Provider of guidance and practical support for Biologics, Life Science and surrounding industries with special focus for:
- Product Quality
- Analytical strategy
- CMC
- Interface between manufacturing process and analytics
- Client interrelationships
- Service Offerings
- Scientific advice and insight into industry trends, competitors and emerging therapeutic modalities.
- Company strategy for analytical services.
- Structure.
- Investment.
- Efficiency, on-time delivery and first-time right.
- GMP / Quality choice.
- Training.
- Mentoring.
- Subject matter expert on analytical methods, technologies and strategies.
- Current technology.
- New technology.
- High throughput technology.
- Analytical Development strategy.
- Typical and atypical molecules and hosts.
- E.coli, CHO, mAbs, ADCs, modified proteins and structures.
- Biosimilars, NBE, Comparability studies.
- Release testing, ICH Q6, Specification setting.
- Analytical Method Transfer
- Analytical Methods Harmonisation
- Analytical Method Lifecycle Management (Development, Qualification, Validation); ICH Q2, ICH Q14.
- Product characterisation studies.
- Formulation Development, Degradation and Stability Studies.
- Process interface with Analytics
- CQA definition, CPP definition, IPC strategy.
- RA, FMEA, Process design from CQA perspective, Process characterisation.
- Process Analytical Technology (PAT); on-line, in-line, at-line and off-line testing.
- Process adjustment to maintain CQA profile.
- Data interpretation, experimental designs, problem solving, CAPAs.
- Expert in Host Cell Protein, and related process and analytical strategies.
- Technical due diligence of RFIs and RFPs; new client screening, proposal review, recommendations for adoption, resource and equipment investment strategies.
- Resource estimation, forecasting and standardisation.
- Representation at new and existing client meetings.
- Laboratory fit, design and infrastructure.
- Technical report writing and reviewing (internal, client or regulatory).
CQA Bio Consulting 