During an unprecedented year, Rentschler Biopharma continued to meet the demands of its core protein therapeutic business while expanding into novel therapeutics. The CDMO continues to expand and innovate beyond the pandemic by pioneering digitized processes and adding capabilities in response to client needs. The company offers services along the entire biopharmaceutical value chain — via both in-house expertise and an array of best-in-class strategic alliance partners. Senior Vice President for Business Development Federico Pollano explains how the company is leveraging its 50-year experience and dual sites in Germany and the United States to flexibly meet market demand.

David Alvaro (DA): How would you characterize Rentschler Biopharma’s mission and vision, and how has that evolved over time?

Federico Pollano (FP): Rentschler Biopharma’s mission is to empower our clients to help patients with serious or rare diseases by converting medical research into outstanding biopharmaceuticals. The company has a rich 50-year history in biotechnology and is a 100% dedicated CDMO partner.

We have deep roots within the industry, because we are constantly improving, updating our capabilities, and expanding to remain innovative and stay ahead of demand. The industry recognizes this dedication, which is why we are considered best in class in service quality, as well as regulatory affairs — including regulatory support, CMC consulting, and outlining the product path from concept to registration. Beyond this, our project managers seamlessly interface between internal operations and clients, bridging the gap between both sides to achieve optimal outcomes. Although we are a mid-sized CDMO, we take advantage of our capabilities by embedding flexibility into the organization and consistently incorporating client feedback.

DA: Do you think the perception and awareness of the company are similar across the markets where you work?

FP: We primarily service Europe, the United States, and Japan. In all three markets, quality and flexibility are key to maintaining a close relationship, as is trust. The fact that we’re able to uphold and surpass these standards makes us attractive globally. Particularly in Japan’s notoriously stringent environment, it’s to our credit that local biotech and pharmaceutical companies routinely recommend us.

DA: Where along the value chain can Rentschler Biopharma support your clients?

FP: We support the entire biopharmaceutical value chain from start to finish in collaboration with our strategic alliance partners. We are a global leader in cell culture and are also known for our service solutions from clinical through commercial supply — Rentschler Biopharma supports our clients with tailored programs from the first concept all the way to market.

This includes solutions for cell line development, including scalable CHO cell lines. Our own expression platform for standard and difficult-to-express proteins is a good example of our strong capabilities

Our services are carried out in-house — we have a tech transfer team; a strong Manufacturing, Science & Technology team; and Quality Control throughout, as well as state-of-the-art equipment. Our Laupheim, Germany facility is outfitted with 1,000-, 2,000-, and 3,000-liter capacity, allowing us to flexibly work in a range of scales. In addition to stainless steel and fed-batch continuous processing, we also offer single-use technologies, which is another differentiator.

We enter strategic alliances along the biopharmaceutical value chain with best-in-class partners that complement our core world-class services. By approaching everything from our clients’ perspectives, we provide the most efficient solutions for their projects.

This mindset prompted our collaborative alliance with Vetter Pharma, the aseptic filling and packaging expert. Similarly, we have a partnership with Leukocare for fully integrated formulation development. Together, we offer our clients access to the entire value chain so they can seamlessly transition from drug substance to drug product.

DA: Are you open to building additional strategic alliances and collaborations going forward?

FP: Yes, we are strong believers in the potential of collaboration to better understand what clients need, so that we can continue to offer optimum solutions. Moreover, we are further strengthening our existing strategic collaboration with both Vetter and Leukocare. For example, Leukocare has joined us in the United States, facilitating integrated alliance capabilities and enhanced service for our North American clients. Furthermore, we are of course currently investing heavily in the expansion of our site in Milford, Massachusetts.

DA: How do the Laupheim and Milford sites work together to create a unified offering with a single company culture?

FP: Our Milford site has been integrated into the broader Rentschler Biopharma system from the start, and the collaboration between the sites has been extremely fruitful. One of our first partners and clients in Milford was Genmab; this collaboration has been very successful on both sides and is indicative of our client relationships overall.

There is continued client interest in our expansion plans, and we are on track to continue steady growth. Following our recent groundbreaking, we plan to quadruple our 2,000-L capacity by the end of 2023. The biopharma CDMO market is increasing by double-digit numbers, and Rentschler Biopharma U.S. will play a pivotal role in our plans to continually outperform the overall market development. This new site will double our commercial cGMP manufacturing capacity.

From a positioning perspective, we will continue to remain focused on development programs, whereas Rentschler Biopharma U.S. will strongly enhance our value proposition in commercial manufacturing, although there will be an overlap in both areas at both our sites. The Milford site has a multi-production setup, allowing large quantities of material to be manufactured in a given time — we are looking forward to beginning operations as soon as possible.

A unifying factor between both locations is the corporate culture, with all team members receiving dedicated and personalized professional development opportunities through our very own Rentschler global academy. As a family-owned business, we maintain our core values regardless of how large the team grows. This dedication has paid off, as we are regarded as trustworthy, transparent, and above all, respectful. We create an environment where our employees love to work, and our clients always return to.  Ultimately, we offer our clients access to our work culture, which is our greatest differentiator but also the least quantifiable one. Rentschler Biopharma truly has an “international spirit,” and, even after all these years, we have not lost our enthusiasm for simplifying the complexities of biopharmaceutical production.

DA: What other new changes have the last few years brought to the company?

FP: Cell and gene therapy has also become part of our offering. The Rentschler ATMP Limited site in Stevenage, UK, which is slated to become operational next year, will concentrate on AAV and viral vector production. We plan to continue to build on our expertise, leveraging our experience in cGMP production and development. I am confident that Rentschler can address the gap between demand and available production capacity for this evolving area of therapeutic development.

DA: How are digitalization and the move toward the Industry 4.0 paradigm impacting the industry overall, your clients, and Rentschler Biopharma specifically?

FP: Digitalization and the move toward the Industry 4.0 paradigm is becoming a differentiator when selecting which CDMO to partner with. Evolving technologies like artificial intelligence, machine learning, and mixed reality (MR) are an important part of our strategic expansions and new services in the near future. Innovative technologies elevate traditional services by digital means and provide both us and our clients a competitive edge.

This is one of the key topics for Rentschler Biopharma going forward. Smart medicine is a major trend throughout the industry, and it starts with production. Our new state-of-the-art facility will be highly automated and leverage Industry 4.0 solutions. It will provide innovative digital and analytical services, such as advanced analytics yield optimization, augmented/virtual reality–enabled operations, and no-touch batch releases. This will allow us to further integrate our clients into our processes and truly embed transparency.

DA: What remains for the industry to do to truly achieve the full promise of digitalization?

FP: Perhaps the greatest need is for close interaction between all stakeholders, especially regulatory bodies.  Perhaps our greatest lesson learned from the pandemic is that beginning with close collaboration — with our clients, our strategic partners, technology providers, and regulatory agencies — is crucial for success. Fortunately for us, the company culture at Rentschler Biopharma has always been built around collaboration, communication, and transparency, so the company is very well positioned to address the challenges of today and to develop the solutions of the future — for our clients and their patients.