ISPE Europe's Biotech Portfolio

The biotechnology sector is changing the pharmaceutical manufacturing environment: The trend toward personalized medicine is driving smaller batch sizes with higher production volumes. Digitization and integration of GXP computerized systems will leverage data and turn it into predictive control and knowledge. Highly potent products like cancer vaccines and antibody drug conjugates (ADCs) promise enormous potential, but are highly toxic, and require both product and operator protection.

As part of its global strategy, ISPE has pledged to boost its biotech capabilities. The Biotechnology Community of Practice (CoP), established in 2005, is one of 16 offered by the organization. The seven-member Biotechnology Strategy Steering Committee, chaired by Britt Petty and Co-Chaired by Andrew Skibo, was established in 2015 as part of the ISPE strategic plan for 2016–2019.

Biotechnology In Europe Sig

In late 2015, adhering to its global strategy and coordinating closely with the Biotechnology Strategy Steering Committee, Biotechnology CoP, and European Affiliates, ISPE established the Biotechnology in Europe Special Interest Group (SIG) to help ISPE build capabilities and identify areas of opportunity in the European biotechnology manufacturing space (see sidebar).

The group’s vision is to:

• Deliver solutions with tangible results and practical application to the European biopharmaceutical industry
• Increase patient access to medications and make biologics more affordable
• Foster global connectivity between biotechnology industry leaders, experts, and regulators
• Share, present, and document industry solutions to benefit ISPE Affiliates and their stakeholders
• Facilitate disruptive and incremental innovation in biologics development and manufacturing

The SIG identifies European areas of focus and works within the CoP to foster development of technical content and greater networking of biotech professionals in Europe. The SIG Chair coordinates closely with the CoP Chair.

Working groups

The SIG comprises four working groups:

Quality and Regulatory evaluates the effect of new regulation on operations: investment, cost of goods, and special expertise required for regulatory and quality management activities.

Process Science follows the new holistic production control strategy for biological products, the impact of Industry 4.0 and digitalization on biopharmaceutical production, and how computerized process simulation and modeling can shorten time to market.

Innovation explores new developments in platform technologies such as single-use technology, robotics, and 3D printing and how they can best be used in pharma.

Knowledge Management focuses on classifying product-related knowledge transfer, the workforce of the future, the education profile that will be required, capabilities and skillset needed on various levels of production, and quality management in future biotech production.

Biotechnology in Europe SIG Members

• Chair Michelangelo Canzoneri, Head of Technology and Innovation, Therapeutic Proteins, Sanofi, Germany, and Chair of the Europe Biotech SIG
• Tom Bannon, Senior Process Engineer, PM Group, Ireland
• Angelo Bernardis, Global Pharma Technology Manager, Amec Foster Wheeler, Italy
• Andrew Brown, Allergan (formerly Actavis Biologics), Liverpool, UK: Manager, Downstream Process Development and Process Engineering
• Richard Denk, Head Sales Containment, SKAN AG, Switzerland
• Ylva Ek, Qualification Program Manager, Enterprise Solutions, GE Healthcare; Vice Chair of the ISPE Nordic Affiliate; member of the ISPE Biotechnology SIG and the EMEA Regulatory and Compliance Committee
• David Estapé, PhD, Technology Manager, Global Life Sciences and Chemicals Business Unit, M+W Group, Germany
• Niels Guldager, CPIP, Global Technology Partner, Biotech, NNE, Denmark
• Christoph Herwig, Professor of biochemical engineering at the Vienna University of Technology, Austria
• Eamon Judge, European Project Planning Leader, Global Facilities Delivery, Eli Lilly and Company, Ireland, and President of the ISPE Ireland Affiliate
• Ralf Kretzschmar, Liquid Processing Equipment, Bioprocessing Equipment and water preparation systems, Bosch Pharma
• René Labatut, Vice President, Global Head of Technology Innovation, Sanofi Pasteur, France
• John Milne, Training Director at the National Institute for Bioprocessing Research and Training, Ireland
• Miriam Monge, Director of Process Development Consultant Team, Director of Marketing Integrated Solutions, Sartorius Stedim, France
• Frank Nygaard, CMC Project Director, Symphogen, Denmark
• Kevin Page, PhD, Senior Good Manufacturing and Distribution Practice Inspector, MHRA, UK
• Johanne Piriou, Expert Consultant, Aktehom, France
• Annette Peceny, PhD, Senior Director CustomBiotech–BioPharma, Roche Diagnostics GmbH, Germany
• Patrick Sagmeister, Co-founder and CTO, Exputec, Austria
• Manfred Seifert, Head of Sales, Western Europe, Zeta Biopharma GmbH, Austria
• Christian Wölbeling, Senior Director Global Accounts at Werum IT Solutions, Co-Chair of ISPE’s Knowledge Network Council and GAMP MES SIG; member of the Pharma 4.0 SIG, Pharmaceutical Engineering Committee, and DACH Affiliate Board
• Thomas Zimmer, ISPE Vice President of European Operations, Germany

ISPE Europe Biotechnology

In the past two years, ISPE Europe has come to the forefront of the organization’s effort to deliver solutions with tangible results and practical application for the biopharmaceutical industry. As part of its effort to connect biotechnology leaders, experts, and regulators, ISPE Europe hosted its first Conference on Biotechnology, “Reinventing Commercial Biomanufacturing,” in Frankfurt, Germany, 24–25 October 2016. Pharmaceutical Engineering presented highlights of the event in the January-February 2017 issue.

Dublin 2017

The 2017 Europe Conference on Biotechnology “Biotechnology Factories of the Future” will be held in Dublin, Ireland, 26–27 September. The conference will explore capacity constraints, innovative tools in knowledge management, process science, technological advancement, and future challenges in the biotechnology industry.

Keynote speaker Gerald Kierans, Director of Technical Services, Pfizer Pharmaceuticals, Grange Castle, Ireland, will address the capacity situation of contract manufacturing organizations (CMOs), contract research organizations, and analytical laboratories; the demand for key discipline expertise as the biotechnology industry expands and diversifies; and the technology platforms and product portfolios that may experience bottlenecks.

Dominic Carolan, CEO, National Institute for Bioprocessing Research and Training, Dublin, will address the human factor in this landscape: How should we train and educate people?

Richard Parker, Senior GMDP Inspector, Medicines and Healthcare Products Regulatory Agency (MHRA), UK, will provide insight into regulatory development for biopharmaceuticals.

Bjoern Philipp Kloke, Head of IVAC Technology Platform Engineering, and Martin Zindler, Software Architect, both at BioNTech AG, Frankfurt, will speak about individualized medicines in biologics.

Track 1: Technology, innovation, and factory of the future

Industry case studies will illustrate megatrends influencing new pharmaceutical plant construction:

• Biologics manufacturing “Industry 4.0”: full automation, the elimination of human beings from the shop floor and movement of qualified people to production control strategies, process control, and quality oversight.
• Product portfolios will become more heavily weighted with biologicals, fusion proteins, and ADCs; originator products will be replaced with biosimilars and personalized medicine.
• Smaller batches and more complex product portfolios will increase the use of single-use technology to avoid lengthy cleaning validation and cleaning processes.
• Technology platforms will include active substances with higher toxicities that require full containment in manufacturing processes and open product handling.
• Continuous manufacturing will reduce time to market by excluding scale-up processes and related risks. Upstream and downstream technology platforms will benefit.

The track will include a panel discussion on Ireland as a market for biotech manufacturers and how Brexit could influence the production landscape.

Track 2: Process science, knowledge management, and regulatory

Topics will include enablers such as data science workflows to realize new production control strategies, using diagnostic tools for process control in biologics production, and new ways to characterize extractables and leachables. Other sessions will explore quality management in this new environment, as well as the capabilities, skill sets, and education needed to establish the workforce of the future. Track 2 will also feature a panel discussion on regulatory challenges in biologics production.

For more information on the Biotechnology in Europe SIG, CoP, or Steering Committee, contact Michelangelo.Canzoneri@sanofi.com.