5 modules available individually or as a package

Module 1: Design and Engineering of Therapeutic Antibodies (3h30)
Objective: Understand strategies for generation, optimization, and selection of the right candidate

Content:

• Structural reminders and mechanisms of action

• Generation platforms (hybridomas, phage display, single B-cell, etc.)

• Defining the TPP (Target Product Profile)

• Developability criteria: affinity, specificity, solubility

• Engineering: humanization, Fc engineering, immunogenicity

• In silico tools and biophysical tests

Expert: Alexandre FONTAYNE

Module 2: Functional Analyses and Lead Candidate Selection (3h30)
Objective: Master in vitro evaluation methods and selection criteria to move forward to production

Content:

• Functional methods: binding, neutralization, ADCC, CDC

• Comparative analyses of candidate clones

• Correlation with in vivo mechanisms of action

• Lead decision-making: trade-offs, “go/no-go” criteria

• Case study: choosing an antibody among 3 candidates

Expert: Alexandre FONTAYNE

Module 3: Preclinical Development of Antibodies
Objective: Gain a comprehensive understanding of preclinical development of antibodies and ADCs, integrating their pharmacological specificities

Content:

• Pharmacodynamics: characteristics of antibodies and ADCs, production, mechanism of action, indications

• Pharmacokinetics: ADME principles, antibody-specific features, affinity, biodistribution, impact factors, immunogenicity

• Proof of concept: target selection, in vitro/in vivo studies, animal models, validation

• Tegenero case study: FIH risk management, MABEL/NOAEL approaches, limitations of animal models

Expert: Jacques GOUTALIER

Module 4: Process Development and Analytical Strategy (CMC) (3h30)
Objective: Understand the fundamentals of CMC development to secure clinical entry

Content:

• Cell line development (CHO, HEK…), cell banks

• Upstream & downstream: critical steps, yield & purity

• CQAs (Critical Quality Attributes) and in-process controls

• Analytical methods: HPLC, ELISA, CE-SDS, icIEF, bioassays…

• Basics of CMC strategy and regulatory requirements (ICH Q6B)

Expert: René LABATUT

Module 5: Technology Transfer and Clinical Manufacturing Strategy (3h30)
Objective: Prepare a smooth and compliant technology transfer to a CDMO or in-house production unit

Content:

• Definition of technology transfer (TT) and its challenges

• Transfer dossier: content, structure, level of detail

• Transfer to a CDMO: roles, responsibilities, key steps

• Technical communication, deviation management, mitigation plan

• Quality requirements and documentation

• Case studies: success factors and common pitfalls to avoid

Expert: René LABATUT