CPHI Barcelona Keynote Preview - Mapping the journey to commercial starts at proof of principle completion

Ahead of his session at CPHI Barcelona, which explores the current state of the CDMO landscape, Vinay Saluja (VS) – global head development services at Novartis Global Biotech Cooperations, contract manufacturing unit of Novartis – discusses the specific considerations in outsourcing for biologics and cell and gene therapies.  

How has the role of the CDMO changed in recent years?

In the past 2-3 years we have received increased requests for other, newer technologies like Cell & Gene therapies and RNA as well. These emerging technologies may represent both an opportunity and a challenge for some companies, struggling to get the required capacity and the best quality to bring their medicines to patients in the right timeframe. 

Here is where we could immediately help some of them to manufacture their medicines to patients as we have built the capabilities of these technologies over years. For other technologies like mammalian, microbial, fill and finish, we´re actively engaging in strategic partnerships to offer end-to-end services (e.g. Drug substance and Drug product) manufacturing under one quality system. 

How do you approach working with a smaller biotech vs a larger biotech, or biotechs in different regions?

We´re having a customer base of companies of all sizes. Our unique global contract manufacturing network offers tailor-made development and manufacturing services at high quality as per the needs of the customer. We have capabilities that can cover the needs of both clinical and commercial products. Products in clinical stages require more development support to advance to the commercial phase. Our vast experience in tech transfers and scale-up has proved to bring customer products successfully to the market from clinical to commercial scale.

How would you differentiate yourself in terms of cell and gene therapy?

The key benefit of Novartis acting as a large Contract Manufacturing Organization is our manufacturing and development network. Combined with our highly regarded capabilities - our skills, assets, and people, we believe we can help other companies bring more innovative products to patients: 

• We can deliver high-quality medicines in a sustainable manner. 

• Our financial stability and commitment to capacity allow reliable long-term cooperation. 

• We have proven regulatory and logistical strengths. We can offer a stable and sustainable global supply chain, as we have long-standing relationships with a network of global suppliers. 

How do you approach phase-appropriate development and plan development projects?

A Quality by Design approach is followed to map this journey and successfully build each phase of development. This involves identifying essential steps for process development and ensuring it is developed successfully. Each phase comprises of dedicated work packages like process development, process characterization and process validation.