Philipp Hess Associates

Biotechnology . Manufacturing . Management

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

CellWorld 2017, Shanghai

Continous processing: Key decisions during conceptual and basic design.
Year: 2017

Biotech 2016, Switzerland

Template Facilities for BRIC(K) Countries
 *Brazil, Russia, India, China (Korea)
Year: 2016

CellWorld 2015, 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
pdf

Engineering in Life Sciences

Best practices for successful implementation of single-use technology and qualification.
Year: 2014

CMO Consulting Summit 2013, Denmark

Biopharmaceutical Perspectives of Outsourcing: What are Supply Chain Management Issues and Opportunities and The Role Consultants Play
Year: 2013

Biotech 2013, Switzerland

Best Practices: Single-Use Implementation for Manufacture of Antibodies and Antibody Drug Conjugates
Year: 2013

Single-Use Solutions in BPC, NL

Single-Use Antibody Manufacturing: Plenary speaker
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

Rentschler Innovationsforum

Clinical Antibody Manufacturing: A Comparison of Single-Use Implementation to Cleaning Validation Programs
Year: 2009

WILBIO Europe 2009, Hamburg, D

Clinical Antibody Manufacturing: A Comparison of Single-Use Implementation to Cleaning Validation Programs
Year: JUL 2009

European Antibody Congress 2006, Lyon, F

Business: the Impact of the European bio-similar Regulation on the Development of new Antibodies
Year: 2006