Novartis' Industry 4.0 Tech Transforms Cell Therapy Manufacturing

12/29/2021




As medical technology has advanced, mankind has been able to find cures for more and more of the diseases which plague us. From mass-immunisation to the successful blocking and treatment of the HIV virus, the pharmaceutical industry is creating new ways to help patients live full and active lives for longer.

Cell therapy is nothing new, with the first (unsuccessful) experiments having taken place in the 19th century. However, as the technology has improved cell therapy is now showing great promise in treating fatal and/or debilitating illnesses such as cancer and MS. In cell therapy, new cells are implanted into the patient to treat an illness. For example, one of the biggest problems with cancer is the body’s inability to recognise cancer cells as foreign bodies and fight them using its own immune system. With cell therapy, new cells can be introduced which are programmed to hunt down and eliminate cancer cells.

As a major player in the pharmaceutical industry, Novartis recognises the promise of cell therapy and is planning a digital transformation around the manufacture of new treatments.

Novartis

Novartis recently laid out its plans for the next year and they include a significant investment into transforming its manufacturing network. Dubbed “Embracing Operational Excellence” – one of the company’s five strategic priorities – the transformation will focus mainly on deploying Industry 4.0 technology to give its cell therapy manufacturing processes a considerable boost.

The company has been having serious difficulties hitting label specifications when manufacturing its chimeric antigen receptor therapy which has driven the desire to implement digital transformation in this area. Cell therapies are particularly challenging in this regard as they need to be bespoke manufactured for each patient.




“[Novartis] has adapted to the challenges it is facing by changing its investment strategies away from more traditional production technologies,” said a spokesperson for the company. “To focus on advanced and transformative manufacturing platforms to support Novartis’s product portfolio move from high-volume blockbusters at the end of their life cycle to smaller volume, customised, and personalised medicines – e.g. Kymriah.”

Data and digital technology can help pharma manufacturers streamline and optimise their processes. Traditional manufacturing products are made, tested, and then released and the unfortunate result of this process is that it’s incredibly hard, if not impossible, to effectively judge the effectiveness of the product until it has reached the end of its development cycle.

However, with connected Industry 4.0 sensors the data of product batches can be integrated and analysed in real time. This allows the outcome of the manufacturing process to be predicted at all stages and enables pharma brands to become more agile and proactive when it comes to making alterations, reduce quality related write-offs, save costs, and reduce time to market.

Industry 4.0 Technology

One element of Industry 4.0 which Novartis is determined to make a cornerstone of its cell therapy digital transformation is artificial intelligence.

“[Novartis] is still exploring where best to apply AI in the manufacturing process,” continued the Novartis spokesperson. “Novartis is exploring ways for AI to help us find opportunities in our data to make more efficient purchases of materials used during the manufacturing process.”

One of the more promising applications of artificial intelligence in Novartis manufacturing is in a field service role. With connected and intelligent sensors installed in the factories responsible for producing life-saving treatments, equipment failures can be pre-empted and attended to before the machines break down completely – significantly reducing downtime and the associated loss of revenue and production capabilities.

Novartis is experimenting with ways to use digital technology and specifically artificial intelligence to assist with the planning, monitoring, and distribution of medicine to patients as well – further strengthening the pharma supply change from manufacturing to the end user.

The brand is also expanding its manufacturing capabilities in other regards as well to acquire new technology and boost its output.




Speaking about the company’s recent acquisition of manufacturing partner CellforCure, Novartis’s Global Head of Technical Operations, Steffen Lang said, “The proposed acquisition of CellforCure is yet another strategic step in our pursuit of additional manufacturing capacity to make our transformational CAR-T cell therapy, Kymriah available to more patients around the world. If completed this acquisition would potentially increase manufacturing capacity for other cell and gene therapies in the Novartis pipeline.”

Final Thoughts

Industry 4.0 technology is helping Novartis and other forward-thinking pharma manufacturers to become data driven decision makers. This is especially crucial in the realm of cell therapy and other personalised treatments which necessitates brands to be able to optimise their manufacturing process as much as possible.


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