Dutch ATMP Summit Manufacturing
Dutch ATMP Summit Manufacturing
2022
2022
Recap of the day
The number of novel therapies in development based on ATMPs is rapidly increasing over the last five years. In parallel specific regulations and guidance have been put in place to assure quality, safety and efficacy of ATMP products. The first edition of the Dutch ATMP Summit is focusing on specific quality and safety aspects related to manufacturing of ATMPs to ensure the quality and safety of these product manufactured for often critically ill patients.
On average the participants of the 2022 edition rated the Dutch ATMP Summit with a 7,6
- “A good opportunity to meet and discuss ATMP’s and meet people/companies dealing with ATMP’s”
- “Good to have the basics explained in a general and easy to understand way”
- “Nice overview of different topics related to ATMP”
- “Nice interactive in depth discussion”
- “Very informative and intimate”
Some of the participants of the 2022 edition
Speakers
Piergiuseppe Nestola
Manager of process technology consultants
Sartorius Stedim Biotech
Speakers
Piergiuseppe Nestola
Manager of process technology consultants
Sartorius Stedim Biotech
Topics of the summit
Presentations
Impact of single use technologies into the bioprocessing of viral vectors. Viral vectors have become one of the most rapidly evolving and promising fields in vaccinology and ATMPs. As the industry continues to grow, biomanufacturers are developing, optimizing and scaling-out production processes to establish or expand viral vector production facilities. We believe there is a significant opportunity for the industry to benefit from a platform-approach to produce viral vectors and live-viruses. In this presentation, we will discuss how a single use platform approach allow firms to reduce the time required to bring their products to the clinic and the market, and provide you with consistent process performance. We will describe the toolbox of technologies and services proven to be efficient in the development, production and analysis viral vectors processes.
Viral control strategies
Assurance of viral safety of biological products including ATMPs, has been a primary objective during evaluation of safety of these candidate medical products by regulatory authorities, also during early development. Appreciating the nature of ATMPs not all established complementary measures to assure viral safety can be applied. This presentation will provide specific cases of ATMP products, finding optimal balance between complementary measures for viral safety assurance i.e. control of raw materials, testing of starting materials and intermediates, validation of viral clearance during downstream processing, and viral risk assessments.
Lay-out development for the facility
This presentation will provide considerations for arriving on an optimal lay-out of an ATMP commercial production facility that is compliant with EU-GMP regulatory requirements for ATMP production. We will focus on the specific challenges in ATMP production facilities, on how to set-up the segregation strategy and on how to translate the demands into a GMP compliant facility design.
Chain of Custody
This presentation will provide an outline of EU-regulatory requirements for registration, accreditation, or licensing of all ‘stations’ involved in obtaining, storing and processing human cellular material in the chain of steps from donation to manufacture of an Advanced Therapy Medicinal Product and transfer to the hospital for administration to the involved patient.
