Our Passion

Our Passion

What unites us at Rentschler Biopharma, is the passion for what we do. We make a contribution to the global availability of biopharmaceuticals. As a full-service CDMO, we are your outsourcing partner for bioprocess development and cGMP manufacturing as well as for the elaboration of your products’ approval strategies from clinical studies to market approval. We guarantee best-fit solutions for your biopharmaceutical products by balancing timeline requirements with a comprehensive manufacturability assessment, with quality always paramount. This commitment is reflected in our outstanding regulatory track record as well as our exceptional client-oriented project management and regulatory support.

Emerged from a local pharmacy, founded in 1872, Rentschler Biopharma today is a family-owned and independent company. Our company structure guarantees rapid decision-making as well as efficient and smooth-running processes to adhere to project timelines. As a biotechnology pioneer, Rentschler Biopharma built a reputation through the early development of different interferon products (Fiblaferon, Polyferon).

Our Mission Statement

We, at Rentschler Biopharma, empower our clients to help patients with serious or rare diseases.

With our dedication and expertise, we convert medical research into outstanding biopharmaceuticals.

Our Objective

We are a leading contract development and manufacturing organization (CDMO), offering process development and manufacturing of biopharmaceuticals as well as related consulting activities, including project management and regulatory support.

Our Conviction

We make a significant contribution to biopharmaceutical production, thereby meeting the needs of emerging therapies and helping millions of people each day. We are among the best in the industry and set new standards in client focus, individual customized solutions and reliability. 

This is precisely what we stand for, and we are proud of it. Within just a few years, we have become an international CDMO in our field. Our conviction drives our performance both in the present and future.

Our Client Benefits

We seek to partner with our clients to exceed expectations and develop effective solutions, even for the most complex products and processes. Our client partners benefit from our continual investment in high-end technologies that increase efficiency and productivity to reduce time-to-clinic and market.

We are more than just a CDMO: We serve as a consultant, advising our clients and advocating for solutions that guarantee project success.

Management

Dr. Frank Mathias

Alexander Dettmer

Facts and Figures

Our Company

  • Independent, family-owned company in 5th generation
  • Chairman of the supervisory board is Prof. Dr. Nikolaus F. Rentschler
  • Headquartered in Laupheim, Germany
  • Site in Milford, MA, USA
  • Rentschler ATMP Ltd. in Stevenage, UK, focused on cell and gene therapies
  • Gross area: more than 43,000 m²
  • Biotechnology Pioneer
  • Full-service solutions, addressing clinical and commercial needs
  • Contract development and manufacturing of biopharmaceuticals in mammalian cell culture

Our Clients

  • We are the outsourcing partner for more than 150 clients worldwide
  • We work with small and big biotech companies as well as big pharma
  • Our clients include 17 of the world’s top 20 pharma companies
  • We work with approx. 40% of our clients for more than 5 years
  • Approx. 50% of our clients work with us on more than one project

Our Track Record

  • 50 years of experience in process development and manufacturing of biopharmaceuticals
  • Expertise with over 300 different molecules and over 110 different therapeutic protein formats
  • Deep understanding of international regulatory requirements, incl. special regulatory pathways (e.g. orphan drugs, biosimilars)
  • 49 international inspections in Laupheim, DE, since 2000
  • 2 FDA & 5 inspections of other authorities completed with zero findings in the last 3 years

Strategic Alliances

Leukocare AG

Rentschler Biopharma’s strategic alliance with Leukocare (Martinsried, DE) offers best-in-class formulation development considered at every step of the biopharmaceutical development and manufacturing process.

Operating at the interface of drug substance and drug product development, Leukocare combines profound knowhow in biopharmaceutical formulation development combined with innovative biostatistics and artificial intelligence (AI) expertise. By applying a maximum design space and specifically combining excipients in a DoE based approach, Leukocare is able to add value to the product. This leads to stabilizing formulations tailored to the product’s needs. Leukocare holds development laboratories and offices in Milford, MA, USA, located at Rentschler Biopharma´s Milford premises.

Strategic Alliances

Vetter

Rentschler Biopharma has a strategic collaboration with Vetter for high quality aseptic filling and secondary packaging. Together, the two CDMOs are mutually enhancing their services by offering complementary skills and experience along the biopharmaceutical value chain to enable clients to bring their products to patients more easily and faster.

Headquartered in Ravensburg, Germany, Vetter is a global leading contract development and manufacturing organization (CDMO) with production facilities in Germany, Austria 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.

Associations

Rentschler Biopharma is a member of the following associations

Quality and Sustainability

Quality and Sustainability

Quality is an overarching principle at Rentschler Biopharma. Irrespective of the stage of the project, whether in the consulting stage, in design, ready for implementation or during production of drug substance, the highest quality is our guiding principle.

Our drug substance manufacturing in state-of-the-art cGMP facilities meets the highest standards of the biopharmaceutical industry. To guarantee this, we follow high-quality standards within our internal processes and our team. Comprehensive quality management and precise, as well as reliable quality control, ensure excellent performance and results. We pay attention to the continuous monitoring and the adaptation of our quality standards.
Our ultimate goal is to empower you in bringing your product to market as quickly as possible, with the desired therapeutic effect, in the amount required and at the highest quality level.

Not only do we make the highest demands on the quality of our work, but also on our interaction with the environment. In our facilities, we not only focus on significantly reducing waste, but also on employing the most energy-efficient appliances. Since 2013, we also operate our very own combined heat and power plant (CHP) on our premises in Laupheim. This plant enables us to produce up to 75 % of our own power supply. Additional emergency generators allow us to be completely self-sufficient, if necessary. This ensures the security and continuity of our manufacturing processes at all times. The CHP provides sustainable and environmentally friendly heat and steam for our facilities, and as a result, we can reduce CO2 emissions by approximately 2,500 tons annually.

Milestones in Rentschler's History

1872

Our roots go back to the G. Müller Pharmacy in Laupheim

Our roots go back to the G. Müller Pharmacy in Laupheim

Our roots go back to the G. Müller Pharmacy in Laupheim

1927

Foundation as a pharmaceutical manufacturer

Foundation as a pharmaceutical manufacturer

Foundation as a pharmaceutical manufacturer

1974

Installation of the biotechnology division

Installation of the biotechnology division

Installation of the biotechnology division

1979

Start working with recombinant cell lines

Start working with recombinant cell lines

Start working with recombinant cell lines

1983

World´s first market approval for a natural Interferon-ß (Fiblaferon)

World´s first market approval for a natural Interferon-ß (Fiblaferon)

World´s first market approval for a natural Interferon-ß (Fiblaferon)

1989

Approval of a recombinant Interferon-y (Polyferon) and a topical Interferon-ß-gel

Approval of a recombinant Interferon-y (Polyferon) and a topical Interferon-ß-gel

Approval of a recombinant Interferon-y (Polyferon) and a topical Interferon-ß-gel

1997

Entering the business of contract development and manufacturing of biopharmaceuticals

Entering the business of contract development and manufacturing of biopharmaceuticals

Entering the business of contract development and manufacturing of biopharmaceuticals

2006

Foundation of Rentschler Biopharma Inc.

Foundation of Rentschler Biopharma Inc.

Foundation of Rentschler Biopharma Inc.

2008

Extension of manufacturing facilities (1 x 3,000 L stainless steel, 2 x 1,000 L single-use bioreactors)

Extension of manufacturing facilities (1 x 3,000 L stainless steel, 2 x 1,000 L single-use bioreactors)

Extension of manufacturing facilities (1 x 3,000 L stainless steel, 2 x 1,000 L single-use bioreactors)

2013

Implementing of own Combined Heat and Power plant

Implementing of own Combined Heat and Power plant

Implementing of own Combined Heat and Power plant

2014

Launch of proprietary cell line development platform TurboCell™

Launch of proprietary cell line development platform TurboCell™

Launch of proprietary cell line development platform TurboCell™

2015

Manufacturing starts in the first 2,000 L single-use bioreactor

Manufacturing starts in the first 2,000 L single-use bioreactor

Manufacturing starts in the first 2,000 L single-use bioreactor

2016

Expansion of manufacturing capacity
2x 3,000 L Twin facility, second 2,000 L single-use bioreactor

Expansion of manufacturing capacity2x 3,000 L Twin facility, second 2,000 L single-use bioreactor

Expansion of manufacturing capacity
2x 3,000 L Twin facility, second 2,000 L single-use bioreactor

2017

Alliance between Rentschler Biopharma and Leukocare
Rentschler Biopharma will acquire a 10 % stake in Leukocare

Alliance between Rentschler Biopharma and LeukocareRentschler Biopharma will acquire a 10 % stake in Leukocare

Alliance between Rentschler Biopharma and Leukocare
Rentschler Biopharma will acquire a 10 % stake in Leukocare

2019

Acquisition of site in Milford, MA, USA

Acquisition of site in Milford, MA, USA

Acquisition of site in Milford, MA, USA

2020

Strategic collaboration with Vetter

Strategic collaboration with Vetter

Strategic collaboration with Vetter

2020

Entry into mRNA Technology

Entry into mRNA Technology

Entry into mRNA Technology

2021

New Modalities and site in
Stevenage, UK

New Modalities and site in Stevenage, UK

New Modalities and site in
Stevenage, UK

2021

Capacity Expansion with 2,000-liter bioreactor

Capacity Expansion with 2,000-liter bioreactor

Capacity Expansion with 2,000-liter bioreactor

2021

Groundbreaking at new Rentschler Biopharma Manufacturing Center US, Milford, MA

Groundbreaking at new Rentschler Biopharma Manufacturing Center US, Milford, MA

Groundbreaking at new Rentschler Biopharma Manufacturing Center US, Milford, MA