What are “3 Key Trends” shaping the CDMO industry in 2023 and beyond? Harald Oberegger, Novartis’ global head of business development for its CDMO unit, called Global Biotech Cooperations, shares his thoughts with Contract Pharma.

Comprehensive data security
Managing and protecting sensitive data is also gaining traction in the biopharma industry, where it requires an established life cycle process. Data security includes almost everything: from the hardware used, the established software and programs, storage and user devices, access, and administrative controls, as well as companies’ policies and procedures. It protects data from unauthorized access from the start to the end of a program and beyond, and this is quite important especially in the field of advanced therapies like cell and gene, where samples from a patient (such as blood) are used in the manufacturing process.

The demand for advanced therapies is increasing worldwide. To meet such a rising demand, Biopharma companies are turning to CDMOs to outsource both development and manufacturing activities.

Yet not all CDMOs can offer the same level of digital trust. Biopharma companies are keen to understand the processes and systems in place to protect the patient’s identity among other aspects. They want to restrict access on a strict need to know basis for the limited scope of their respective task. Pharmaceutical companies who are pioneers in bringing cell and gene therapy products to market may have a competitive edge in handling the sensitive data of patients in comparison with those CDMOs who are relatively new in the cell & gene space.

Adapting to technological advances in manufacturing
Today biopharma companies are expanding their pipelines in many different therapeutic areas and this diversity is reflected in the underlying technologies needed to manufacture such complex products. These technologies are advancing almost every day and it can be vital for biopharma companies to have a strategic partner who can adopt new technologies at rapid speeds, while keeping the ability to deliver products reliably and with the desired quality.

In the field of cell and gene therapy, flexibility is key to be able to meet new needs. This includes not only the manufacturing process, but also the flexibility in adapting to meet changes in actual demands within a short period of time. That means CDMO’s need to account for such flexibility. There are various unique challenges when it comes to cell and gene manufacturing, but when one can count on a global manufacturing network, exceptional expertise at different levels of operations and a willingness to help customers bring their life changing therapies to patients as fast as possible, it is easier to meet the flexibility demanded from GBTC acting as a CDMO.

Sustainable manufacturing practices
The harmful effects of climate change have been gaining a high degree of prominence. This requires imminent and sustained action by all stakeholders. Therefore, we expect that sustainability will become more and more relevant for all CDMO players, as pharmaceutical companies take proactive actions and define sustainability roadmaps to deliver value chain emission reductions.

At Novartis, we are committed to protect our people, the planet and patients from climate change. Building Green Operations of the future is embedded in our business objectives. Our ambition is to be a net-zero by 2040, plastic neutral and water sustainable company by 2030.

We have a strategic approach in place to deliver our climate targets. Our approach is built around two key priorities—the first one being to reduce the consumption of natural resources (like electricity, steam, material, water etc.) through process innovations and efficient technologies. For the part that can’t be reduced, we aim to switch to clean and renewable solutions.

Our approach has led to significant impact in reducing our environmental footprint. In 2022, we reduced our emissions (from own operations) by 23% from the prior year, representing a reduction of 49% compared with our 2016 baseline. We are committed to using 100% renewable electricity across our operations by 2025. In 2022, we also had renewable power purchase agreements in place to cover electricity consumption across our operations in Europe and North America. Like all other pharma companies, more than 90% of our emissions are associated with the value chain. So, our suppliers play a key role in our sustainability journey. We are integrating the Environmental Sustainability Criteria in supplier contracts to onboard them in our journey and engaging with suppliers to define sustainability roadmaps to deliver value chain emission reductions.