Novartis looks beyond mAbs with $270m manufacturing spending spree

Novartis is making a multi-year investment across three European manufacturing sites to support a growing early-stage pipeline of next-generation biologics.

Pharma giant Novartis announced the investments this week, with facilities in Switzerland, Slovenia, and Austria set to see increased drug substance and drug product capabilities.

Specifically, $110 million will be injected in clinical manufacturing and technical development capabilities at the firm’s Mengeš, Slovenia site, while $60 million will be used to add technical manufacturing capacity at the Schaftenau campus in Austria, including pilot-scale High Density Perfused Batch (HDPB) capabilities.

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“Our investment in Austria and Slovenia is aimed at creating seamless end to end development & manufacturing environments by embedding next generation biotherapeutics development right in the heart of commercial medicine manufacturing in two established European locations,” a Novartis spokesperson told BioProcess Insider.

Furthermore, $100 million will be pumped into Novartis’s Basel, Switzerland site to establish a biologics presence and complement the site’s Novartis Institutes for BioMedical Research (NIBR) Biologics center.

The rolling early phase biologics investments will focus on meeting the needs of an “increasingly sophisticated next generation biotherapeutic portfolio,” we were told, “ensuring Novartis has the most advanced technical infrastructure matched by the highest level of capabilities.”

The company, which is spinning-out its generics and biosimilar division Sandoz, has over 30 molecules in its Innovative Medicine pipeline.

“Biotherapeutics represent a rapidly growing portion of the total pharmaceutical market accounting for almost one-half of recent new drug approvals. Monoclonal antibodies have been the most rapidly growing drug class in oncology, autoimmunity, and chronic inflammatory diseases.

“At Novartis we have seen an increasing contribution of biotherapeutics to our portfolio with the continued growth of Cosentyx, Lucentis, Xolair & Ilaris. Within R&D this trend is also visible with an increasing percentage of biologics making its way from NIBR into the development portfolio,” we were told.

“Expanding the biologics portfolio beyond mAbs into more complex molecules has unlocked biology and led to novel, more differentiated biologics development candidates, leading to significantly higher workload per project. This represents a paradigm shift in early development resulting in need for higher front‐loading of efforts in development and characterization, requiring greater scientific rigor & depth and increased speed & agility.

“This is one of the primary objectives of our commitment to this multi‐year capacity and capability build in people, technologies and clinical manufacturing.”