Antibody Engineering Training Program

Master end-to-end antibody engineering workflows from discovery to validation and translation. Start with online fundamentals, then progress through practical modules covering discovery, expression, purification, biophysical and functional analytics, optimization, and tech transfer.

Module 1 – Fundamentals of Antibody Engineering (Theory - Online)

1. Immunoglobulin architecture (Fab/Fc) , paratope–epitope concepts, isotypes & subclasses.
2. Antigen strategy: peptide vs protein, carrier conjugation, adjuvant overview.
3. Discovery routes: polyclonal, hybridoma, phage/yeast display, synthetic libraries.
4. Antibody formats: scFv, Fab, full IgG, Fc‑fusions, bispecifics, nanobodies.
5. Epitope types (linear vs conformational) ; affinity vs avidity.
6. Developability: stability, aggregation, viscosity, PTMs, glycosylation concerns.
7. Immunogenicity risk basics; humanization concepts.
8. Analytics landscape: ELISA, Western, flow, SPR/BLI, DSF, DLS, SEC.
9. Quality frameworks: GLP/GMP touchpoints, documentation mindset.
10. IP & FTO orientation; data integrity (ALCOA+) basics.

Module 2 – Lab-Scale Discovery: Hybridoma/Display & Primary Screening (Practical)

1. Antigen preparation & QC: SDS‑PAGE, endotoxin check, concentration & storage.
2. Plate coating optimization: pH, buffer, surface, blocking selection.
3. Hybridoma demo: fusion overview, HAT selection, clone picking, stability checks.
4. Phage display: input library handling, 3× biopanning, washing stringency.
5. Titration of output phage; amplification workflow overview.
6. Primary ELISA screening; cutoff setting; hit triage rules.
7. Specificity profiling vs close homologs; counter‑selection concept.
8. Epitope binning by competitive ELISA (pairwise matrix) .
9. Sanger/NGS capture of VH/VL from selected hits (workflow) .
10. Data capture templates; preliminary ranking dashboard.

Module 3 – Recombinant Expression & Purification (Practical)

1. Vector design: signal peptides, tags, promoters; cloning strategy for VH/VL.
2. Gibson/Golden‑Gate assembly; colony PCR & sequence verification.
3. Transient transfection (HEK293/CHO) setup; expression timeline.
4. Harvest & clarification; titer estimation by ELISA/UV280.
5. Protein A/G/L capture parameters; binding, wash, elution optimization.
6. Buffer exchange & concentration (TFF/spin) ; storage buffers.
7. SEC polishing for monomer%; aggregate monitoring.
8. HCP/endotoxin awareness; routine assessment workflow.
9. QC: SDS‑PAGE, Western blot, UV280; yield & purity reporting.
10. Stability hold studies (short‑term) and stock management.

Module 4 – Biophysical & Functional Characterization (Practical)

1. SPR/BLI method design; ligand immobilization vs analyte; regeneration strategy.
2. Kinetic analysis: kon, koff, KD extraction; model fit checks.
3. Epitope mapping/binning using sandwich BLI matrix.
4. Thermal stability by DSF; Tm comparison across variants.
5. DLS for hydrodynamic size; SEC for aggregation profiling.
6. Isoelectric focusing/CIEX overview for charge variants.
7. Flow binding to cell‑expressed target (workflow overview) .
8. Neutralization assay design for ligand–receptor blockade models.
9. Data QC, repeatability and basic acceptance criteria.
10. Reporting templates for tech reviews.

Module 5 – Assay Development & Diagnostic Applications (Practical)

1. Sandwich ELISA: capture/detector pairing; checkerboard optimization.
2. Standard curve design; LOD/LOQ & linearity assessment.
3. Precision (intra/inter) & accuracy (recovery) studies.
4. Interference/matrix effects; hook effect checks.
5. LFA prototyping: conjugation basics, membrane selection, run profiles.
6. Stability indicating buffers & preservatives selection.
7. Accelerated vs real‑time stability outlines.
8. Controls & calibration strategy (IQC/EQC basics) .
9. SOP authoring: method, acceptance criteria, change log.
10. Transfer packet essentials for diagnostics.

Module 6 – Advanced Affinity Maturation & Library Engineering (Practical)

1. Liability scan; CDR targeting strategy (H/L chains) .
2. Error‑prone PCR setup; mutation spectrum & QC.
3. DNA shuffling & combinatorial assembly workflows.
4. Display selections under off‑rate enrichment pressure.
5. pH/temperature challenge during selection for stability bias.
6. High‑throughput ELISA/BLI screening cascade.
7. Sequence–function correlation; clonal consolidation.
8. Lead ranking by potency, specificity & developability signals.
9. Mini‑panel characterization to confirm gains.
10. Iteration planning for next‑round diversification.

Module 7 – Cell‑Based MOA & Effector Function Analytics (Practical)

1. Receptor expression verification; flow panel setup & gating basics.
2. Binding & internalization kinetics (flow‑based outlines) .
3. ADCC surrogate setup; effector:target ratios; readouts.
4. CDC concept & complement source handling.
5. Reporter assays for pathway modulation (e.g., NF‑κB, MAPK) .
6. Neutralization/competition formats; potency metrics.
7. Assay controls, variability sources & mitigation.
8. Data normalization & curve fitting essentials.
9. Safety notes: BSL practices & waste disposal.
10. Result interpretation for go/no‑go decisions.

Module 8 – Developability & Stability Engineering (Practical)

1. Aggregation/viscosity risk assessment; sequence liabilities review.
2. pH/ionic strength/excipient screening matrix design.
3. Glycoform awareness; Fc engineering considerations (overview) .
4. Forced degradation: heat, agitation, light, oxidation.
5. Iso/osmolarity & tonicity considerations for formulation.
6. Hold‑time & freeze‑thaw robustness checks.
7. Container/closure interaction awareness.
8. Stability indicating assays selection.
9. Acceptance criteria & trending basics.
10. Formulation down‑selection & recommendation.

Module 9 – Manufacturing Readiness: Scale‑Up, QC & Documentation (Practical)

1. Upstream scale plan: transfection scale‑up, feeds, harvest outlines.
2. Downstream trains: capture–intermediate–polishing overviews.
3. Release/QC panel: identity, purity, potency, safety (endotoxin/HCP) .
4. In‑process controls & critical process parameters (CPPs) awareness.
5. Batch records & data integrity (ALCOA+) practices.
6. Deviation/CAPA & change control basics.
7. Environmental monitoring awareness.
8. Stability protocol & retest concepts.
9. Equipment qualification & calibration outlines.
10. Tech transfer dossier: methods, specs, acceptance criteria.

Module 10 – Translational & Regulatory Dossier + Capstone (Practical)

1. Clinical orientation: nonclinical packages & immunogenicity risk planning.
2. Regulatory frameworks & dossier structuring (overview) .
3. IP/FTO refresh; claim strategy; publication timing.
4. Quality system alignment: GLP/GMP touchpoints for labs.
5. Risk registry & mitigation planning.
6. Project management cadence & stakeholder reviews.
7. Capstone plan: select target, design assays, execute subset.
8. Data pack assembly: figures, tables, acceptance summaries.
9. Formal presentation & review feedback loop.
10. Career portfolio curation & next‑steps roadmap.