ISPE Europe Biotechnology Conference 2017

LSC’s Kieran, Annette and James are back in the office after exhibiting at the successful ISPE Europe Biotech Conference 2017 in Dublin.

The feedback from all attendees was extremely positive with many highlighting the high calibre of the presentations and the speakers. The event achieved it’s goal of exploring the “Biotechnology factories of the future” and the five megatrends in technology and regulatory development that will influence the industry.

Over the course of the two day seminar speakers covered a range of topics associated with the five mega trends in the Biopharma sector and a common theme emerged throughout – The need to reduce costs and get medicines to patients faster.

Below we look at the five megatrends in more detail.

Industry 4.0 and full automation

The complete replacement of human beings at the shop floor level and a movement to higher qualified people for production control strategies, process control and quality oversight.

A key part of the move to automated facilities is the need to increase and expand the skill set of the people on site. Dominic Carolan, CEO, NiBRT addressed workforce as a key success factor in future biologics manufacturing and presented an employee’s needs and perspective and how companies are addressing and adapting to them.

Christian Wolbeling, Senior Director Global Accounts, Werum IT solutions presented a strategic view on moving from Industry 4.0 to Pharma 4.0 and the need to adapt a more holistic approach to the implementation of the smart factory.

Product portfolios

As the Pharmaceutical industry moves towards biologics, biosimilars, gene therapies and personalised medicines what will this mean for the factories of the future as they adapt to a new healthcare delivery model.

Gerald Kierans, Director of Technical Services, Pfizer pharmaceuticals delivered a fascinating view on new ways to address patient needs. Bjorn-Philipp Kloke, Head of IVAC Technology Platform Engineering, BioNTech AG and Martin Zindler, Software Architect, BioNTech AG delivered a market view of individualised medicines and how the industry needs to change.

Smaller batches

New Biopharma facilities today are being designed for low/medium-volume-high-mix product manufacturing. This is driving new approaches to cleaning processes and validation and the need to consider new technologies i.e. single-use.

Richard Shah, Biopharmaceutical Engineer, Pfizer pharmaceuticals gave an insight into a working example of a 2k single-use mAB process area at Pfizer Grangecastle and Neomi Dorival Garcia, Senior Research Fellow, NIBRT presented an overview on the characterization of extractable and leachable in Bioprocessing single-use consumables.

Technology platforms

New technology platforms will see additional active substances like ADC (Antibody Drug substances Conjugating) with higher toxicity, requiring full containment in manufacturing processes and open product handling.

Michelangelo Canzoneri, Head of Technology and Innovation Therapeutic Proteins, Sanofi shared a systematic approach to a Biologics Innovation and Technology Management Process (BITMAP) which highlighted the need to establish a collective industry approach to ensure overall success of the process.

Continuous manufacturing

Continuous manufacturing is playing a major role in reducing time to market by excluding scale-up processes and related risks.

Rene Labtatut, VP-Head of Technology Innovation, Sanofi Pasteur addressed continuous manufacturing in Biopharmaceutical and the need to guarantee the highest level of quality and safety for the patient, while delivering the optimum performances for the company.

Both Diarmuid O’Connor, Plant Manager, Biotechnology Operations, Eli Lilly Kinsale and Mairead Looby, Director, Manufacturing Science & Technology Group, BMS Cruiserath presented excellent insights into their respective Biopharma facilities in Ireland and the opportunities and energy on both sites as they look into the future and consider a Biologics market that is set to continue to grow.

The seminar was closed on Wednesday by a very informative panel who discussed state input, Brexit and the global tax environment relative to Ireland as a market for Biotech manufacturers.

At LSC we understand the importance of sharing industry knowledge and keeping up to date with the latest trends so it was great to attend talks and meet with so many of Ireland’s key Biopharma decision makers at the event.

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