Bio International 2024

Novartis to showcase next-gen manufacturing solutions at BIO 2024

By Isabel Cameron

- Last updated on GMT

© Getty Images
© Getty Images

Related tags Novartis Manufacturing Contract manufacturing Supply chain

Before the industry is set to arrive in San Diego for Bio International 2024, we spoke with Dr. Harald Oberegger, global head business development at Novartis Contract Manufacturing. At the event, the company will be showcasing its cutting-edge technologies, including mammalian and microbial drug substance manufacturing, cell and gene therapy and more.

BPR: What new products or innovations is Novartis showcasing at BIO 2024 this year?

At BIO 2024, Novartis Contract Manufacturing will actively demonstrate its commitment to supporting both existing and potential manufacturing partners around the globe, by showcasing its cutting-edge technologies. These capacities include mammalian drug substance manufacturing, microbial drug substance manufacturing, cell therapy, gene therapy, fill & finish plasmid DNA, mRNA, siRNA, and peptide synthesis.

Furthermore, we will highlight the significant investments made this year, including expanding our viral vector capacity to meet the production needs for gene therapies, and increasing our mammalian production capacity for oncology, immunology, and other therapeutical products. These strategic investments demonstrate our proactive approach towards meeting the evolving needs of biopharmaceutical companies and bringing high-quality medicines to patients.

BPR: What are you hoping to achieve from the event?

We want to further establish Novartis Contract Manufacturing as the manufacturing partner of choice for biopharmaceutical companies. We want to actively engage with potential future partners to gain valuable insights into their unique needs, provide concrete solutions to their manufacturing challenges, and network with industry peers.

BPR: How does Novartis stay ahead of industry trends and developments in the pharmaceutical sector?

We support our customers in bringing their high-quality medicines to market by staying ahead of industry trends and developments. This is possible because:

- We are committed to the highest quality standards and implementing robust quality systems to ensure we deliver on them.

- We have always been a pioneer in advanced therapies, including biologics, cell & gene, and xRNA.

- We consistently prioritize robust data security systems to safeguard sensitive patient information, ensuring trust and compliance in an increasingly digitized healthcare landscape.

- We have created safeguards and firewalls to prevent any exchange of confidential information concerning either Novartis or our customers.

- We are at the forefront of embracing innovative AI technologies.

- We are committed to sustainability, integrating green operations throughout our value chain to minimize our environmental impact and promote environmentally friendly practices.

BPR: What challenges is your company currently facing in the pharmaceutical market and how are you addressing them?

One of the main challenges we face is emphasizing the importance of adhering to high quality standards in the manufacturing of medicines. Compromising quality to speed up production, for instance, can ultimately lead to long-term problems, extending the overall time it takes to bring a product to market. To Novartis, speed matters, but not if we must compromise on quality.

What strategies does Novartis employ to ensure the quality and safety of its pharmaceutical products?

With over 40 years of experience in biologics manufacturing, Novartis Contract Manufacturing helps customers bring cutting-edge therapies to market, prioritizing quality by design (QbD) principles, enhanced automation, and innovative systems and processes.

As manufacturing partner, we provide our clients with end-to-end manufacturing services in mammalian and microbial manufacturing, cell & gene, viral vectors, mRNA, siRNA, and peptides. In addition to manufacturing, this also includes:

- A fully integrated set of services and solutions for aseptic fill & finish of medicinal products; manufacturing of master cell and working cell banks to enable high-quality clinical and commercial production;

- Quality assurance systems, with all facilities operating in compliance with cGMP regulations;

- An expert logistical network and proven chain of identity capabilities, ensuring the safety and security of your product;

- Advanced analytical cap?abilities for release, stability and characterization;

- Scale-up capabilities, reliable manufacturing processes and unparalleled industry knowledge;

- Life cycle services based on rigorous quality & regulatory standards.

BPR: Can you provide insights into any regulatory changes or compliance issues that are impacting your business?

We are committed to ensuring compliance and regulatory standards across all our production lines. Our recent FDA inspections yielded zero observations at our sites in Austria and Singapore. Furthermore, all of our manufacturing sites are fully both FDA, and EMA, approved.

BPR: Can you discuss any plans for expansion or market growth that Novartis has in the pipeline?

Novartis Contract Manufacturing has already invested approximately 500m EUR towards expanding our mammalian production capacity at our Kundl/Schaftenau campus in Austria. We have also invested an additional 256m USD towards expanding our biopharmaceutical manufacturing facility in Singapore, to address soaring demand in the Asian market. The expansions in both Austria and Singapore are expected to be operational in 2025.

Furthermore, we have already invested 245m EUR into our viral vector capacity at our sites in Slovenia, which are expected to be operational in the second half of 2024? 

BPR: What sets your company apart from competitors in the pharmaceutical industry, and what value do you offer to your customers?

Novartis Contract Manufacturing positions itself as a strategic manufacturing partner for the biopharmaceutical industry. To do this, we leverage our high-quality standards, robust supply chain network, and competitive pricing to best serve our clients’ manufacturing challenges.

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