CPHI Americas 2025: Meeting Biomanufacturing Demand
As demand for biologic drug substance manufacturing rises, The Pharma Navigator, chats with Carrie Bracco from Novartis Contract Manufacturing about how this trend is impacting service providers, the challenges facing CDMOs in the space, and the benefits of strategic partnerships.
Biologic-based drugs have rapidly surged over the past few years, offering effective treatment options, even sometimes curative options, for a broadening pool of therapeutic indications (1). However, these promising therapies are more complex to handle and manufacture than traditional small-molecule pharmaceutical drugs, leading to a greater need for specialist expertise and capabilities to ensure success.
The biologics drug substance manufacturing market is forecast to grow at a compound annual rate of 10.59% between 2025 and 2032, driven by factors such as the increasing prevalence of chronic disease, greater adoption of biologics globally, and technological advancements (2). To better understand how the growing demand for biologic drug substance manufacturing is impacting service providers, the challenges facing CDMOs in this space, and the benefits of strategic partnerships, The Pharma Navigator sat down with Carrie Bracco, Head of Business Development US at Novartis CDMO, which is focusing on addressing the growing demand for biomanufacturing at CPHI Americas 2025.
Racing to Meet Demand
TPN: Industry is seeing growing demand for biologic drug substance manufacturing, how has this trend impacted service providers in your opinion?
Bracco: The growing demand for biologic drug substance manufacturing has significantly impacted CDMO service providers in several keyways. CDMOs are racing to expand capacity, building new biologics facilities, or retrofitting existing ones to meet demand. There’s heavy investment in single-use systems, modular cleanrooms, and larger bioreactors to increase flexibility and scale. To stay competitive, CDMOs are broadening their offerings to include development, analytical, regulatory, and fill/finish services, aiming to be one-stop shops. Many are moving into emerging modalities (e.g., mRNA [messenger RNA], cell and gene therapy), where Novartis has extensive experience of supplying commercial products. Novartis Contract Manufacturing is overcoming challenges of limited production capacity and technical complexity by leveraging our state-of-the-art facilities and expertise to facilitate manufacturing drug substance for all the life cycle stages (older and newer processes).
Numerous Challenges
TPN: Are there any specific challenges that are facing CDMOs in relation to biologic drug substance manufacturing? How are CDMOs overcoming these challenges?
Bracco: CDMOs in biologic drug substance manufacturing face challenges such as technical complexity, regulatory hurdles, high capital costs, supply chain issues, and the need for highly customized services. Surging demand for biologics, including monoclonal antibodies, cell and gene therapies, and mRNA products, often exceeds existing manufacturing capacity. Also, biologics require sophisticated processes (e.g., upstream cell culture, downstream purification) that are technically demanding and often product-specific. To overcome these challenges, CDMOs are rapidly expanding facilities, often through modular or prefabricated cleanroom construction and investing in single-use bioreactors and flexible platforms to reduce lead times and to increase scalability. Standardized downstream purification platforms for multiple products help increase efficiency. As an innovator ourselves, Novartis Contract Manufacturing can offer flexible solutions to overcome these challenges.
Benefits of Strategic Partnerships
TPN: You are participating in the CDMO Panel on May 20, 2025, which will be examining strategic partnerships in more detail. In relation to this session, could you run through the specific benefits innovators/sponsor companies can gain through ‘strategic partnerships’ for biologic/mammalian drug substance services?
Bracco: Strategic partnerships with CDMOs such as Novartis for biologic/mammalian drug substance services offer several specific benefits for innovators and sponsor companies. Through such partnerships it is possible to address the growing demand for biologic drug substance manufacturing, including monoclonal antibodies, cell and gene therapies in addition to production capacity, technical complexity, and regulatory hurdles by leveraging state-of-the-art facilities and expertise. A range of technology platforms such as DNA, cell therapy, gene therapy, cell banking, mammalian and microbial biologics, are offered. The expansion of capacity along with footprints in multiple regions makes logistics easy. For example, Novartis has a global presence with multiple sites worldwide in Asia, Europe, and the U.S.; this extensive network supports a robust supply chain and competitive pricing. This support helps companies deliver capacity, quality, and speed in their drug development processes and lifecycle management of commercial products.
Focusing on the Growing Demand
TPN: What is Novartis Contract Manufacturing most looking forward to at CPHI Americas this year?
Bracco: At CPHI Americas 2025, Novartis Contract Manufacturing is focusing on addressing the growing demand for biologic drug substance manufacturing, including monoclonal antibodies, cell and gene therapies. We are leveraging our state-of-the-art facilities and expertise to overcome challenges such as limited production capacity and technical complexity. We are also emphasizing our commitment to innovation and reliability, aiming to be the manufacturing partner of choice by solving clients’ manufacturing challenges and leveraging our extensive experience. Novartis is making significant investments in expanding our U.S.-based manufacturing and R&D footprint, which includes building new facilities and increasing production capacity to produce key medicines end-to-end in the U.S. We are looking forward to connecting with customers and making new connections to discuss how we may support them with our global manufacturing network.
TPN: Can you highlight any specific innovations that Novartis Contract Manufacturing will be presenting at the show?
Bracco: Novartis Contract Manufacturing provides development and manufacturing services in different technologies and treatment modalities, ranging from mammalian, microbial with different expression mechanisms to highly complex therapies like Cell & Gene, mRNA etc.
We are particularly excited about sharing our investment progress in the large-scale mammalian space as it will expand our capacity to accommodate the increasing demand in biologics, not only for Novartis medicine, but also for potential customers.
We have also recently opened our first European viral vector facility in Slovenia, aiming to meet the demands of advanced therapies.
Overall, we look forward to the discussions with biopharma companies about how we can lend our services in bringing their medical innovations to life in CPHI Americas.
TPN: Where can visitors find Novartis Contract Manufacturing at CPHI Americas?
Bracco: At CPHI North America, the Novartis Contract Manufacturing team will be on-site and ready to connect with you at Booth #1307 (May 20–22). Pennsylvania Convention Center, Philadelphia.
References
CAS. The Rise of Biologics: Emerging Trends and Opportunities. White Paper, 2023.
DelveInsight. Biologics Drug Substance Manufacturing — Market Insights, Competitive Landscape, and Market Forecast — 2032. Market Research Report, February 2025.
Carrie Bracco will be a member of the panel for the ‘CDMO Panel: Tackling Pharmaceutical Pain Points Through Strategic Partnerships’, taking place on Tuesday May 20, 2025 at 12:15 pm in Room 201A. If you would like to attend this panel discussion, registration is required. Visit the event website for more information, or read The Pharma Navigator’s event preview article, where the editors provide a snapshot of what to look forward to at CPHI Americas.