This past year, Rentschler Biopharma, a CDMO, opened its new production line in the greater Boston area, doubling its global cGMP capacity, and recently expanded its cell & gene therapy offering in Stevenage, UK to include lentiviral vector manufacturing.

The multi-product facility in Milford, MA, is focused mainly on commercial production of highly complex molecules. The new production line has added 22,000 square feet of manufacturing cleanroom space and houses four new 2,000L single-use bioreactors, bringing the total of production lines at the site up to three.

In addition to talking about Rentschler’s recent investments, COO, Christiane Bardroff provides insights on the industry and where it’s heading, as well as key issues impacting Rentschler Biopharma and the overall industry, including the Biosecure Act.
 
Contract Pharma: Can you discuss Rentschler’s recent investments in biomanufacturing and the cell & gene therapy space?

Christiane Bardroff: As a globally operating CDMO, Rentschler Biopharma’s strategic investments are shaped by client needs, industry advancements and innovation. This summer, we launched a new, state-of-the-art production line at our Milford site in the greater Boston area. This marks the largest investment in our more than 150-year history, enabling us to provide integrated services across the biopharmaceutical value chain, while strengthening partnerships with existing clients and welcoming new ones.

In 2021, we made a deliberate investment in the cell and gene therapy sector, leveraging our process development and cGMP manufacturing expertise. Recently, we expanded our offerings at this center of excellence for advanced therapies in Stevenage, UK, by introducing a new lentiviral vector (LVV) manufacturing toolbox to complement our existing adeno-associated viral (AAV) vector services. As LVVs gain prominence, this expanded capability ensures we can continue supporting innovators in this dynamic and fast-growing field.

Contract Pharma: What are the key issues impacting Rentschler Biopharma and the overall industry?

Christiane Bardroff: Geopolitical shifts are increasingly influencing how companies choose their CDMO partners. At Rentschler Biopharma, we are committed to navigating this complex landscape, ensuring compliance with local and international regulations while maintaining the flexibility needed to serve global clients. Our focus remains on delivering high-quality development and manufacturing solutions for therapies, as demonstrated by our contribution to nearly 25% of biopharmaceuticals approved by the U.S. FDA in 2023.

The rise of precision medicine is reshaping the industry, and we’re well-positioned to manage the complexities of advanced protein modalities like bispecifics, as well as gene therapies, with our regulatory expertise. Tariffs on imported supplies are another challenge, but our sourcing capabilities in both Europe and the U.S. ensure we can adapt swiftly. Additionally, like many industries, the biopharmaceutical sector faces a talent gap. To address this, we continue to invest in personnel development through apprenticeship programs and education initiatives across our sites.

Contract Pharma: What are your thoughts on the BIOSECURE Act and the potential impact on the industry?

Christiane Bardroff: At Rentschler Biopharma, we are committed to providing the highest quality services to our clients while strictly adhering to regulatory requirements. This commitment remains steadfast, regardless of the geopolitical environment. We understand that for many clients, these times can feel uncertain, and we are here to support them in navigating these evolving challenges with confidence.

We understand that the Act addresses important concerns related to national security and the resilience of supply chains. As a global CDMO, we respect the need for secure and reliable supply chains, especially in a sector as critical as biopharmaceuticals. At the same time, we recognize that implementing such measures may require careful planning to avoid potential disruptions. Looking ahead, if the legislation is enacted, it is likely to encourage companies to diversify their supply chains and explore new partnerships, fostering innovation and collaboration within the industry.