BIO

Oncolytic virus (OV) therapeutics are revolutionising cancer treatment, providing groundbreaking new options for patients. By using modified viruses that selectively target and destroy cancer cells while sparing healthy cells, OV therapies offer a well-tolerated alternative to traditional treatments such as chemotherapy and radiation therapy.

This innovative approach minimises unpleasant side effects and can offer vastly improved patient outcomes. However, the development and manufacturing of these therapeutics face various challenges, particularly across process development (PD), supply assurance, scaling up and meeting key milestones. Overcoming these obstacles requires expertise and capabilities in OV development and manufacturing to ensure project success and mitigate potential risks.

When a pioneering biotech company needed support to progress its oncolytic adenovirus therapy, it approached ReciBioPharm and our team of experts got to work.

 
The challenge 

The biotech faced tight time constraints to swiftly transition from PD of its therapy to GMP manufacturing to deliver its groundbreaking flagship product to first-in-human clinical trials. The company had one year to meet this deadline, and failure to do so risked potential investment consequences.

 
Faced with external factors such as the COVID-19 pandemic and supply chain disruptions, meeting this ambitious timeline would have been daunting without access to the necessary capabilities and experience in this area.

Other challenges included: 

  • Process/product development and scaling complexities
    The drug substance (DS) manufacturing process required extensive modification to achieve high drug product (DP) titers. It also required the downstream process to be redesigned to achieve robust performance, low particle ratio, high recovery, and compliance with FDA and WHO guidelines, especially concerning host cell DNA and residual specifications. These modifications were crucial for advancing the project through clinical trials with escalating doses.
  • Transition and process obstacles
    Without an intermediate engineering batch, seamlessly transitioning from PD to GMP proved to be challenging. It necessitated a streamlined manufacturing process and a well-structured PD-to-GMP technology transfer approach. Simultaneously, meeting tight regulatory timelines for finalising assay transfer, qualification, verification and ICH-aligned validation was crucial to maintaining compliance and ensuring the quality, safety and effectiveness of the therapy, leading to the identification and qualification of additional outsourced testing labs for specific assays.
  • Supply and scale-up difficulties
    Securing a sustained supply required the production of a new master virus seed stock at an intermediate scale and later at a larger scale (50 L bioreactor). Scaling up DS production was essential for long-term clinical dosing and dose escalation, and process modifications needed to be implemented to achieve higher DP titers and meet growing demand during clinical trial progression.

 

However, ReciBioPharm, with its expert capabilities in high-quality and efficient oncolytic virus manufacturing at a range of scales, was well-equipped to navigate these challenges, progressing the therapy to clinical trial phases at speed.

Find out how we worked together in our latest case study: