Delivering quality therapy since 1901

Biotechnology and CDMO services

Biotechnology is vital for a growing number of pharmaceutical companies worldwide. Gedeon Richter took a strategic decision to develop and produce Biopharmaceuticals: In 2007 we joined Helm AG to found Richter-Helm Biologics (Germany).  In 2008 we began a major project, to build a plant in Debrecen (Hungary).  Our world class facility was purpose built for developing and manufacturing biopharmaceutical products and enables other companies to share our resources, supporting their products from molecule to marketplace.

Drug Substance

Drug Product Facility

Support Services

Process Development

 

Drug Substance

  • Stainless Steel/SUB reactors: Our bioreactors are constructed from both stainless steel (medium to large volume) as well as the new SUT (Single use technology). Single use technology allows us to adapt the design of the main reactor quickly and cost effectively, enabling a faster and cheaper technology transfer. Having both of these technologies is a real advantage.
  • Fermentation capacity: 500L (SUB) 2000L (SUB) 5000L (Stainless Steel). For initial scale up batches we provide a 200L reactor. 2000L is the most popular batch scale in the CDMO market, supported with our brand new 4 x 2000L SUB's. Our 5000L reactors allow for larger volume commercial products. Once you start manufacturing drug substance at Debrecen, we have the capacity to meet your needs for the entire product lifespan.   
  • State of the art Automation (PAS): The Debrecen drug substance facility is home to the latest innovations in process control and technology. Use of process automation provides compliance, full control, reliability for every batch. This technology improves process repeatability and reduces the risk of error in complex processes.   
  • Flexible purification facility: The purification area has the ability to flex to any purification need required. 

 1.jpg

 

 Drug Product Facility

  • Syringe, cartridge & vial filling: Drug substance is filled into a range of different applications under sterile conditions.
  • Automated freeze drying: Our freeze drying technology allows the process to be recipe led and automatically charged/discharged, without human intervention. This reduces the risk of contamination.
  • Flexible batch sizes up to commercial scale (5L-500L): Filling products from development companies preparing their 1st products for clinical trial, up to fully commercial products supporting market demand.
  • Visual inspection and Label/Blister technology: Post filling, we inspect every vial/cartridge/syringe, ensuring that the product is free from any visual contamination. Post inspection, we add labels to the product and place it into a blister for transportation to the final pack assembly facility. 
  • Stainless steel/SUB available: We can use both stainless steel vessels and processes as well as more modern single use technology (SUT) materials (plastic bags/aseptic connectors). Our facility supports both technologies.
  • Restricted access barrier system (RABS): Filling processes are contained in a sterile environment. Open RABS are used for fast process changeovers (e.g. from vials to cartridges).

2.jpg 

     

Support Services

  • Full on site quality control (QC) testing: Quality control of our systems, processes and products is performed on site. Using state-of-the-art laboratory equipment, operated by a dedicated professional team, delivering results to the highest quality standards.
  • On site QA/Release: Products are released on site by our qualified person in full compliance with GxP rules and authority expectations.
  • Stability testing/storage:  Stability samples are stored and maintained on site under controlled conditions. Samples can be tested in house according to customer and authority specifications.
  • Quality control: Analytical, microbial and environmental monitoring services are available on site. 
  • EU GMP Compliant: Our facility meets cGMP guidelines, our systems ensure the health of consumers and patients.
  • 24/7 critical backup service: All key utility systems have backup services available 24/7. Our production facility's critical infrastructure is operated according to business continuity planning measures, to minimize the impacts of any supply events.

3.jpg 

Process Development

  • Development laboratory: State of the art facility became fully operational in February 2019 providing a high level of analytical support capabilities
  • Process development: We offer services from cell to drug product, using high throughput clone selection, scale down Microbioreactor capability, DS and DP process development and scale up.
  • Pilot plants for Drug Substance and Drug Product: Modern pilot facility equipped with the latest USP and DSP technology. Providing a range of scales allowing rapid and easy transfer to GMP facility. Our pilot plants are equally suited to troubleshooting and deviation investigations
  • Rapid tech transfers/scale up: Increased speed as a result of the pilot and commercial facilities both located on one site. Our staff have high level of tech transfer experience.  Our pilot equipment is aligned with our large scale facility.
  • Analytical Development: Extensive equipment options and wide range of expertise. Product characterisation and process analytic method development.
  • Ongoing development partnerships with academic institutions and universities:  New technology collaborations with leading academic institutions provide access to advanced technologies not available in house. These partnerships help maintain expertise of staff and awareness of the latest developments.

4.jpg 

 

We are looking forward to getting into contact with you. Please send us your information requests via email to: Contracts@Richter.hu