If there has been a single outcome from the COVID-19 pandemic for drug developers, it is the realization that, through innovation and collaboration, the industry can work faster. At the time of writing, Oxford University/Astra Zeneca’s COVID-19 vaccine “ChAdOx1 nCoV-19” has entered phase III clinical trials after less than 10 months. Typically, the industry standard to reach this stage is 4–8 years. While this is an unprecedented situation with an almost unlimited budget and the priority of governments and regulators internationally, there will almost certainly be lessons learned on how to accelerate drug development aside from COVID-19.
There continues to be an ongoing shift of early-stage biologics development work away from big biotech organizations to small and mid-size private biotechnology companies. Approximately 50% of new phase I clinical trials are now being initiated by private biotech firms that rely heavily on contract development partners. It is imperative that these CDMOs lead the charge in finding innovations to accelerate drug development and become more involved in working directly with regulators and clinical trial bodies. There are multiple ways in which Polpharma Biologics is already achieving this.
We are accelerating the development process through investment in new technology and equipment, such as our recently purchased Cyto-Mine® in cell line development that will reduce timelines and enable the production of manufacturing cell lines in 4–5 months — reduced from 9 months — with no effect on productivity or quality due to the automation of a previously time-consuming manual step.
Another step is the investment in high-throughput automated bioreactor system equipment, which replicates the conditions in industrial bioreactors at microscale, allowing the anticipation of process problems much earlier and thus further reducing process timelines. Our switch to single-use equipment also significantly speeds up production. Converting a production suite from one product to another can now be done in as little as a day; the cleaning process previously took weeks between batches in stainless steel bioreactors.
The next big development among CDMOs is the integration of end-to-end services and the ability for one contract company to support a product from discovery through to fill-finish and commercial supply. An integrated provider significantly reduces timelines by eliminating process transfer between organizations. It also facilitates easier communication, as adjustments can be immediately implemented into facility schedules. Integration also enables the overlap of processes, such as starting upstream development while stability studies in cell line development are finishing, and removes the time-intensive and risky process of transferring knowledge between contractors.
Polpharma Biologics possesses this full-service integration but has also taken a further step and combined regulatory, IP, and clinical services into the company offering — including for preclinical, clinical strategy, and clinical operations. With one partner who believes in being open, flexible, and collaborative becoming so involved with a product’s development, the passion the team has for delivering the drug to the market matches that of the developer. This leads to motivated teams, who all care about their common goal of getting products to patients as safely and quickly as possible.
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