Topics we develop (excerpt)
SmartFactory Workshop - IOPC Congress Disposables Solutions for Biomanufacturing, Amsterdam
SmartFactory Workshop
A SmartFactory workshop was developed by PHA to allow quick investment and operational cost calculations for a new single-use biopharmaceutical manufacturing facility. Achieve a holistic approach through the design template used in GMP facilities (e.g. for the manufacturing of monoclonal antibody bulk drug substance on a 2 - 6 x2000 L scale).
Based on a pre-workshop questionnaire completed by the attendees, PHA will select a project (product portfolio/model process) and work through the workshop process. Together we will determine the degree that the template facility must be adjusted to best fit the requirements. The first step is to determine the degree that the template facility as designed by PHA must be adjusted to best fit the need of this project. If the project is reasonably similar this workshop yields already preliminary investment cost with +/- 30% accuracy and the related operational cost.
Attend Workshop To:
· Map a product portfolio and process variations to position fundamental quality concepts
· Understand the cost structure of single use operations and explore the advantages and limitations for scale out opportunities
· Develop strategies on how to mitigate risks during project execution and assess the impact on the global manufacturing and supply chain
A SmartFactory workshop was developed by PHA to allow quick investment and operational cost calculations for a new single-use biopharmaceutical manufacturing facility. Achieve a holistic approach through the design template used in GMP facilities (e.g. for the manufacturing of monoclonal antibody bulk drug substance on a 2 - 6 x2000 L scale).
Based on a pre-workshop questionnaire completed by the attendees, PHA will select a project (product portfolio/model process) and work through the workshop process. Together we will determine the degree that the template facility must be adjusted to best fit the requirements. The first step is to determine the degree that the template facility as designed by PHA must be adjusted to best fit the need of this project. If the project is reasonably similar this workshop yields already preliminary investment cost with +/- 30% accuracy and the related operational cost.
Attend Workshop To:
· Map a product portfolio and process variations to position fundamental quality concepts
· Understand the cost structure of single use operations and explore the advantages and limitations for scale out opportunities
· Develop strategies on how to mitigate risks during project execution and assess the impact on the global manufacturing and supply chain
CellWorld, Shanghai
Continous processing: Key decisions during conceptual and basic design.
Year: 2017
Year: 2017
Biotech, Switzerland
Template Facilities for BRIC(K) Countries
*Brazil, Russia, India, China (Korea)
Year: 2016
*Brazil, Russia, India, China (Korea)
Year: 2016
CellWorld, San Franzisco
Factory Sizing: Single-use versus stainless steel
Global Bio-manufacturing Summit, USA
Manufacturing Strategies for BRIC(K) Countries
*Brazil, Russia, India, China (Korea)
Year: 2015
Engineering in Life Sciences
Best practices for successful implementation of single-use technology and qualification.
Year: 2014
Year: 2014
CMO Consulting Summit, Denmark
Biopharmaceutical Perspectives of Outsourcing: What are Supply Chain Management Issues and Opportunities and The Role Consultants Play
Year: 2013
Year: 2013
Biotech, Switzerland
Best Practices: Single-Use Implementation for Manufacture of Antibodies and Antibody Drug Conjugates
Year: 2013
Year: 2013
Single-Use Solutions in BPC, NL
Single-Use Antibody Manufacturing: Plenary speaker
Year: 2011
Year: 2011
Several meetings, Korea
Single-Use Antibody Manufacturing: points to consider when designing a single-use facility
Year: 2010
Several meetings, USA
Pfizer NEWCON: Useful Principles for Biopharmaceutical Manufacturing
Year: 2010
Year: 2010
Rentschler Innovationsforum
Clinical Antibody Manufacturing: A Comparison of Single-Use Implementation to Cleaning Validation Programs
Year: 2009
Year: 2009
WILBIO Europe, Hamburg, D
Clinical Antibody Manufacturing: A Comparison of Single-Use Implementation to Cleaning Validation Programs
Year: JUL 2009
Year: JUL 2009
European Antibody Congress, Lyon, F
Business: the Impact of the European bio-similar Regulation on the Development of new Antibodies
Year: 2006
Year: 2006