Rentschler Biopharma SE

Biologics

Bioprocessing

CDMO

Industry Leader Insight

Q3 2018

<h6><span style="color: #0072bc">Industry Leader Insight</span></h6>
<h3><span style="color: #005891">Biopharmaceutical drug developers are increasingly relying on contract development and manufacturing organizations (CDMOs) to provide the specialized knowledge, expertise and technologies required to accelerate the development and commercialization of these important medicines. Dedicated CDMOs that are focused solely on serving their customers — and who can also provide integrated support throughout the development cycle — have a distinct competitive advantage in the biopharma market.</span></h3>
<h4><span style="color: #0072bc">Long-Term Experience in Biologics Development</span></h4>
<p>As one of the world’s oldest biologics firms — developing and producing biopharmaceuticals since 1974 — Rentschler Biopharma is a pioneer in the field. We began working with recombinant cell lines in 1979 and received the first ever market approval for a natural interferon <em>β</em> (Fiblaferon<sup>®</sup>) in 1983. We expanded our portfolio in 1989 with the approval of Polyferon<sup>®</sup>, a recombinant interferon <em>y</em>.</p>
<p>Recognizing the growing need for dedicated contract manufacturing support in the biopharma industry, Rentschler Biopharma restructured in 1997 as a dedicated service provider committed to providing development, manufacturing and consulting support to drug companies focused on biologics.</p>
<p></p>
<p>Beginning in the 2010s, Rentschler Biopharma was one of the first CDMOs to install 1000-L single-use (SU) bioreactors. We were also the first company to produce commercial batches in a 2000-L SU bioreactor. Rentschler Biopharma also leverages downstream disposable technologies, including SU chromatography, tangential flow and viral filtration systems, which have been in use since 2010.</p>
<p>Rentschler Biopharma has been an outsourcing partner for more than 130 clients, providing contract development and manufacturing of biopharmaceuticals in mammalian cell culture for small, medium and large pharma and biotech companies around the world. We have experience with over 250 different biomolecules, including antibodies, fusion proteins, enzymes, cytokines and growth factors.</p>
<p>Continued investments in state-of-the- art equipment, innovation and partnerships have positioned Rentschler Biopharma among the global leaders focused on mammalian cell culture. We are a family-owned, 100% dedicated CDMO offering end-to-end solutions throughout the life cycle, while setting new standards in client focus, individual customized solutions and reliability.</p>
<div class="callout">
<h4 class="callout-title"><span style="color: #005891">Rentschler Biopharma&#8217;s end-to-end services cover the entire biopharmaceutical value chain from gene to vial and from clinic to market.</span>&nbsp;</h4>
</div>
<h4><span style="color: #0072bc">A Smart Bioprocessing Approach</span></h4>
<p>Biologic drug substances are increasingly complex, and as such their sophisticated biomanufacturing is exceedingly challenging. Advances in automation and process analytics are driving the generation of massive quantities of data that must be standard and compliantly processed. Regulatory requirements are increasing while development timelines are decreasing, making project management more exciting and inspiring.</p>
<p>There is consequently a strong drive to improve efficiency and productivity with a concurrent view toward the highest safety and product quality. Rentschler Biopharma has adopted a “smart bioprocessing” approach that enables the generation of robust and reproducible cGMP-ready bioprocesses. Intensive and iterative use of <em>in silico</em> approaches, including bioinformatics, advanced modeling tools and lab-scale analytics allow optimization of critical steps that lead to reduced costs, time and effort.</p>
<p>With this modular approach, Rentschler Biopharma is able to design and implement scalable manufacturing processes rapidly and efficiently. Processes are developed that meet desired criteria for overall yield, achieve critical quality attributes and include final downstream processing specifications ready to scale up for production. The goal of smart bioprocessing is to front-load critical analytic steps to optimize and verify process designs as early as possible, even before moving into small-scale production.</p>
<h4><span style="color: #0072bc">Truly Dedicated CDMO</span></h4>
<p>Rentschler Biopharma is committed to remaining an independent and dedicated CDMO. Our former CEO Prof. Dr. Nikolaus F. Rentschler continues to be actively involved in the company, serving as Chairman of the Supervisory Board. The organizational structure of the company is designed to allow efficient decision-making and rapid responses to changing industry dynamics, within the framework of a long-term perspective.</p>
<p>As a pure service player, Rentschler Biopharma can always provide the capacities required by our customers in a timely fashion. Our positioning as a dedicated CDMO differentiates us from competitors with mixed business models, because their proprietary development projects can compete for manufacturing capacity with their customers’ projects. Because we only act as an outsourcing provider, there are no capacity or priority issues for our customers.</p>
<p>Rentschler Biopharma’s end-to-end services cover the entire biopharmaceutical value chain from gene to vial and from clinic to market. We are highly specialized in mammalian cell culture and offer tailored approaches, including solutions for next-generation biopharmaceuticals designed to treat rare diseases. We seek to partner with our clients to optimally support their complex products and processes. Our goal is to establish long-term, win–win strategic relationships with our customers.</p>
<p>Overall, Rentschler Biopharma is a solution partner. We help customers take their ideas from genetic engineering all the way through fill and finish, with GMP production of both clinical and commercial quantities. Projects are supported by the elaboration of optimal global regulatory approval strategies from clinical studies to market approval, including the compilation of all required documentation (IMPD/IND CMC-Parts, Module 3 of BLA/NDA/MAA).</p>
<h4><span style="color: #0072bc"><img src="https://thatsnice-testing3.com/legacy/Q3%202018/PA_Q318_Rentschler_Sidebar1.jpg" alt="PA_Q318_Rentschler_Sidebar1" width="716" style="width: 716px"></span></h4>
<h4><span style="color: #0072bc"><br />Strategic Alliances Enable End-to-End Support</span></h4>
<p>To further support customers as a pure high-quality service player, Rentschler Biopharma has established a strategic alliance with formulation expert Leukocare and a strategic partnership with fill-finish provider Rentschler Fill Solutions.</p>
<p>Leukocare specializes in formulation technology and is the exclusive formulation developer for Rentschler Biopharma. We are the first and only CDMO to use Leukocare’s patented SPS<sup>®</sup> formulation technology (SPS<sup>®</sup> = Stabilizing and Protecting Solutions). SPS<sup>®</sup> technology especially improves the stability of antibodies at temperatures above the freezing point and even up to room temperature. This enhanced stability provides tremendous advantages in terms of production and purification, as well as storage, handling and transportation, reducing the need for a complex cold chain.</p>
<p>Customers in both Europe and North America have expressed interest in Rentschler Biopharma’s novel approach in leveraging Leukocare’s SPS<sup>®</sup> technology and are integrating customized solutions early in their development processes. In many cases, they are looking to replace standard formulations with features that extend the unique qualities of their molecules. Rentschler Biopharma is serving as a partner and advisor for these development programs and establishing an effective path for new biologics with first-in-class potential. These customers are realizing competitive advantages, shorter development timelines, cost savings and extended patent protections.</p>
<p>The partnership with Rentschler Fill Solutions provides access to a brand new, state-of-the-art fill-finish facility for the production of clinical and commercial biologic drug products, including liquid and lyophilized formulations. Rentschler Fill Solutions is the exclusive partner for Rentschler Biopharma’s fill-finish manufacturing projects. Importantly, Rentschler Fill Solutions operates under a quality system consistent with that of Rentschler Biopharma, which dramatically simplifies technology transfer.</p>
<p>In collaboration with Leukocare and Rentschler Fill Solutions, Rentschler Biopharma supports customers across the entire value chain for biopharmaceuticals.</p>
<h4><span style="color: #0072bc">Leveraging Key Trends for Customer Success </span></h4>
<p>Biologic drugs are clearly claiming an increasing share of the pharmaceutical market. Novel biomolecules are designed to attack new therapeutic targets and address unmet needs in new therapeutic areas: immuno-oncology drugs, personalized medicines and engineered antibodies are being developed to treat cancer, metabolic disorders, rare diseases and many other disorders.</p>
<p>These new modalities are also leading to the development of new manufacturing technologies and optimized processes. The yield of cell culture processes, for instance, has increased dramatically in the last five years, and future requirements for bioprocessing will undoubtedly be different than they are today.</p>
<div class="callout">
<h4 class="callout-title"><span style="color: #005891">In anticipation of the changing needs and to ensure that Rentschler Biopharma remains an innovator and leader in biopharmaceuticals, we have launched our Strategy 2025 initiative.</span></h4>
</div>
<h4><span style="color: #0072bc">Future-Oriented Strategies</span></h4>
<p>Through extensive in-depth discussions with clients and key opinion leaders, Rentschler Biopharma has been exploring the social megatrends that will impact our business. We are determining where we want to be as a company and how we can prepare Rentschler Biopharma for the future.</p>
<p>In anticipation of these changing needs and to ensure that Rentschler Biopharma remains an innovator and leader in biopharmaceuticals, we have launched our Strategy 2025 initiative. Strategy 2025 will address all aspects of our development and manufacturing activities, from the platform technologies we need, to how our people and facilities will operate in the future and what our customers will expect from a company like Rentschler Biopharma. The initiative is driven by innovation and seeks to reinforce Rentschler Biopharma’s position as a technology leader.</p>
<p>To do so, we will expand into regions where Rentschler Biopharma has not been very active in the past. We will also broaden our substantial knowledge of molecular entities into new biomolecules, such as bispecific antibodies and other new therapeutic modalities.</p>
<p>Collaboration with customers and other strategic partners will remain a fundamental aspect of our approach going forward. Close collaboration with customers facilitates the expedient development of tailored and optimized solutions. We will also continue to invest in added production capacities and capabilities to meet our customers’ growing demand as their projects move to late-stage clinical trials and commercialization. Through our Strategy 2025 initiative, we have identified the steps that must be taken to remain a global independent, family-owned and 100% dedicated CDMO offering flexible solutions and exceeding customer expectations.</p>

Dedicated CDMO Services Meet Customer Needs in the Dynamic Biopharma Sector