New leadership telegraphs strategy with Leukocare technology deal.

Biotechnology CDMOs are gearing up to compete for an increasing share of a growing market for therapeutic biologics, a market that Visiongain predicted will be worth $248.2 billion by 2020. Recent announcements by Rentschler Biotechnologie are revealing, telegraphing its strategy to compete more aggressively for more business from this dynamic pharma sector.

 Effective last spring, Dr. Frank Mathias was appointed as Rentschler’s CEO. An experienced biotech leader, Mathias’ 25 years’ experience began as Product Manager at Hoechst AG. From this point, his career advanced with Mathias gaining executive experience, helping manage some of the sector’s most prominent biopharmaceutical companies including the Germany-based business units of Servier and Amgen. By 2009 he was CEO of Medigene AG, which concentrates on developing personalized T cell-based immunotherapies and complementary treatment platforms to target various types and stages of cancer. Innovation in biotechnology is critical, but experience is even more so, and many viewed the appointment as positive, including owner and family member Nikolaus F. Rentschler who remarked, “We are glad to have been able to take on such an experienced and successful CEO… He is an expert in this business and has been familiar with the company’s topics for years.”

Rentschler, a German family-owned business since 1927, ranks itself among the world´s leading biopharmaceutical CDMOs. With a track record of delivering successful consulting, bioprocess development and manufacturing solutions, its experience spans some 200 different molecules and more than 250 API batches. It’s also a bioprocess innovator, employing continuous manufacturing methods to ingredient manufacturing to about 30% of the company’s cell culture processes.

An indicator of the strategic direction Mathias is taking the company was revealed in February, when he publicized a strategic alliance with Leukocare AG, Martinsried. The deal provides Rentschler exclusive access to Leukocare's patented SPS^® formulation technologies. Leukocare provides formulation development services based on its proprietary SPS^® (Stabilizing and Protecting Solutions) technology platform, which has been shown to significantly improve the stability and quality of biologics like antibodies, vaccines, etc. in dry and liquid formulation therapeutic proteins.

The ability to mass produce therapeutic molecules effectively hinges on a processor’s ability to maintain processing conditions within limits the molecule can tolerate. Controlling these parameters can be difficult depending on the molecule and Leukocare’s SPS, for example, can help liquid dose biopharmaceutical formulations achieve better stability at higher temperatures and with a longer shelf life — a distinct competitive advantage that supports high-throughput process and improves the ability to maintain the drug’s therapeutic effectiveness in the field with fewer cold chain logistic and storage complications. According to Leukocare, the patented SPS^® platform is characterized by specific and innovative combinations of regulatory established and employed excipients. 

Rentschler says the Leukocare alliance aims to strategically incorporate formulation development at every step throughout biopharmaceutical development and manufacturing. "Our alliance brings to the forefront the importance of drug formulation as a key success factor in the development process,” said Mathias. “We believe our enhanced ability to improve formulations will result in value creation for our clients and ultimately also help doctors and patients." 

Michael Scholl, CEO of Leukocare, offered similar sentiments regarding the relationship. "With a strong partner like Rentschler, we will be able to offer our innovative formulation expertise to a broad range of clients and elevate the role of formulation strategy on the biopharmaceutical industry's agenda." 

Under the agreement, Leukocare becomes a specialized technology partner and formulation developer, with Rentschler being the first CDMO to gain access to Leukocare’s ongoing and future business activities. According to Rentschler, regarding pharma, biotech and beyond, its CDMO business won’t be affected by the alliance. Under the deal’s terms, Rentschler acquired a 10% stake and Mathias joined Leukocare's board of directors.