Cambridge Healthtech Institute’s 12th Annual
Intensified & Continuous Bioprocessing
From Pilot to GMP: Making Continuous Mainstream
June 16-17, 2027
Industry adoption of continuous biomanufacturing is accelerating, bringing new regulatory, control and operational challenges. The Intensified & Continuous Bioprocessing conference brings together process development, MSAT and CMC scientists to address the full scope of implementation challenges, from applying ICH Q13 and showing batch-to-continuous comparability, to intensified manufacturing of bispecifics, ADCs and high-concentration drug substance. Sessions will also highlight advances in PAT and real-time control, tech transfer, and building supply chain resilience for intensified processes. Attendees will come away with a clearer route from development data to a filed, inspection-ready continuous process.
Coverage will include, but is not limited to:
- THE REGULATORY & CMC PLAYBOOK FOR CONTINUOUS BIOLOGICS
- Applying ICH Q13 to therapeutic proteins
- Navigating the FDA AMT Designation Pathway
- Establishing batch-to-continuous comparability
- Process characterization strategy transitioning from batch to continuous processing
- Validating viral clearance in continuous processes
- Regulatory perspective on AI/ML and digital twin applications
- Scaling up intensified fed-batch vs. regular fed-batch—facility fit and CMO adaptation
- INTENSIFIED PROCESSING FOR COMPLEX ANTIBODY, VIRAL VECTORS & NOVEL PROTEIN FORMATS
- Perfusion manufacturing of bispecific antibodies
- Multicolumn chromatography for complex formats
- Continuous conjugation approaches for ADC manufacturing
- Comparation of fed-batch flow and continuous downstream process designs
- Addressing/controlling quality attribute drifts during continuous production
- CONTINUOUS, INTENSIFIED & CONNECTED DOWNSTREAM PROCESSING
- More efficient ProteinA utilization
- Multi-column periodic counter-current capture chromatography
- Continuous low-pH viral inactivation bioreactor design
- Integrated flow-through polishing with inline virus filtration
- Non-affinity/alternative capture, continuous capture and rapid cycling chromatography
- Online multi-parameter PAT (e.g., APIES) for viral inactivation monitoring
- HIGH-CONCENTRATION SUBCUTANEOUS DRUG SUBSTANCE & CONNECTED IN-LINE FORMULATION
- Single-pass concentration to high-concentration drug substance
- Connected in-line diafiltration monitoring for formulation
- Modeling of buffer exchange or diafiltration for high concentration formulation
- Viscosity-reducing strategies for subcutaneous antibodies
- ENSURING ROBUSTNESS FROM DEVELOPMENT TO MANUFACTURING
- Equipment/model validation and tech transfer into GMP environments
- Qualifying scale-down models for perfusion, intensified fed-batch
- Converting a legacy process to new processes for commercial programs
- Derisking tech transfer—cross-site and cross-scale model transferability
- Statistical equivalence testing for tech transfer
- Design commercial process that can handle both low and high intensified processes
- Hybrid facilities combining stainless steel and single-use
- PAT, PROCESS MODELING & CONTROL
- In-line RAMAN and dialectric spectroscopy advancements for feedback-controlled feeding
- Real-time estimation of process states, quality testing, release testing
- Soft advanced biosensors for real-time CQA estimation
- One-step automation—fully autonomous process from up- to down-stream to QC
- PAT in GMP manufacturing—implementation and how it shapes regulatory submissions
- SUPPLY CHAIN RESILIENCE FOR INTENSIFIED PROCESSES
- Standardizing consumables for supply resilience
- Buffer recycling
- Resin lifetime extension and reuse strategies
- Use of bioeconomy substrates and how to cope with raw material viability
The deadline for priority consideration is November 20, 2026.
All proposals are subject to review by session chairpersons and/or the Scientific Advisory Committee to ensure the overall quality of the conference program. Additionally, as per Cambridge Healthtech Institute’s policy, a select number of vendors and consultants who provide products and services will be offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.
Opportunities for Participation:
- To submit a podium presentation, please click here.
- To become a sponsor, click here.
- To present a poster, click here.
- To sign up to attend, click here.