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Key Sessions

Stefanos Grammatikos

Keynote: Bioprocess Innovations in the Era of Acceleration and Intensification

UCB Pharma

07:30 - 08:20 50 mins
Registration and Morning Coffee
08:20 - 08:30 10 mins
Chairperson’s Opening remarks
  • Miriam Monge - Director of Marketing Integrated Bioprocess Solutions, Sartorius Stedim FMT S.A.S
08:30 - 09:00 30 mins
BPI Opening Plenary
Keynote: Bioprocess Innovations in the Era of Acceleration and Intensification
  • Stefanos Grammatikos - VP - Head of Biotech Sciences, UCB Pharma
09:00 - 09:30 30 mins
BPI Opening Plenary
Plenary Talk Two – Pall
09:30 - 10:00 30 mins
BPI Opening Plenary
Keynote
  • Christian Eckermann - Site Head Biopharma Austria, Boehringer Ingelheim RCV GmbH & CoKG, Austria
10:00 - 10:30 30 mins
BPI Opening Plenary
Plenary Talk 4 – GE
10:30 - 11:30 60 mins
Morning Coffee and Networking
11:30 - 12:00 30 mins
Info
Manufacturing Technologies – Industry 4.0, Bioprocess Tools and Cost of Goods Considerations
Neoantigen-based personalized cancer vaccines: the promise is enormous but so is the cost that at current levels could bankrupt even developed nations’ economies
  • Dan Adams - Co-Founder and Executive Chairman, NextWaveBio

This session will be address recent results and efforts to make these vaccines affordable.

12:00 - 12:30 30 mins
Manufacturing Technologies – Industry 4.0, Bioprocess Tools and Cost of Goods Considerations
Challenges in Multicomponent Vaccine Development and Manufacturing
  • Krishna Prasad, Ph.D. - Director, Vaccine Development, TBC
12:30 - 13:00 30 mins
Info
Manufacturing Technologies – Industry 4.0, Bioprocess Tools and Cost of Goods Considerations
Purity analysis of gene therapy vectors from process development to commercial process
  • Josefina Nilsson - Head of EM Services, Vironova

Transmission electron microscopy (TEM) can provide unique insights in the characterization of viral gene delivery platforms

such as AAV or lentivirus. Process development decisions can be speeded up by confirming purity and critical quality attributes. This case study shows how undesired sample characteristics such as:

  • Aggregates
  • Host cell debris and residual DNA
  • Loss of capsid integrity


Easily can be identified and quantified by using automated TEM based image analysis software solutions

13:00 - 14:15 75 mins
Lunch in the Exhibition Hall and Live Labs
14:15 - 14:45 30 mins
Continuous Applications in Vaccine Development
Vaccine Development- Optimizing Purification Processes
  • Carsten Voss - Process Chromatography Application Manager, Bio-Rad Laboratories GmbH
14:45 - 15:15 30 mins
Info
Continuous Applications in Vaccine Development
Improving downstream processing of vaccines and gene therapy vectors with continuous chromatography
  • Manuel Carrondo - Professor of Chemical and Biochemical Engineering, FCT-UNL Vice-President,, iBET Portugal
  • Case study
15:15 - 15:45 30 mins
Continuous Applications in Vaccine Development
Spotlight Presentation - GE
15:45 - 16:15 30 mins
Afternoon Coffee Break
16:15 - 16:45 30 mins
Facilities of the Future
Efforts on the development and licensure of an Ebola vaccine
  • Parimal Desai - Vice President, Global Vaccines and Biologics Commercialization, Merck Manufacturing Division, USA
17:15 - 17:20 5 mins
Plenary Changeover
17:20 - 17:50 30 mins
Info
Enhanced biocompatibility, integrity and assurance of quality supply of single use solutions in vaccine manufacturing
  • Jean-Marc Cappia - Group Vice President Marketing & Product Management, Sartorius Stedim Biotech

Key objectives:

The presentation provides an overview of the challenges associated with the increasing adoption of single-use systems (SUS) in vaccines manufacturing and outlines a supply chain and quality strategy where raw material specifications and end to end process controls achieve more consistent biocompatibility, integrity and assurance of quality supply of single use solutions in vaccine manufacturing.

Bas du formulaire


Abstract

Vaccines manufacturing processes are diverse and complex and require strong commitment to quality for every raw materials and process equipment. With single becoming mainstream technology in commercial manufacture of modern vaccines, there is an increasing reliance on supplier quality and growing regulatory and industry requirement for more transparency on supplier’s quality system and supply chain. Single use suppliers are expected to better characterize their materials and processes, control the variability, understand the impact on vaccine quality and continuously improve their quality systems.

The presentation introduces an integrated supply chain and quality by design strategy whereby SUS integrators partner with polymer and film suppliers to combine material science, film extrusion and bag making expertise. These collaborations help optimize the resins and films and provide better knowledge, specifications and controls of the entire manufacturing process. This in turns allows an in depth characterization and control of extractable substances and particles profiles.

The presentation outlines how establishing resin specifications, film extrusion design spaces and quality agreements can significantly reduce raw material variability, provide consistent biocompatibility and improve product robustness and integrity. End to end process control also enhances assurance of supply and change control.



Audience take-home messages:

  • Resin specification and film design space reduce material variability and improve product quality
  • Control of raw materials and processes enhances single use product biocompatibility & integrity
  • End to end process control also improves assurance of supply and change control for single use products
17:50 - 18:20 30 mins
Info
Industry 4.0 in Aviation – Digitalization without beta versions
  • Sven Taubert - Head of Corporate Foresight & Market Intelligence, Lufthansa Technik AG

Topics like Digitalization and Industry 4.0 are currently on everyone's minds. New economy companies revolutionizing more and more classical business models. Aviation, like other safety sensitive industries, is working hard to keep up. Unlike services from the big role models out of e.g. Silicon Valley, aerospace products cannot and will not shipped in Beta status. This presentation will show examples how Lufthansa is addressing these challenges.

18:20 - 19:50 90 mins
Networking Drinks and Evening Social Event
07:30 - 08:20

Registration and Morning Coffee

More
08:20 - 08:30

Chairperson’s Opening remarks

  • Miriam Monge - Director of Marketing Integrated Bioprocess Solutions, Sartorius Stedim FMT S.A.S
More
Showing of Streams
10:30 - 11:30

Morning Coffee and Networking

More
Showing of Streams
13:00 - 14:15

Lunch in the Exhibition Hall and Live Labs

More
Showing of Streams
15:45 - 16:15

Afternoon Coffee Break

More
Showing of Streams
17:15 - 17:20
Plenary Changeover

Plenary Changeover

More
17:20 - 17:50
Info

Enhanced biocompatibility, integrity and assurance of quality supply of single use solutions in vaccine manufacturing

Key objectives:

The presentation provides an overview of the challenges associated with the increasing adoption of single-use systems (SUS) in vaccines manufacturing and outlines a supply chain and quality strategy where raw material specifications and end to end process controls achieve more consistent biocompatibility, integrity and assurance of quality supply of single use solutions in vaccine manufacturing.

Bas du formulaire


Abstract

Vaccines manufacturing processes are diverse and complex and require strong commitment to quality for every raw materials and process equipment. With single becoming mainstream technology in commercial manufacture of modern vaccines, there is an increasing reliance on supplier quality and growing regulatory and industry requirement for more transparency on supplier’s quality system and supply chain. Single use suppliers are expected to better characterize their materials and processes, control the variability, understand the impact on vaccine quality and continuously improve their quality systems.

The presentation introduces an integrated supply chain and quality by design strategy whereby SUS integrators partner with polymer and film suppliers to combine material science, film extrusion and bag making expertise. These collaborations help optimize the resins and films and provide better knowledge, specifications and controls of the entire manufacturing process. This in turns allows an in depth characterization and control of extractable substances and particles profiles.

The presentation outlines how establishing resin specifications, film extrusion design spaces and quality agreements can significantly reduce raw material variability, provide consistent biocompatibility and improve product robustness and integrity. End to end process control also enhances assurance of supply and change control.



Audience take-home messages:

  • Resin specification and film design space reduce material variability and improve product quality
  • Control of raw materials and processes enhances single use product biocompatibility & integrity
  • End to end process control also improves assurance of supply and change control for single use products
  • Jean-Marc Cappia - Group Vice President Marketing & Product Management, Sartorius Stedim Biotech
More
17:50 - 18:20
Info

Industry 4.0 in Aviation – Digitalization without beta versions

Topics like Digitalization and Industry 4.0 are currently on everyone's minds. New economy companies revolutionizing more and more classical business models. Aviation, like other safety sensitive industries, is working hard to keep up. Unlike services from the big role models out of e.g. Silicon Valley, aerospace products cannot and will not shipped in Beta status. This presentation will show examples how Lufthansa is addressing these challenges.

  • Sven Taubert - Head of Corporate Foresight & Market Intelligence, Lufthansa Technik AG
More
18:20 - 19:50

Networking Drinks and Evening Social Event

More