2020 ISPE Europe Biotechnology Conference

How ATMPs, Aseptics and Drug Products Meet Digitalisation

Biologics continue to develop into the most important group of medical drugs in the future. The market share value is steadily growing, new therapeutic approaches offer new possibilities to more successful treatment of severe diseases.

In Amsterdam, the new location for the European Medicines Agency, this October, ISPE will continue the series of successful biotechnology conferences featuring the 2020 ISPE Europe Biotechnology Conference. However, due to COVID-19 the event will be available on-line omly. Case studies will be presented, from concepts to industrialisation. Plant tours to new, state-of-the-art facilities will be offered, and the conference will be followed by a workshop where current industry practise and new ways of operations, e.g.

• How to build a Contamination Control Strategy to prevent product contamination during the process?
• How to design a facility, workshop to make ATMP’s with manual aseptic processes and avoiding product contamination during production?

In particular, the group of Advanced Therapy Medicinal Products (ATMPs) have particular GMP regulations linked to Annex 2 from PIC/S. “How to ensure that the GMP requirements for the manufacturing of biologics are met?” is one of the most important questions asked when companies invest in manufacturing facilities. The conference will highlight the differences between EC GMP Guide and the Annex 2 from PIC/S.

New technology platforms and the wave of digitisation will open innovative ways for process analysis, process verification and overall process control. The ISPE Pharma 4.0 approach will demonstrate elements and enablers but also roadmaps for implementation in biological manufacturing.

Data science - and process science concepts are key enablers for stable processes and a premise for continuous product supply. The conference will focus on how this can be successfully achieved.

See ISPE website for details and regstration.

Virtual Plant Tour: Produlab Pharma

Included in your conference registration is an exclusive facilities tour with Produlab Pharma (PP). PP is a Dutch, privately owned contract manufacturing organisation that operates a new facility at their premises in Raamsdonksveer, The Netherlands, for the production of animal health care products.