Collaboration in Action: New Milestones Efficiency and Simplifying the Complexities of Drug Development

Collaboration in Action: New Milestones Efficiency and Simplifying the Complexities of Drug Development

Jun 09, 2021PAO-06-21-CL-02-954

With mutual respect and a shared commitment to high quality standards and sustainable value creation, Vetter and Rentschler Biopharma began exploring ways to build upon our respective service portfolios and draw from synergies between our companies to provide valuable market foresight. In mid-2020, Vetter and Rentschler Biopharma announced a strategic collaboration aimed at achieving long-term value for clients through the alignment of manufacturing approaches, combining Vetter’s drug product manufacturing expertise with Rentschler Biopharma’s drug substance manufacturing expertise, to optimize time-to-market and simplify processes. The relationship allows Vetter and Rentschler Biopharma to leverage complementary skills and experience along the biopharmaceutical value chain, with the aim to better serve our clients and, by extension, their patients, more efficiently.

A Dynamic Global Market

The global pharmaceutical market and larger global healthcare ecosystem continue to experience rapid and expansive growth, albeit with increasing costs and complexities. Contract development and manufacturing organizations (CDMOs) must continually find new ways to better support their clients as they work to develop new therapies to treat patients with serious and rare diseases. In order to maintain safety and efficacy standards while simultaneously reducing costs and time to market, CDMOs must innovate while demonstrating flexibility and adaptability to maintain competitive advantages and provide first-class client service. Biopharmaceutical companies must streamline their products’ path to market and optimize efficiency and simplicity. To do so, CDMOs must think outside the box to set new standards and benchmarks as they continue to refine best practices. The collaborative alliance between Vetter and Rentschler Biopharma aims to mutually enhance our respective services to provide our clients and their patients with the best possible outcomes.

Defining and Refining — Progress in the Framework

Vetter and Rentschler Biopharma have marked an important milestone since the initial collaboration announcement, taking key steps forward to further strengthen and define our collaboration through validation of previously identified opportunities to simplify structures and processes, as well as sharing visibility into manufacturing requirements early on. This has led to an active exchange of best practices that may benefit both companies and our respective clients.

The alliance has progressed with the establishment of a governance structure in addition to the implementation of guidelines for a joint approach across functions. The framework for contributions from both organizations was established in a collaboration agreement, including operational agreements and guidelines between various departments spanning quality, development services, and logistics. These guidelines delineate key standards for joint approaches and core inputs, aligning interfaces and optimizing services for client convenience and long-term planning.

The formation of the mutual agreements and alignment on a client approach were foundational steps that both Vetter and Rentschler Biopharma identified early in our exploration of this strategic alliance. We look forward to the new progress that this step will facilitate.

Having more narrowly defined some of the finer details of the alliance, Vetter and Rentschler Biopharma anticipate the possibility of reduced project timelines, adding value to our respective clients and their patients around the world. Some of the joint measures include the orchestration of logistics processes to minimize efforts for active pharmaceutical ingredient (API) shipments, thereby reducing transportation risks. Additionally, joint organization and client-audit management should help coordinate a seamless exchange of information and client requests and the creation of an aligned client questionnaire for early information sharing. The collaboration is further enhanced through the coordination of processes and materials from Rentschler Biopharma on the drug substance side and Vetter on the drug product side. We have also been working to fast-track various options and boost technology concepts. 

Our efforts include collaboration across our business development teams, where we have clearly defined target markets with a focus on Europe, the United States, Asia-Pacific, and emerging markets. The teams are working closely to identify clients who would likely benefit from our collaboration, with each organization introducing the other to our respective clients to demonstrate the collaborative benefits. We have successfully initiated our first joint-client projects, with additional projects in various phases of discussion; however, each company will remain fully independent without an obligation for clients to work with both organizations.

“We are very interested to see how the experience gained in these initial projects will further enhance our strategic alliance,” commented Dr. Frank Mathias, CEO of Rentschler Biopharma. “These client engagements will provide valuable insights for our teams to leverage in refining the alignment of our processes and approaches.”

Both organizations remain steadfast in their commitment to simplify and accelerate product path-to-market for propitious new therapies for patients, and we will continue to pursue strategies and initiatives aimed at supporting the continued refinement of this collaboration.

About Vetter

Headquartered in Ravensburg, Germany, Vetter is a global leading CDMO with production facilities in Germany and the United States. Currently employing 5,500 individuals worldwide, the company has long-term experience in supporting biotechnology and pharmaceutical customers both large and small. Vetter services range from early-stage development support, including clinical manufacturing, to commercial supply and numerous packaging solutions for vials, syringes, and cartridges. As a leading solution provider, Vetter appreciates its responsibility to support the needs of its customers by developing devices that contribute to increased patient safety, convenience, and enhanced compliance. Great importance is also given to social responsibility, including environmental protection and sustainability.

About Rentschler Biopharma SE

Rentschler Biopharma is a leading CDMO focused exclusively on client projects. The company offers process development and manufacturing of biopharmaceuticals as well as related consulting activities, including project management and regulatory support. Rentschler Biopharma's high quality is proven by its long-standing experience and excellence as a solution partner for its clients. A high-level quality management system, a well-established operational excellence philosophy, and advanced technologies ensure product quality and productivity at each development and manufacturing step. In order to offer best-in-class formulation development along the biopharmaceutical value chain, the company has entered into a strategic alliance with Leukocare AG. Rentschler Biopharma is a family-owned company with about 1,000 employees headquartered in Laupheim, Germany, with a second site in Milford, MA. In Stevenage, UK, Rentschler Biopharma has launched a company dedicated to cell and gene therapies, Rentschler ATMP Ltd.