Rentschler Biopharma SE
Rentschler Biopharma SE is a family-owned full-service biopharmaceutical Contract Development and Manufacturing Organization (CDMO) and an experienced specialist for mammalian cell culture.
The company has core expertise in bioprocess development and manufacturing of recombinant proteins for clinical studies and market supply in compliance with international cGMP standards (EMA/FDA). Rentschler has expertise with a wide variety of substances such as monoclonal antibodies, fusion proteins, growth factors and enzymes.
The company’s clients include innovative biotech companies and major pharmaceutical companies around the world.
Many years of experience and excellence in finding solutions as well as certified quality management and advanced technologies ensure Rentschler’s high quality standards.
Products & Services
Rentschler Biopharma specializes in bioprocess development, cGMP manufacturing as well as professional consulting of their clients.
Main activities include:Cell line development
Offering comprehensive expertise in the development of high performance CHO cell lines for cGMP manufacturing. Based on target sequences or vectors, Rentschler can develop and establish stable cell lines and MCB or WCB cell banks.Process development
Developing, optimizing and validating of cell culture and purification processes. Rentschler works with time and cost-saving technology platforms to develop a tailored process for active ingredient as well as providing efficient process transfer.Formulation development
The Alliance of Rentschler and Leukocare offers contract development and manufacturing with proven excellence including best-in-class formulation that enables clients to realize the full medical and commercial potential of their products. Leukocare is the specialized technology partner and the exclusive formulation developer for Rentschler’s biopharmaceutical business.
Advanced formulation development is considered at every step of the manufacturing process to capitalize on the full product potential.
In addition to industrial standards advanced formulation development is performed based on the SPS® (Stabilizing and Protecting Solutions) formulation technology platform. The platform improves stability of therapeutic proteins in dry and liquid formulations, including highly concentrated products. The formulation development meets current and emerging demands in the increasingly competitive and cost-sensitive healthcare market.Analytical development
Developing, qualifying and validating of a wide variety of biopharmaceutical testing methods. With over 40 years of experience in the development of analytical methods, Rentschler is able to ensure the quality and purity of products according to all cGMP guidelines.Planning and project management
Optimal design of work packages for the respective development phases, professional initiation, execution and closing of projects, coordinated by a scientifically qualified project manager and with systematic monitoring of timelines, goals and budgets to provide project status updates and summaries.Regulatory support
Advice and assistance with regulatory questions, development of optimized strategies and generate the complete CMC documentation for approval (IND/IMPD CMC parts, Module 3 BLA/NDA/MAA).
Rentschler’s capabilities are based on deep expertise in a series of key processes and technologies. These include:
- Proprietary technology platform TurboCell™ that accelerates bioprocess development timelines
- Development of robust and reproducible processes directly scalable into manufacturing scale
- Cell culture processes in fed-batch & continuous (repeated batch, perfusion) mode
- Purification process platform with two or three chromatographic steps
- Single-use and stainless steel capabilities
- Protein modification including and PEGylation
- Advanced methods for biopharmaceutical testing parameters
Structure and history
Rentschler was founded in 1927 as pharmaceutical manufacturer in the city of Laupheim, in the southern German state of Baden Württemberg. It remains a family-owned company.
Rentschler moved into biotechnologies in the early 1970s, becoming a specialist in recombinant cell lines by the end of the decade. In 1983, it secured the world’s first market approval for a natural Interferon-ß (Fiblaferon), followed in 1989 by approval for recombinant Interferon-y (Polyferon) and a topical Interferon-ß-gel.
From the late 1990s, Rentschler became a contract developer and manufacturer of biopharmaceuticals, expanding to North America with the 2006 establishment of Rentschler, Inc.
Between 2008 and 2012, the company presided over a significant expansion of manufacturing capacity for installation of 3,000 L stainless steel bioreactor and two 1,000 L single-use bioreactors. Capacity was further expanded on 2015 and 2016 with addition of twin 3,000 L reactors and two 2,000 L single-use bioreactors.
In 2017, Rentschler forged a strategic Alliance with Munich-based formulation development specialist Leukocare AG.
To learn more about Rentschler’s services and capabilities and how they can assist your business, please contact the supplier.
- CRO, CMO, CRAMS & CDMO
- Clinical Trials & Studies
- Manufacturing & Production