Cora Henwood is a CMC Consultant at GreyRigge Associates (GRA) with over 30 years of biopharmaceutical industry experience in biological medicines development. She focuses on three core strategic areas: designing and scaling downstream process (DSP) workflows for complex biological modalities; executing technical project management to maintain development momentum; and providing expert oversight during the selection, contracting, and operational management of Contract Development and Manufacturing Organisations (CDMOs).
Expertise: Primary Service Skillsets
CMC & Manufacturing
Cora brings three decades of practical technical leadership to the downstream development, purification, and scale-up of biopharmaceutical products.
- Downstream Process (DSP) Development: Designing, optimising, and scaling robust purification protocols, chromatography workflows, and filtration strategies for biological therapeutics.
- Biologics Manufacturing: Directing clinical batch production, facility fit assessments, and operational scale-up while embedding cGMP compliance across biomanufacturing lines.
- Process Scale-Up & Comparability: Ensuring purification processes remain yield-efficient, scalable, and capable of maintaining critical quality attributes (CQAs) through scale transitions.
Programme & CDMO Management
Her extensive background in vendor management ensures external contract facilities deliver robust technical outputs on schedule.
- CDMO Selection & Management: Evaluating CMO capabilities, managing Request for Proposal (RFP) processes, and overseeing third-party development and manufacturing campaigns.
- Technical Project Management: Leading cross-functional technical teams to manage risk, track timelines, and ensure seamless delivery across all stages of bioprocess development.
Additional Technical Specialisms
To ensure comprehensive support across the full development lifecycle, Cora also provides expert consultancy across these core GRA service areas:
- Formulation Development & Stability: Aligning downstream purification outputs with drug substance formulation and stability requirements.
- Assays & Quality Control: Working alongside analytical teams to establish robust purification controls and impurity profiling (HCP, DNA, leachables).
- QA & Regulatory Affairs: Authoring and reviewing downstream CMC modules for regulatory filings with the MHRA, FDA, and EMA.
If you would like to discuss your project with Cora Henwood or require specialist advice, please get in touch.
