Sartorius CellGenix GmbH

Name ›

Richter-Helm BioLogics GmbH & Co. KG

Suhrenkamp 59 22335 Hamburg Germany +49-40-55290-801 +49-40-55290-888 BusinessDevelopment@ richter-helm-biologics.eu www.richter-helm.eu

Address/P.O. Box › Postal Code/City › Country › Telephone › Fax › Email ›

Website › Social Media › Number of Employees › Founded (year) ›

I

~295 1987

Areas of Activity ›

Contract development and manufacturing of biopharmaceuticals derived from microbial systems

Biological Patents ›

Several patents on manufacture of recombinant proteins

External ›

Collaborations Richter-Helm is working with biotech and pharma companies worldwide

Request for ›

Further Collaborations Richter-Helm’s Business Development team will be pleased to learn more about your needs for development and GMP manufacturing services to bring your project one step further. For more detailed information please contact us.

GMP-compliant microbial production of biopharmaceuticals –Flexibility makes the difference

Richter-Helm is a successful and constantly growing Germany-based GMP-compliant contract manufacturer of biopharmaceuticals specialised in products derived from bacteria and yeasts.

Over the past 30 years Richter-Helm has gained substantial experience in the development and manufacture of a variety of product classes including therapeutic proteins and peptides, antibody formats (e.g. VHH), bacterial vaccines, and plasmid DNA (pDNA).

The company currently operates a development facility and two cGMP manufacturing facilities with bioreactor capacities of up to 1,500 litres. The addition of two highly flexible production trains with capacities of 300 and 1,500 litres and fully separated flows in a new facility building opens up capacity for new and further projects, enabling GMP manufacturing from phase I to III up to commercial supply.

With flexibility, commitment to good manufacturing practice, and total transparency our experienced, team offers highly specialised contract development and manufacturing services to support the global pharmaceutical and biotechnological industries.

With its solid experience and strong expertise in the field, Richter-Helm is the partner of choice for pDNA production and its supply in different grades and quantities, and for different applications. There is an established analytical platform specifically for pDNA products, including a generic and validated quality control testing approach.

Richter-Helm ensures the highest pharmaceutical quality standards, as verified by major regulatory bodies including EMA, FDA, PMDA, ANVISA, Health Canada, and MFDS as well as by numerous customer audits.

Products and services

The highly motivated and experienced teams at RichterHelm have excellent expertise in development and GMPcompliant production of biopharmaceuticals. To ensure efficient and transparent work, we apply professional project management methods.

Our process development team possesses extensive experience in developing and optimising fermentation and purification processes. For initial strain development, a variety of proprietary E. coli expression systems are available to support strain selection. Small-scale models of existing processes provide helpful tools for trouble shooting, process characterisation, and validation. Furthermore, small-scale models also ensure a smooth scale-up to large-scale GMP-compliant manufacture.

The quality system at Richter-Helm meets the strictest standards of quality in biopharmaceutical production. Our in-house quality control covers development and validation of a variety of analytical methods (incl. biological assays), performance of stability studies, and characterisation of reference standards.

Richter-Helm offers a full range of biopharmaceutical manufacturing services, including: › Establishment of cell banks (MCB/WCB) › GMP manufacturing for phases I to III › Commercial GMP manufacturing

Thanks to the broad knowledge of Richter-Helm’s experts and many years of experience gained from different kinds of projects, Richter-Helm works out tailor-made solutions for its worldwide customers, which include large pharmaceutical companies as well as advanced biotech companies. We treat each of our customers’ projects individually and with the highest flexibility – guaranteeing a successful partnership.