BIO
In the last decade, advances in molecular engineering have brought new technologies into the biopharmaceutical space — and with them, a diverse range of new therapeutics.
Novel drug modalities such as mRNA vaccines became well known following the onset of the COVID-19 pandemic, and they have changed the way we approach the treatment of complex diseases such as infectious diseases and potentially cancers.
One modality that has been making headway in the oncology space relies on oncolytic virus production. Oncolytic virus therapies use native or modified viruses that infect and destroy tumor cells. Although they are potentially life-changing for many patients, bringing these therapies to market is not a simple task.
The introduction of oncolytic virus therapies brings about multiple challenges, including:
- Choice of virus platform
- Selection of therapeutic transgenes
- Production cell line and drug substance manufacturing process
- Translatability of pre-clinical animal models
- Oncolytic virus delivery (e.g., i.t. versus i.v.)
- Scale of clinical grade manufacturing
- Drug Substance and Drug Product specifications
- Combination therapy (working alongside other immunotherapy, or chemotherapy, radiation therapy)
Oncolytic virus developers must consider which cell culture method is most appropriate: suspension or adherent? From there, another decision follows: which method of virus recovery and purification strategy would be best? That is before analytical methods are even considered, which are commonly a mix of inhouse and outsourced activities.
On the journey to market, scaling up and commercialisation of oncolytic viruses can raise further issues that can be hard to predict. Most importantly, the product must hit critical milestones such as successful investigational new drug applications to progress to human clinical trials.
The need for these vital drugs has resulted in pressure to hit these goals rapidly. This demand for speed is also reflected in timelines from investors, who want to see returns on their investments. This has resulted in manufacturers taking calculated risks to accelerate manufacturing timelines. Developers must hit the sweet spot between maintaining quality and speed, which is no easy task.
To find out more about how to address these manufacturing challenges, including preclinical to commercial scale up, read what Dr. Kai Lipinski, Chief Scientific Officer at ReciBioPharm had to say in an article with European Pharmaceutical Manufacturer magazine.