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Closed systems in a CNC space – BioPhorum’s closure analysis risk assessment

Analysis and insights into Annex 1 from BioPhorum member companies

Industry leaders unite to advance clinical safety risk assessment for host cell proteins

Best practices and strategic rationale for -40°C drug substance storage-BioPhorum

Your trusted partner in uncertain times

In uncertain times it’s more important than ever to be able to rely on a trusted partner. Because of our independence and collaborative expertise, BioPhorum is valued as safe space for the global biopharma industry.

Upcoming Webinars

Navigating biocompatibility challenges in combination product

15:00-16:30 BST, 29 September 2025

This webinar brings together leading voices from AbbVie, NAMSA, and Takeda to explore the evolving landscape of biocompatibility standards and their impact on device design and compliance.

For more information and to register click here.

BioPhorum best practice on the interchangeability of single-use components

15:00-16:30 BST, 30 September 2025

Introduction to an industry-aligned best practice guidance for evaluating and qualifying the interchangeability of SUCs in single-use assemblies from both supplier and end-user perspectives.

For more information and to register click here.

Particle control strategy for cell therapy products

16:00-17:00 BST, 7 October 2025

In this webinar we will discuss a holistic approach to developing a comprehensive particulate control strategy for CT’s with focus on particle characterization, detection (visual inspection and operator training/qualification) and manufacturing controls with the goal to better understand sources and types of particulate matter, options for control to reduce particle prevalence, and consideration of patient safety.

For more information and to register click here.

Conferences

BioProcess International 2025

15-18 September 
Hynes Convention Center, Boston, USA

From cell line and cell culture to downstream and next generation manufacturing - Join the engineers, scientists and biotech leaders who are fostering scientific innovation to solve today's challenges.

Confirmed BioPhorum speakers include:

• Joanna Rucker Pezzini, PAK Biosolutions,  Unveiling the bioprocess revolution – navigating the path to autonomous control
• Parag Kumthekar, UCB Pharma, Mastering hcDNA: a harmonized CMC approach in AAV therapies.  
• Moira Lynch, ThermoFisher Scientific Aggregates PoC: Adaptive automated cation exchange pooling based on real-time process analytical technology (PAT) monitoring for aggregates
• Rick Morris, Cytiva and Britta Hoeshele, Boehringher Ingleheim  The future of manufacturing operations
• Taylor Chartier, Modicus Prime Implementing AI systems in regulated pharma environments
• Shankar Swaminathan of Astellas Visible particles within cell therapies

Pharma MES - Digital Transformation - Manufacturing Execution

22-25 September 2025
Berlin, Germany

BioPhorum IT Digital and Data is hosting a 'Are we really ready for MES of the future?' workshop on 22 September, between 16:30-17:30 CEST.

This interactive session, hosted by our 'MES of the Future' workstream will be facilitated by:

• Olivia Gannon, Associate Director, Automation (Lonza)
• Philip Hamm, Global Program Manager and Solutions Architect, MES (Merck KGaA Pharmaceutical)
• Ciera Clayton, Global Change Facilitator (BioPhorum)

The workshop will explore readiness for MES transformation, focusing on areas such as:

• How to assess digital maturity and foundational capabilities
• What “ready” really looks like for MES adoption
• Internal barriers- cultural, structural and strategic
• Building a business case for MES strategy

Get in touch

We hope you enjoyed this edition of the BioPhorum newsletter.

If you would like to get in touch or have any comments, please contact the team at hello@biophorum.com