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 two multiproduct GMP facilities are run by highly motivated and experienced teams. A proven technology transfer approach lets us smoothly adopt and implement processes from our clients or our own process development department.

We regularly and successfully use defined procedures to scale production up and down as required. To ensure efficient, transparent work, we apply professional project management methods based on international standards. Our large equipment fleet and extensive experience with many product types (including recombinant proteins, antibody fragments, pDNA, and vaccines) enable us to very flexibly meet your needs.

As a biopharmaceutical manufacturer with more than 30 years of experience, we are keenly aware of our responsibility to patients.

The rigorous quality system that we have implemented at Richter-Helm BioLogics ensures the highest standards of quality in biopharmaceutical production. Multiple inspections and audits have confirmed that it meets the cGMP requirements of leading regulatory bodies. In addition, a detailed quality manual guides our actions every step of the way.

Our Quality Assurance at a glance.

Solutions for meeting Large-Scale Needs

Richter-Helm BioLogics possesses extensive experience in developing and optimizing processes for producing recombinant proteins, plasmid DNA, and vaccines.

Our focus is on E. coli and Pichia production technology. Whether the starting point is the cDNA sequence of your target molecule or a preliminary small-scale process, we reliably carry your project to fruition by implementing large-scale, GMP-compliant manufacture. Interdisciplinary teams comprising experts on process development, analytics, and large-volume production ensure smooth scale-up. Small-scale process characterization and validation support round out our capabilities.

We make available our considerable expertise on developing strains based on E. coli host systems to produce peptides, proteins (soluble and insoluble), plasmid DNA products, and vaccines. The USP development capabilities at Richter-Helm BioLogics include the full range of leading-edge fermentation strategies for batch and fed-batch concepts based on microbial hosts like E. coli and yeast.

Downstream Process Development Services

We can adjust and fine-tune the steps of downstream process development to meet your needs. This includes complete DSP development from scratch and/or DSP adaptation and optimization studies.

Process characterization is essential for generating detailed knowledge and in-depth understanding of products and processes.

Know Your Molecule

Analytical testing methods are crucial for successfully developing biopharmaceuticals. Early introduction of them is a prerequisite for high-quality processes.

Our QC testing meets all of the requirements of our clients and regulatory bodies.

Continual improvement of methods and fit-for-purpose validation approaches are also essential in order for QC testing of biological molecules to meet all of the requirements of our clients and regulatory bodies. We employ analytical methods for in-process control, release testing, and characterization of recombinant proteins, plasmid DNA, and vaccines.

We have over 40 highly qualified and motivated professionals (more than half of which have university degrees) ready to identify and apply the best solutions for your project. You can also count on a whole battery of GMP-compliant quality control measures:

• Method transfer or implementation
• Validation of analytical procedures according to ICH and USP
• Lifecycle management of your methods
• Adaption of platform-based methods to your product
• Verification of compendial procedures
• In-process and release testing of intermediates, drug substances and drug products
• Comparability testing
• ICH conform stability testing
• Testing of raw materials and facility supply
• Characterization of cell banks

Development Services

Analytical development at Richter-Helm BioLogics is set up to establish state-of-the-art, fully compliant solutions for your molecule.

Our on-site GMP laboratories uphold the highest standards of quality as required by EMA, FDA, ANVISA, etc.