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Rentschler

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Rentschler

Identifying the most appropriate contract manufacturer who can best fulfil what you need for your lead pharmaceutical candidate is a real challenge. With over 40 years’ experience, Rentschler is one of the industry leaders for contract development and manufacturing.

For our clients, we lead projects to success according to their needs and timelines, which helps enhance their competitiveness. Delivering successful projects allows us to make an essential contribution to the global availability of biotechnological pharmaceuticals. Rentschler is an owner-managed, medium-sized company acting independently on a long-term basis.

Full-service concept

RentschlerOur full-service offering covers all activities from biopharmaceutical development through to manufacturing, analytical testing services and quality control to fill & finish.

Focused on mammalian cell lines, our experience covers the development and manufacturing of recombinant proteins such as monoclonal antibodies, fusion proteins, cytokines and enzymes in compliance with international GMP standards (EMA/FDA). Our many successful projects and long-term client relationships directly illustrate our experience and reliability.

Innovative technology

RentschlerRentschler’s proprietary TurboCell™ mammalian expression platform enables the simultaneous production of up to 20 early-stage drug candidate variants. The vector construction is based on site-directed integration of genes allowing the production of a reproducible and stable cell line. Specifically, this approach enables the fast supply of material within just six weeks (stable cell pools) or twelve weeks (clonal cell lines) to be used in early drug testing and pre-clinical studies.

Science-driven performance and cutting-edge technologies

Our success as a CDMO is underpinned by our focus on product quality, on-time delivery as well as comprehensive and tailored project management. This is further supported by the scientific strength of our team.

Rentschler employs cutting-edge technologies to ensure safe and stable cell culture and protein purification processes. Our state-of-the-art facilities and processes including batch, fed-batch, continuous and perfusion processing, allow us to manufacture material for clinical phases and commercial supplies. GMP certified suites with stainless steel bioreactors up to 3,000 L and single-use bioreactors with volumes of up to 2,000 L, support the flexible and customized cost-efficient manufacturing of material demanded by our global clients. In addition, Rentschler’s fill & finish facility offers aseptic liquid filling in vials, lyophilizates, and aseptic liquid filling of prefilled syringes.

Rentschler Rentschler

Expert guidance and solutions

RentschlerOur experience with international regulatory affairs and authorities allows us to maximize approval rates which can reduce not only the time-to-market but also support the overall success of the client’s project.

The Rentschler brand stands for expert guidance, long-term expertise, flexibility, innovation, and independence, all of which help deliver the right solutions for our clients and support the quickest time to market.

www.rentschler.de
marion.schrader@rentschler.de
+49 7392 701-0

Analytical Testing Services

We ensure safety, purity and stability of the product by comprehensive monitoring of all parameters affecting the product quality.

Analytical characterization of biopharmaceuticalsDrug product/drug substance release testingMethod validation and transferQualification and validation of raw and packaging materialsGeneration and characterization of reference materialStability studiesGMP complianceClick here for more information.

Aseptic Filling

Our experience with a broad range of substance classes allows individual solutions for challenging substances.

Formulation, filling and final finishingProduction of drug product for clinical supply100 % visual controlFDA & EMA inspectedFocus on therapeutic proteins and peptidesAseptic liquid filling in vials and pre-filled syringesLyophilization in vialsTwo lyophilizers (10 m² and 24m² space)Labeling and packaging for clinical studiesClick here for more information.

Bioprocess and Formulation Development

Rentschler delivers upstream process (USP) development for cell cultivation and downstream process (DSP) development for protein purification as well as formulation development.

Process development- Platform & customized- High cell density & high titer- Batch, fed-batch, continuous & perfusion- Non-GMP production up to 250 LScale-up and process transfer to production scaleProcess characterization, scale-down modelling and validationTransfer and optimization of client's bioprocessesLiquid formulation developmentPreliminary protein characterization including stress-degradationEvaluation of indicative analytical methodsParameter screening (pH, buffers, ionic strenghts, excipients, surfactants)

Cell Line Development

Rentschler provides comprehensive development expertise covering all stages of drug development in mammalian cell culture.

TurboCellTM mammalian expression platformEarly-stage candidate drug molecule screeningRobust CHO-K1 cell linesVector construction based on site-directed integration of genesMaterial supply within 6 weeks from pools, within 12 weeks from clonal cell linesAnimal component freeFor all types of recombinant proteins

Mammalian Cell Culture Manufacturing

In our cGMP certified facilities we manufacture biopharmaceuticals for clinical studies and commercial supplies. Multi-product facilities with stainless steel bioreactors lines up to 3,000 L and single-use bioreactors up to 2,000 L allow a high degree of flexibility.

Clinical and commercial drug substance manufacturingStainless steel and single use bioreactorsTechnology transfer and scale-up according to well-established protocolsProtein modificationState-of-the-art purification process capabilitiesViral clearance processesProduction, testing and storage of master and working cell banks
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