Main Conference: 29-30 April 2027 | Hamburg, Germany
Advanced & Complex Modalities
From Viral Vectors and Conjugates to Cell Therapies and Extracellular Vesicles
Transition novel biotherapeutics from breakthrough science into robust, industrial-scale reality.
The NEW Advanced & Complex Modalities Track at BioProcess International Europe 2027 brings together leading vector engineers, bioprocess heads, and CGT manufacturing specialists to overcome scale-up bottlenecks, master impurity clearance, and operationalise closed automated systems for next-generation medicine.
Go Beyond Theory for Advanced Modalities
BioProcess International Europe 2027 returns to Hamburg with an expanded 2-day program that broadens the scope of traditional ATMPs to encompass the full spectrum of advanced, non-platform therapeutics.
As the biopharma landscape evolves beyond standard monoclonal antibodies, bioprocess teams face unique biophysical challenges across cell and gene therapies, viral vectors (AAV, LV), antibody-drug conjugates (ADCs), radiotherapies, LNPs, and extracellular vesicles (EVs). This track delivers actionable case studies and technical solutions for large-scale bioreactor transfection, empty/full capsid separation, residual host cell DNA clearance, and stable producer cell line development. Learn how industry leaders are designing closed, gloveless automated suites, establishing standardised upstream/downstream templates for emerging modalities, and aligning with evolving FDA and EMA regulatory guidelines.
Track Themes: A Blueprint for Advanced/Complex Products
Scalable Vector Production
Scale-Up & Transfection: Troubleshoot fluid mixing, hydrodynamics, and N/P ratios during large-scale bioreactor runs using automated single-use fluid-handling designs.
Stable Expression Systems: Evaluate the financial and operational benefits of transitioning to stable producer cell lines over transient transfection.
Vector Recovery & Impurity Clearance
AAV Capsid Separation: Achieve clean separation of full vs. empty AAV capsids using precise pH/salt gradient chromatography across monoliths, membranes, and resins.
Host Cell DNA Clearance: Navigate evolving FDA and EMA specifications, risk-based impurity limits, and harmonised reporting standards informed by BioPhorum workstreams
Conjugates, LNPs & Complex Formats
Design-for-Conjugation: Implement upstream media additives and process controls to steer post-translational quality and lock in consistent Drug-to-Antibody Ratios (DAR).
Low-Shear Filtration: Deploy hollow fibre and single-use TFF loops to prevent structural damage during high-velocity filtration of delicate modalities.
Closed CGT & Future Modalities
Automated Processing: Eliminate high-risk manual interventions by deploying enclosed, automated handling units for cell therapies.
Exosomes & Extracellular Vesicles: Optimise downstream filtration templates and single-vesicle flow cytometry to validate active cargo and purity.
Explore the full Advanced & Complex Modalities Agenda
Advanced & Complex Modalities: Q&A & Expert Insights
Why has this track expanded from ATMPs to Advanced & Complex Modalities?
While cell and gene therapies remain central, biopharma pipelines increasingly integrate hybrid formats such as ADCs, radiotherapies, LNPs, multi-specifics, and exosomes. Broadening the scope allows you to address shared bioprocess bottlenecks. Such as low-shear filtration, complex impurity clearance, and specialised drug-delivery chemistry—in a single dedicated forum.
How can cell and gene therapy developers reduce Cost of Goods (COGS)?
Addressing the "COGS Crisis" requires radical changes in manufacturing strategy, such as optimising the "Make vs. Buy" decision and selecting the right CDMO partnership. Technical solutions include implementing closed, automated systems to reduce labour costs and employing process intensification to drive down the cost per dose for commercial viability.
What is cell-free synthesis for AAV manufacturing?
Cell-free synthesis is an enzymatic system that bypasses living cells entirely to assemble AAV vectors. This technology offers a potential step-change in speed and scalability, producing high-quality vectors in hours rather than weeks and eliminating the biological variability associated with traditional cell-based production.
Why is the transition to closed, automated systems critical for cell therapy?
Automating cell therapy manufacturing (e.g., using robotic isolators) removes human error and ensures sterility, which is essential for regulatory compliance. Closed systems enable the scalable production of both autologous and allogeneic therapies by maintaining a controlled environment from "vein-to-vein" and simplifying the validation of the manufacturing process.
What are the key challenges in LNP manufacturing for in vivo delivery?
Manufacturing Lipid Nanoparticles (LNPs) requires precise control over Critical Process Parameters (CPPs) to ensure consistent particle size and efficient encapsulation of the payload (e.g., mRNA or gene-editing tools). Scaling these processes from the lab to GMP requires robust strategies to maintain particle attributes and stability for effective in vivo delivery.
What coverage is provided for Exosomes and Extracellular Vesicles (EVs)?
Dedicated sessions explore scalable downstream templates for clinical-stage EVs, focusing on cross-flow filtration parameter optimization, host contaminant removal, and advanced analytical tools like single-vesicle flow cytometry to validate active therapeutic cargo.