BIO
Overcoming oncolytic virus obstacles to bring new cancer treatments to market
Oncolytic viruses (OVs) are a promising and innovative approach to cancer treatment, offering a non- to low-toxic and non-invasive alternative to traditional therapies.
The selectivity and potential to enhance existing medicines have led innovators across the pharmaceutical industry to actively explore the potential of OV treatments.
However, despite some initial clinical trial successes, there are significant challenges in the development of OVs that hinder progress in this field.
Process optimisation and scale-up
When it comes to the development of OVs, a major challenge companies face is efficiently scaling up production without compromising product quality. Meeting expedited clinical readiness deadlines demands rapid development progress, and the ability to scale up production is crucial to meeting increasing clinical supply requirements.
Pharmaceutical companies can address this challenge by harnessing a multifaceted approach:
- Leveraging the expertise of subject matter experts:
Selecting partners with extensive OV manufacturing experience can facilitate the efficient transfer and modification of processes at smaller scales. This comprehensive understanding enables companies to build a robust process that enables efficient problem-solving and adaptation across various stages of manufacturing. - Effective project and program management:
A well-planned and executed project plan helps companies meet key timelines, maintain prioritisation of the right areas at the right times and streamline escalation processes. Collaborative management of material supply issues, including partnering with suppliers to address potential shortages, will also help to facilitate a smooth production flow. - Collaborative management of material supply issues:
Collaborating with suppliers to address potential shortages is key to ensuring a smooth production flow. By actively managing material supply issues, OV developers can mitigate potential disruptions and maintain a consistent manufacturing process.
Assay development and qualification
Another critical challenge in OV development is the timely development and qualification of assays. Finalising assay transfer, qualification, verification and validation promptly is crucial for ensuring reliable OV product quality assessment. This challenge is further complicated by the need to source and qualify additional outsourced testing labs for certain assays that are not available in-house.
Product yield and dosage requirements
- Ensuring high product yield and meeting dosage requirements:
Crucial in OV development for clinical use is designing processes that consistently produce high yields with a high titer, low total particle, infectious particle ratio, high process recovery and a compliant process residual profile to ensure a reliable and high-quality product. - A streamlined process development approach:
By conducting multiple process development studies, companies can optimise both their upstream and downstream parameters, ensuring the development of a robust process capable of meeting the yield and quality requirements of their OV project.
In our latest article with IBI Magazine, Kai Lipinski, Chief Scientific Officer at ReciBioPharm, dives deeper into the obstacles faced by OV developers. He also explores how working with specialist CDMO partners may hold the key to bringing these groundbreaking treatments closer to patients.
