Training-Seminars

Cambridge Healthtech Institute Training Seminars offer real-life case studies, problems encountered and solutions applied, along with extensive coverage of the academic theory and background. Each Training Seminar offers a mix of formal lecture and interactive discussions and activities to maximize the learning experience. These Training Seminars are led by experienced instructors who will focus on content applicable to your current research and provide important guidance for those new to their fields. 

Training Seminars Will Be Held In Person Only
To ensure a cohesive and focused learning environment, moving
between conference sessions and the training seminars is not allowed.





Training Seminars

Monday, January 18, 2027 8:30 AM – 5:00 PM

TS3A: Developability Prediction, Analysis & Mitigation for Biologics

The transition of a therapeutic candidate from early discovery to successful Investigational New Drug (IND) filing represents a critical bottleneck in biopharmaceutical development. High biological potency in a discovery assay means very little if the underlying molecule suffers from structural liabilities that lead to severe aggregation, high viscosity, or chemical degradation during scale-up. Selecting a candidate based solely on efficacy, without an objective evaluation of its manufacturing and quality profile, introduces immense financial and timeline risk during late-stage development. This intensive course provides an applied framework for managing the transition of complex biologics from discovery to CMC. Combining computational triage with material-gated biophysical screening and forced degradation, attendees will learn to systematically identify, score, and remediate structural and physical liabilities. Through anonymized industrial case studies and a mock selection simulation, you will gain practical, multi-parameter optimization strategies to de-risk candidate selection and confidently defend pipelines against late-stage manufacturing failures.
Developability Prediction, Analysis & Mitigation for Biologics
Mauro Acchione, PhD, Director, R&D, Bioprocess Engineering, National Research Council Canada

  • Foundations of Developability, Manufacturability, and Regulatory Strategy Alignment
  • In Silico Sequence Profiling and AI/ML Risk Prediction Tools
  • Comprehensive Biophysical and Analytical Characterization Methodologies
  • Forced Degradation Stress Testing and High-Throughput Formulation Screening
  • High-Concentration Biologics, Viscosity Reduction, and Subcutaneous Delivery
  • Integrated Manufacturability Assessment Across Upstream, Downstream, and Fill-Finish
  • Developability Risk Profiling for Bispecifics, ADCs, and Engineered Scaffolds
  • Mitigation Strategies via Sequence Engineering, Process Optimization, and Formulation
  • Implementation, Cross-Functional Alignment, and Stage-Gate Candidate Risk Management

INSTRUCTOR BIOGRAPHY:

Photo of Mauro Acchione, PhD, Director, R&D, Bioprocess Engineering, National Research Council Canada
Mauro Acchione, PhD, Director, R&D, Bioprocess Engineering, National Research Council Canada
Dr. Mauro Acchione is Acting Director, R&D – Bioprocess Engineering at the National Research Council of Canada's Human Health Therapeutics Research Centre, with over 20 years experience as a senior scientist and people leader supporting discovery and pre-clinical development of complex biotherapeutics. He leads a department of multidisciplinary teams spanning Upstream and Downstream bioprocess development, analytical characterization, cell-line and vector engineering, and process analytical technologies (PAT), advancing biologics and emerging modalities including antibodies, ADCs, viral vectors, cell therapies, and vaccines. He is passionate about advancing PAT and data-driven strategies that build process understanding early rather than retrofitting control later, and he is deeply committed to developing people and fostering collaborative, multidisciplinary teams