Picture: Rentschler Biopharma

Rentschler Biopharma expands U.S. footprint

Prior to Danish Genmab A/S’s recent licence option deal with AbbVie Inc, Rentschler Biopharma has extended its collaboration with Genmab. European Biotechnology spoke with Rentschler Biopharma SE’s SVP Global BD Federico Pollano about the CDMO’s expertise in DuoBody® molecules production and the expansion of the CDMO’s U.S. production site in Milford.

EuroBiotech_What specific expertise does Rentschler Biopharma have in the development and production of bispecific antibodies?
Pollano_At Rentschler Biopharma, our strength lies in our proficiency with highly complex molecules. Our track record of 100 therapeutic protein formats, for a total of about 300 molecules, clearly reflects this expertise. We have almost 20 years of experience in the production of multispecific antibodies, including bispecific and trispecific antibodies. These account for close to one quarter of our development and production portfolio. This is no small feat, and we pride ourselves on the know-how and capabilities that we have developed for a range of formats, in bioprocess development and cGMP manufacturing, for our 150 clients worldwide.

EuroBiotech_How will Rentschler Bio­pharma support the clinical supply for client projects, as in the case of DuoBody® molecules for Genmab?
Pollano_Rentschler Biopharma offers an innovative, client-oriented business model that allows for the flexible allocation of resources in the clinical supply for our clients. The same model forms the basis of our strategic collaboration with Genmab, for the process development and manufacturing of bispecific antibodies generated with Genmab’s DuoBody® technology platform. This partnership represents a first-of-its-kind collaboration that will involve several novel projects and enable the client to decide in a flexible and agile way, which projects to advance and when. Hence, our clients benefit from the freedom to transfer a broad portfolio of products to Rentschler Biopharma
and then flexibly determine the course of their project based on clinical read-outs and management decisions.

EuroBiotech_What are the technical challenges in the production process of DuoBody® molecules ?
Pollano_The production of bispecific antibodies, like DuoBody® molecules, means combining two drugs to create one. When generating antibodies, problems posed by protein expression, stability issues or application of non-standard approaches can often lead to disappointing results. During processing or antibody purification, optimal yield strongly depends on precisely controlled reactions for complete heterodimer formation of the bispecific antibody. At the same time, unwanted reaction components must be efficiently eliminated whilst analytically monitoring and carefully characterizing the reaction steps.  The implementation of additional process steps within a fixed time window further increases the challenge with regards to the production of monoclonal antibodies.

EuroBiotech_What role does the new contract have within the U.S. expansion strategy of Rentschler Biopharma?
Pollano_ Our strategic collaboration with Genmab fits well with the expansion plans for our U.S. site in Milford, MA. The site is already taking on new projects, including complex and difficult-to-manufacture proteins. In total, Rentschler
Biopharma intends to continuously invest in site expansions to develop the site into a centre for excellence, offering multiple technologies and capabilities for numerous products. We also continue to hire additional people at the site, to keep pace with the site development and business growth. Expanding our global footprint and client centricity has been the key driver here.

EuroBiotech_What is the time schedule for the expansion of your Milford site, which was acquired last year?
Pollano_The first step in expanding
Rentschler Biopharma’s site in North America is a 500 L single-use bioreactor, which is operational now. The next step includes constructing another building for large-scale single-use manufacturing. We plan to leverage our expertise for client projects through every phase, be it early-stage development or clinical and commercial production. This will be achieved through site development and the hiring of additional people, as previously mentioned.

EuroBiotech_Does Rentschler Biopharma plan to produce there at an industrial scale?
Pollano_Yes, the expansion of our Milford site translates to a significant increase in our production capacity. Keeping current production, our project pipeline, and future expansion plans in mind, we can produce on clinical as well as commercial scales.

Federico Pollano is Senior Vice President of Global Business Development at Rentschler Biopharma, located in Laupheim, Germany. He has over 30 years of experience in pharmaceuticals and biopharmaceuticals, mainly in senior and executive positions at the following companies: Polpharma Biologics, Richter-Helm BioTec, Helm, BioGeneriX, Glaxo Wellcome, and Zambon. Pollano studied biology at Bielefeld University in Germany, and at the German Primate Centre, in Göttingen, Germany.

This Interview was published in the European Biotechnology Magazine Summer Edition 2020.