing activities, Scale-Up and challenges, including reguilatory, for Advanced Therapeutic Medicinal Products (ATMPs).
ATMPs are at the forefront of regenerative medicine to solve the unmet need of patients. Rather than a typical pharmaceutical manufacturing process, manufacturing of ATMPs can be complicated and challenging. How the manufacturing process is designed and controlled directly correlate with the safety and efficacy in patients and also correlates to inputs such as starting and raw materials. Characterization of the ATMP during all stages of development, wither process or analytical, is crucial for compliance and producing a safe product. The aim of this meeting/workshop is to unravel the different manufacturing methods currently used in the manufacture of ATMPS across Europe and the USA, as well as exploring the option of scale-up for the manufacturing process. Traditional cell culture based methods of tissue culture vessels will need to advance to large scale bioreactors in order to meet the need and demand for ATMPs. The raw materials are also crucial for the manufacturing process and identifying alternatives, like serum free medias, will facilitate the complete manufacturing process. Regulatory challenges will also be discussed.
The workshop will allow users hands-on experience with Terumo Quantum Bioreactor and Cook Regentecís HemaTrate Cell isolation device and CellSeal closed-system cryopreservation technology, including upstream fill/finish options (including automation) and downstream controlled thawing. A certificate of attendance will also be supplied to each attendee.
At the end of this workshop, the attendees will have a greater understanding of the manufacturing process involved in ATMP manufacturing, the scale-up and expansion possibilities available for large scale manufacturing as well as identifying potential regulatory challenges and risks involved in the manufacturing of ATMPs.