Peptide Therapeutics CMC: Impurities Management and Control Strategy
30 September 2026
- 01 October 2026
Online Event
Spaces available
Event overview
Course tutors:
Dr Osama Chahrour,
Dr Andrew Teasdale
| BACK BY POPULAR DEMAND |
Peptide therapeutics continue to expand across modalities and indications, yet their Chemistry, Manufacturing and Controls (CMC) present distinctive challenges: complex synthesis routes, diverse impurity profiles (process-, product-, and degradation-related), and evolving regulatory expectations. This course, delivered by Scientific Update, provides a practical, end‑to‑end framework for developing and executing robust impurity management and control strategies for peptide drug substances and drug products. Through a combination of technical lectures, case studies, and interactive exercises, participants will learn how to design phase‑appropriate CMC strategies that accelerate development, reduce risk, and meet global regulatory requirements.
This online course will take place over two live sessions, timings are:
PDT: 5.30am-9.30am | CDT: 7.30am-11.30am | EDT: 8.30am-12.30pm | BST: 1.30pm-5.30pm | CEST: 2.30pm-6.30pm
– Wednesday, September 30th
– Thursday, October 1st
Course Outline
- Foundations of Peptide CMC: Scope, terminology, regulatory context.
- Peptide Synthesis and Process Understanding: Solid‑phase peptide synthesis (SPPS) vs. liquid‑phase; resin/linker choices; coupling/cleavage chemistry; critical process parameters.
- RSM selection: The requirements of ICH Q11 and its associated Q&A in relation to the selection of starting materials as relevant to synthetic peptides.
- Impurity Landscape in Peptides: Product‑related (sequence variants, truncations, deletions/insertions, D‑isomers, racemization, oxidations, deamidation, aggregation), process‑related (reagents, catalysts, protecting group remnants), and degradation products.
- Analytical Strategies and Method Qualification/Validation: LC‑MS/MS, HRMS, CE, HPLC/UPLC, chiral analysis, peptide mapping, release/stability methods; phase‑appropriate validation and system suitability.
- Peptide Characterization: Elucidation of Structure and other Characteristics. How the structure of the peptide should be confirmed by analytical data, this includes the primary, secondary, tertiary and quaternary structure as relevant to regulatory submission.
- Reference standards setup: How to establishes the reference standards in peptides CMC development with the e appropriate precautions against peptide unique risks.
- Establishing an Impurities Control Strategy: Risk assessment, specification setting, reporting/identification/qualification thresholds, limits for known/unknowns, control points across DS/DP.
- Purification and Downstream Controls: Chromatography selection (RP, IEX, HIC), orthogonal purification and pooling IPCs.
- Stability and Degradation Pathways: Forced degradation design, photo/thermal/humidity stress, kinetic profiling, shelf‑life assignment, storage and packaging.
- Specification Setting and Justification: DS/DP specs, setting limits for sequence variants and critical impurities, statistical use of development data, linking specs to clinical risk/benefit.
- Latest EMA Guideline on the Development and Manufacture of Synthetic Peptides, Regulatory Interactions and CMC Documentation: Module 3 content, control strategies in filings, responses to agency queries, global harmonization considerations.
- Case Studies and Workshops: Real‑world scenarios, interactive risk assessment and spec‑setting exercises.
Benefits of Attending
- Practical, phase‑appropriate CMC know‑how: Translate guidelines into actionable development decisions from early research to commercial readiness.
- Robust impurity management: Build defensible strategies for identifying, controlling, and qualifying impurities to reduce program risk.
- Improved analytical and specification setting: Select fit‑for‑purpose methods and justify limits aligned to patient safety and regulatory expectations.
- Stronger regulatory readiness: Prepare clear, coherent CMC packages and respond effectively to agency questions.
- Real‑world problem solving: Learn from case studies and hands‑on exercises to manage OOS/OOT, deviations, and late‑stage surprises.
- Cross‑functional alignment: Bridge process, analytical, QA, and regulatory perspectives to create integrated control strategies.
Who Should Attend
- CMC leaders and project managers working on peptide therapeutics.
- Process chemists/engineers involved in SPPS, purification, and scale‑up.
- Analytical scientists developing and validating peptide methods.
- Quality/QA and QC professionals setting specifications and managing investigations.
- Regulatory affairs specialists preparing Module 3 and engaging with agencies.
- Tech transfer and CDMO managers overseeing outsourced peptide manufacturing.
- R&D scientists transitioning peptide programs from discovery to development.
What’s Included
- Instructor‑led lectures and case studies covering peptide CMC, impurities, and control strategies.
- Interactive workshops and templates for risk assessment, control strategy mapping, and specification drafting.
- Course materials: Slides, checklists, example protocols (e.g., forced degradation), and reference outlines for Module 3 sections. E-reader version included, optional printed copy available for purchase
- Tools and examples: Sample impurity classification matrices, method validation plans, and control strategy frameworks.
- Q&A sessions and discussion: Opportunities to address participants’ specific challenges.
- Certificate of completion acknowledging professional development.
Become a speaker at one of our events
Share your expertise with a global audience of industry professionals. Scientific Update is continually seeking thought leaders and industry innovators to speak at our renowned conferences and training courses.
Peptide Therapeutics CMC: Impurities Management and Control Strategy
30 September 2026
- 01 October 2026
Online Event