Drug Substance Manufacturing

A Full-Service Supplier with a Broad Technology Portfolio

Richter-Helm BioLogics operates two multipurpose facilities for manufacturing biological drug substances with microbial expression systems.

Our services include technology transfer from external or internal process givers, performing engineering runs to validate processes, producing materials for clinical trials in early- and late-stage projects, carrying out QbD and/or conventional process validation to meet project requirements, and manufacturing high-quality materials for commercialization by our customers.

Also part of our portfolio are activities such as production of cell banks (MCBs and WCBs), storage of cell banks and bulk materials under controlled and qualified conditions, and filling of reference and stability materials and placebo buffers.

“We’ve become good friends while working together. Congratulations to all of the operators and managers at Richter-Helm BioLogics for doing such a great job!”

(customer)

Extensive Experience in Supporting Our Clients’ Success

With more than 25 years of experience and a vast number of completed projects, Richter-Helm BioLogics has at its disposal a wide range of equipment for biopharmaceuticals production (including methanol feeding devices for Pichia expression, preparative HPLC systems, and large refolding vessels). The manufacturing technologies used include enzymatic and chemical PEGylation, low-shear lysis, cell attenuation, and many others.

Richter-Helm BioLogics produces at scales up to a fermenter volume of 1500 liters and the corresponding downstream scales. Complete independence of USP and DSP in all facilities enables a high degree of flexibility for DSP volumes and sub-batching scenarios.

Our customer base includes large established pharmaceutical companies as well as start-ups. So far, four products from projects we have carried out have been commercialized worldwide, seven processes have been validated, and several more are currently undergoing phase III clinical trials.