Main Conference: 29-30 April 2027 | Hamburg, Germany
CMC Strategy & Manufacturing Performance
Bridging Regulatory Strategy, Technical Risk, and Commercial Manufacturing Excellence
Align technical CMC development with business milestones, regulatory expectations, and global supply chain resilience.
The CMC Strategy & Manufacturing Performance Track at BioProcess International Europe 2027 brings together VP-level CMC leaders, regulatory strategists, and technical operations directors to de-risk late-stage filings, streamline global tech transfer, and optimise commercial manufacturing.
Go Beyond Theory on CMC
BioProcess International Europe 2027 returns to Hamburg with a new 2-day program designed to elevate CMC from a purely technical execution exercise into a high-level strategic driver of commercial success.
As biopharma pipelines embrace complex modalities such as ADCs, radiotherapies, and viral vectors, regulatory frameworks and supply chains face unprecedented scrutiny. Based on industry feedback, the 2027 program balances technical analytics with critical executive decision-making. This track delivers actionable case studies on navigating accelerated IND/BLA pathways, establishing holistic control strategies, executing global CDMO oversight, and modernising legacy facilities without triggering validation backlogs. Learn how industry leaders are implementing Multi-Attribute Methods (MAM), validating predictive AI under the EU AI Act, and deploying workforce physics to ensure global operational compliance.
Track Themes: A Blueprint for CMC Compliance
Phase-Appropriate CMC & Accelerated Filings
Accelerated Approval Pathways: Structure regulatory packages for accelerated IND/BLA approvals across ADCs, radiotherapies, and novel formats.
Phase-Appropriate Roadmap: Define minimum required data packages for early clinical entry while de-risking long-term stability and manufacturability bottlenecks.
Global Tech Transfer & CDMO Oversight
Strategic CDMO Management: Align control strategies, data sharing, and quality oversight across contract manufacturing and multi-site networks.
Workforce Physics & Operational Flow: Apply workforce modelling and shop-floor physics to optimise human capacity, shift handoffs, and task variance during tech transfer
Post-Approval Modernization & Compliance
Lifecycle Management (ICH Q12): Streamline post-approval change controls and replace legacy infrastructure without causing re-validation backlogs.
AI Regulation & GAMP 5: Establish validation frameworks for non-deterministic software and predictive digital tools under GAMP 5 and the EU AI Act.
Next-Gen Analytics & Comparability
Multi-Attribute Methods (MAM): Implement MAM for routine release testing and accelerate comparability assessments during major process changes.
Global License Filings: Compile robust technical data packages and analytical impurity profiles that satisfy evolving FDA and EMA expectations.
Explore the full CMC Strategy & Manufacturing Performance agenda
CMC Strategy & Manufacturing Performance: Q&A
How does the 2027 CMC track balance technical analytics with strategic leadership?
In response to advisory board feedback, the 2027 track expands beyond technical assay development to focus on strategic leadership drivers. Key sessions address accelerated IND/BLA filing strategies, holistic control strategy development, CDMO relationship governance, and late-stage commercialisation lessons.
What coverage is provided for post-approval changes and facility modernization?
Sessions explore practical applications of regulatory lifecycle management tools like ICH Q12. Speakers will share frameworks for replacing legacy equipment with single-use or intensified systems while avoiding re-validation backlogs and regulatory delays.
How does the track address artificial intelligence and digital tool regulation?
A dedicated session focuses on navigating GAMP 5 and the newly active EU AI Act. Attendees will examine validation frameworks for predictive algorithms and machine learning in GMP environments, adapting quality change controls for non-deterministic software.