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We bring together specialists from all key disciplines involved in the lifecycle of biologics, covering CMC Management, including: Analytical Development & Quality Control (QC), Process & Product Development, Quality Assurance (QA) & Regulatory Affairs, Manufacturing, Laboratory Informatics & Data Integrity, and Guidelines & Compliance.
CMC (Chemistry, Manufacturing, and Controls)
- Quality Target Product Profile (QTPP)
- Product specifications
- Patient-centric Pharmaceutical Development
- Personalized Medicine
- Outsourcing
- Biosimilars
- Stability
- Reference standard management
- CMC knowledge management
- Product control strategy
- Critical Quality Attributes (CQAs)
- First in human (FIH)
Analytical Development & Quality Control (QC)
Analytical Development
- Method development
- Method transfer
- Method qualification and validation
- Total error concept
- Method implementation
- Updating Analytical Procedures
- Method Life-Cycle Management (MLCM)
- Lab automation
- ICH Q2(R2) – Validation of Analytical Procedures
- ICH Q14 – Analytical Procedure Development
- Analytical Quality by Design (AQbD)
- Cleaning verification
- Analytical Procedure Control Strategy
- PAT (Process Analytical Technology)
Quality Control (QC)
- Method implementation
- Batch testing and release
- Stability testing
- Safety testing
- Microbiological testing
- In-process control testing
- Compendial method compliance and testing
- Characterisation support
- Environmental monitoring
- Method qualification, validation and verification
- Method lifecycle management
- Reference Material Management
- Traceability and data integrity
- Equipment: IQ, OQ, PQ
- Equipment: Maintenance
- Equipment: Updating equipment
- Equipment: Calibration
- Laboratory efficiency (5S)
- Training and competency management
- Out-of-specification (OOS) and out-of-trend (OOT) handling
Process & Product Development
Process Development
- Protein purification
- Preparative chromatography
- Downstream processing
- Upstream processing
- Scale up
- Process characterisation
- Process Validation
- Process monitoring and controls
- Biosimilars
- PAT (Process Analytical Technology)
- Quality by Design (QbD)
- API / Drug Substance (DS) development
- Drug Product (DP) development
- Starting material characterisation
- Critical process parameters
Downstream Processing (DSP)
- Protein purification
- Preparative chromatography
- Filtration
- Viral clearance
- Purification
- Process impurities characterisation
Upstream Processing (USP)
- Bioreactors
- Cell culture media
- Expression platforms
- Cell culture and fermentation
- Cell-line selection
Formulation Development
- Excipients
- Formulation screening
- Extractables and leachables
Quality Assurance (QA) & Regulatory Affairs
- Dossier writing
- Regulatory strategies
- Change control/comparability
- Deviations and CAPA’s
- Audits and inspections
- IND/IMPD
- Post-approval changes
Manufacturing
- Scale up
- Supply chain
- Facility design and engineering
- Raw material release
- Cleaning verification
- Packaging, labelling and distribution
Laboratory Informatics & Data Integrity
- LIMS – Laboratory Information Management Systems
- ELN – Electronic Laboratory Notebooks
- LES – Laboratory Execution Systems
- SDMS – Scientific Data Management Systems
- CDS – Chromatography Data Systems
- Data integrity – ALCOA, ALCOA+
- Audit trails and user management
- System validation – CSV, CSA
- Part 11 and Annex 11 compliance
- Master data management
- Data lifecycle management
- Electronic records and electronic signatures
- Interface management – instrument and ERP integration
- Cloud validation and SaaS compliance
Guidelines & Compliance
- GMP – Good Manufacturing Practice
- GLP – Good Laboratory Practice
- GCP – Good Clinical Practice
- GDP – Good Documentation Practice
- ICH – International Council for Harmonisation
- USP – United States Pharmacopeia
- EP – European Pharmacopoeia
- JP – Japanese Pharmacopoeia
- EMA – European Medicines Agency
- FDA – Food and Drug Administration
- EudraLex – EU pharmaceutical legislation
- WHO guidelines
- ISO standards
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