Vaccine process & formulation development

Situation: Accelerating Viral Vaccine Process and Formulation Readiness

A US site of a multinational pharmaceutical company required specialised support to advance their viral vaccine, currently in Phase II clinical trials, towards commercial readiness. Their critical challenges included:

• Process Understanding: Deepening the understanding of the manufacturing process and identifying Critical Process Parameters (CPPs) to ensure the process was robust and suitable for the upcoming Process Performance Qualification (PPQ) campaign, in preparation for Phase III clinical trials.
• CDMO Engagement: Identifying, vetting, and engaging a suitable Contract Development and Manufacturing Organisation (CDMO) capable of handling the drug product production.
• Formulation Development: Developing and optimising a commercially viable lyophilised product (freeze-dried) for enhanced stability and logistics.

GRA Involvement: Expert Process Development, CPP Definition, and CDMO Strategy

GreyRigge Associates (GRA) provided focused, hands-on support, leveraging our deep industry expertise and experience in process and formulation development:

• CDMO Identification & Engagement: Strategic identification and engagement with qualified CDMOs and CMOs capable of supporting large-scale drug product production.
• Lyophilised Product Development: Providing technical support and formulation expertise to assist the client in developing a robust, commercially scalable lyophilised (freeze-dried) product.
• Process Understanding & Optimisation: Leading activities to significantly improve the client’s understanding of the manufacturing process, focusing on identifying, characterising, and controlling Critical Process Parameters (CPPs).

Value Added: Successful Commercial Scale Up and Regulatory Approval

GRA's involvement delivered high-impact, verifiable results, demonstrating our authoritativeness and building client trustworthiness:

• Commercial Formulation Success: Assisted the client in the successful development of a commercially scalable lyophilised product, achieved through collaboration with specialist organisations.
• CDMO/CMO Selection & Launch: Successfully identified and engaged a suitable CMO that went on to produce the drug product for Phase III and, critically, facilitated the product's successful launch following EMA licence approval in 2023.
• Process Risk Mitigation (QbD): Performed comprehensive risk assessments using Failure Mode and Effects Analysis (FMEA), aligned with Quality by Design (QbD) principles. This defined the CPPs that directly impacted product Critical Quality Attributes (CQAs), providing the essential information used during the subsequent PPQ of the process.

Click here to read what the client said about GRA and our successful partnership.