The first edition of the Dutch ATMP Summit will all be about manufacturing. You will learn about the challenges and its solutions.
May 18th 2022, Hoofddorp
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.
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.
Program
12.30 – 13.00 registration & walk-in
We will start the program with a cup of coffee and some snacks
13.00 – 14.45 welcome & presentations
- Warm welcome from our CCO Edwin van den Bos
- Introduction of the host of the day, Kathinka van Hooren
- Frank van Engelenburg. He will teach you about the right viral control strategies
- Piergiuseppe Nestola. He will tell you all about the impact of single use technologies into the bioprocessing of viral vectors
14.45 – 15.15 coffee break
Enjoy some coffee and refreshments and get ready for the next part of the Summit
15.15 – 16.30 presentations
- Hans de Koning’s presentation provides an outline of considerations for the lay-out of an ATMP commercial production plant. How to design a facility compliant to the EU-GMP regulation requirements for ATMP production.
- Cor Marsman’s presentation is a short outline of EU regulatory requirements for registration or licensing of all ‘stations’ involved in obtaining, storing and preparing cellulair material to become an Advanced Therapy Medicinal Product.
16.30 – 16.45 round-up & closing of the Summit
A round up of the day.
16.45 – 18.00 Networking drinks
Time for a drink and some snacks. Of course you will have the possibility to talk to the speakers and ask them extra questions or just enjoy networking
Speakers
Piergiuseppe Nestola
Manager of process technology consultants
Sartorius Stedim Biotech
Speakers
Piergiuseppe Nestola
Manager of process technology consultants
Sartorius Stedim Biotech
Regular ticket
access to the Dutch AMTP Summit at May 18th 2022.
299,- excl VAT
Dutch ATMP Summit 2022
With this ticket you will get access the the Dutch ATMP Summit on Wednesday May 18th 2022 in Hoofddorp. You can join all the talks of our speakers and meet your colleagues in the field during networking drinks. During the day there are refreshments.
Regular ticket
access to the Dutch AMTP Summit at May 18th 2022.
299,- excl VAT
Dutch ATMP Summit 2022
With this ticket you will get access the the Dutch ATMP Summit on Wednesday May 18th 2022 in Hoofddorp. You can join all the talks of our speakers and meet your colleagues in the field during networking drinks. During the day there are refreshments.
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.
The first edition of the Dutch ATMP Summit will take place at the Courtyard Marriott Hotel.
Bosweg 15, 2131 LX Hoofddorp
About us
This summit is an initiative from Progress
We work together with our clients, in order to obtain their goals. We work as a team to reach to the top. Progress is an independent consultancy company with customers in the pharmaceutical and biotechnology industries and in the healthcare sector. We provide project management, engineering & C&Q, CMC and Quality services.
About us
This summit is an initiative from Progress
We work together with our clients, in order to obtain their goals. We work as a team to reach to the top. Progress is an independent consultancy company with customers in the pharmaceutical and biotechnology industries and in the healthcare sector. We operate internationally, project management, engineering & C&Q, CMC and Quality services.
