Development of a scalable manufacturing process

Scalable Manufacturing Process & CMC Strategy for a Live Attenuated Viral Vaccine

The Situation: IND Readiness and Manufacturing Scalability

A US-based biotech required urgent assistance in preparing their live attenuated viral vaccine for Phase I clinical trials. Their core challenge was twofold:

• Establishing a scalable manufacturing process with a CMO that was robust enough for Phase I but strategically designed to easily transition to large-scale production for Phase II and Phase III trials.
• Ensuring all in-process testing and bulk drug substance assays were qualified and compliant with regulatory standards prior to the Investigational New Drug (IND) submission.

GRA's Involvement: Strategic CMC and Regulatory Oversight

GreyRigge Associates provided critical, multi-faceted oversight to de-risk the program and accelerate its IND submission:

• CMO Management & Process Design: We provided hands-on oversight to the Contract Manufacturing Organisation (CMO), ensuring the developed live attenuated viral vaccine process was both efficient and scalable from its initial lab stage.
• Analytical Qualification: We ensured all necessary assays for in-process control and product release were properly qualified and documented, meeting the requirements for initiation of Phase I clinical trials.
• Product Specifications: We leveraged our expertise to guide the setting of appropriate and defensible initial product specifications aligned with the clinical stage.
• Regulatory Submission: We were instrumental in drafting and submitting the crucial CMC components of the IND application, actively engaging with the FDA regulatory interactions to address all comments efficiently.

Value Added: Successful First-in-Human & Future-Proofing

Our strategic and technical involvement resulted in immediate success and long-term value for the client:

• Clinical Trial Material: Successfully collaborated with the CMO to develop a scalable and efficient manufacturing process that generated First-in-Human clinical trial material on time.
• Regulatory Compliance: Supported the organization throughout their CMC FDA regulatory interactions, securing successful clearance to proceed to Phase I.
• Quality Foundations: Provided expert review of assay qualification protocols and reports, and offered essential guidance on the preparation and characterisation of Master Cell Banks and Virus Seeds, forming a robust quality foundation.
• Fundraising Support: Helped support the company's financial goals by confidently presenting the robust CMC strategy to potential investors during fundraising initiatives.