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 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, Senior Scientist and Team Leader, Quality Attributes and Characterization, 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, Senior Scientist and Team Leader, Quality Attributes and Characterization, National Research Council Canada — **Mauro Acchione, PhD, Senior Scientist and Team Leader, Quality Attributes and Characterization, National Research Council Canada**
Mauro Acchione is a Senior Scientist and Team Leader at the National Research Council of Canada (NRC), Human Health Therapeutics Research Centre. He leads a multidisciplinary team specializing in the analytical characterization, developability assessment, and quality evaluation of complex biologics. Over his career, he has directed technical support across a broad spectrum of modalities, including monoclonal and bispecific antibodies, fusion proteins, enzymes, viral vectors (AAV), vaccines, and cell therapies. His teamâ€™s operational scope spans early pre-IND candidate triage through CMC development, regulatory comparability, formulation, stability, and technology transfer. Dr. Acchione has extensive practical experience deploying biophysical and biochemical characterization tools to systematically isolate and mitigate risks related to aggregation, viscosity, polyspecificity, and manufacturabilityâ€”collaborating widely with industry, academic, and government partners.