How Hands on Expertise Accelerated CMC Delivery for a COVID-19 Recombinant Protein Therapeutic

The Situation: Desperate accelerated programme with integrated global CMC execution  

A European biotech was advancing a recombinant protein therapeutic for COVID-19 following positive Phase I data. The programme was rapidly progressing toward accelerated clinical trials within the USA under Operation Warp Speed (later renamed Countermeasures Acceleration Group (CAG)), with the objective of enabling emergency use. 

Drug substance was manufactured outside Europe and shipped into Europe for fill and finish. The client had strong clinical and R&D capabilities but limited internal CMC expertise. The programme required increasingly rapid integration of process, analytical, quality and regulatory activities across multiple CDMOs under newly compressed timelines. 

GRA Solution: Hands-on CMC leadership across multi-CDMO global supply 

GreyRigge Associates were brought in to provide leadership across all technical and regulatory areas, acting as an integrated, hands-on CMC function, to guide and improve efficiency. Key operating activities included:

• CMC strategy and roadmap 

Defined and implemented an integrated CMC strategy aligned to accelerated clinical timelines. 

• CDMO oversight and coordination 

Led interactions with non-European drug substance and European drug product CDMOs, ensuring alignment across manufacturing and supply. 

• Supply chain and tech transfer integration 

Managed drug substance to drug product transfer, including packaging, labelling, serialisation and pharmacovigilance considerations. 

• Analytical and QC release strategy 

Established release frameworks for drug product, including assay strategy, statistical evaluation and quality control alignment. 

• Comparability and stability programmes 

Designed and oversaw protocols, execution and reporting to support regulatory progression and shelf-life assignment. 

• Regulatory and quality support 

Contributed to regulatory dossier development and supported technical agreements, batch record review and QP-to-QP interactions. 

• Programme leadership 

Provided end-to-end project management across all functions and partners. 

Value Added: Delivered integrated CMC under timeline pressure, de-risking execution 

GRA enabled rapid progression of a complex, multi-CDMO programme under accelerated timelines. 

• Accepted into Operation Warp Speed / CAG with positive FDA interactions 

• Timelines achieved under significant programme pressure 

• Major CMC risks mitigated, including comparability and supply continuity 

• Programme advanced and preparation started for accelerated PPQ 

Although the programme did not fully progress due to the evolving COVID clinical landscape, GRA delivered to plan; a fully integrated, regulatory-ready CMC package under compressed timelines, demonstrating the ability to lead complex, accelerated development programmes and manage multi-region supply chains. 

Service Areas: CMC, Analytical, QA, Regulatory Affairs, Statistics, Project Management