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Sourcing Inquiry Logo Richter Helm BioTec

Richter Helm BioTec

Regions
Europe
Countries
Germany
Size
100-250
Specialty
Human Medicines, Biopharmaceuticals, …
Specialty
Human Medicines, Biopharmaceuticals, Generics
Service category
Contract manufacturing, filling and packaging, Formulation development and drug delivery
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Key services

Services


BioLogics portfolio

Thanks to our years of experience with protein expression systems, plasmid DNA technologies, downstream processes and cGMP manufacturing, we are in a position to offer our customers and business partners a first-class service from the development through to the production stage. Our development services comprise the cultivation of production strains suitable for manufacturing recombinant proteins and plasmid DNA as well as fermentation and downstream processes. In our state-of-the-art cGMP production facilities we set up cell banks (MCB and WCB) and produce biopharmaceuticals, both for clinical trials and market supplies.

Our production suites also include corresponding capacities for storing cell banks and active ingredients in compliance with cGMP requirements.

Contract development

We offer our customers a wide range of development services for recombinant proteins and plasmid DNA. Our Hamburg-based production plant features two identical 15 litre bioreactors plus the latest downstream processing equipment. There are three chromatography systems for the chromatographic purification of proteins and plasmid DNA, one of which can be operated at temperatures between 2°C and 8°C (36°F and 46°F).

Richter-Helm BioLogics can either launch a project from ‘scratch’ starting with the cultivation of an appropriate production strain or take over your project at a more advanced stage of development. We are happy to comply with your specific needs and pride ourselves on providing a tailor-made service geared to your particular project.

On completion of the development stage, the process is typically transferred to one of our cGMP production facilities, where it can be pursued on a larger scale.

Strain establishment

On request, we will be happy to conduct the optimisation, cloning and genetic manipulation of the gene to be expressed in our proprietary, inducible vector systems. We ascertain the optimum expression conditions by transforming various certified production strains and cultivating them in optimised media with no animal-derived components.

The ideally adapted ambient conditions for your protein/plasmid DNA then lead to the selection of the clones with maximum product yield. Following your instructions, we test the selected clones for functionality. The selected clones are expanded and cryo-preparations of the cells cultivated.

A precise, comprehensive documentation of the culture conditions and the selection procedure is forwarded to you in both electronic and written form.

Process development

We have years of experience with soluble and insoluble protein expression as well as the expression of plasmid DNA in E.coli and are happy to put this know-how at your disposal.

We offer you:

  • Process optimisation of existing processes
  • Development of scalable fermentation processes for cGMP manufacturing
  • Development and optimisation of high cell density fermentation processes
  • Development of refolding strategies for insoluble expressed proteins
  • Development of scalable downstream processes including chromatographic purification sequences

Analytical Development

Our analytical team works closely with the process development department in order to establish methods that make it possible to assess the process at different levels of development and judge the quality of the product at an early stage.

We provide the following services:

  • Bioassay development
  • Analytical studies to characterise proteins and plasmid DNA
  • Analytical development to determine ‘host cell proteins’ and ‘host DNA
  • Characterisation of reference standards
  • Formulation studies
  • Method validation conforming to ICH guidelines
  • Stability studies conforming to ICH guidelines

Contract manufacturing

Are you looking for a competent partner for the production of biopharmaceuticals in microbial systems or yeast strains? Putting the decades of experience we have accumulated in the production of recombinant proteins, plasmid DNA and vaccines at your disposal, we manufacture the products on your behalf in one of our ultra-modern production facilities.

We provide an all-round service for your project: from the development stage to carrying out toxicological and clinical studies, drawing up documents for submission to the regulatory agencies, manufacturing the active pharmaceutical ingredient through to the production of the drug itself.

Fermentation

Richter-Helm BioLogics has considerable expertise in cultivating E.coli and various yeast strains using both the batch and the fed-batch techniques. The capacity of our cGMP production facilities currently ranges between 15 and 1,500 litres. There are plans to increase capacity to 3,000 litres.

We have several different processes at our disposal for harvesting the cells, all of which can be aligned to specific product requirements.

Our production apparatus has been conceived and constructed strictly in accordance with the latest regulations. The bioreactors are housed in category D clean-rooms. Procedural steps involving biological materials are kept absolutely separate from non-biological sequences on a spatial, organisational and ventilation level.

Downstream processing

Richter-Helm BioLogics purifies recombinant proteins of various origins, from E.coli and yeast. Cell disruption, renaturisation and chromatographic purification processes are developed, optimised and scaled up to industrial level.

Numerous therapeutically effective proteins are stored in the form of insoluble inclusion bodies in expression systems of procaryotic origin. One of Richter-Helm BioLogics core competences is the in-vitro renaturisation of proteins from inclusion bodies on an industrial scale.

We also boast of expert know-how in the field of processing proteins which are secreted in (semi-)active form into the surrounding medium.

Apart from our competence in the production of proteins, we can also look back on more than 10 years’ experience in the processing of plasmid DNA.

Aseptic production

Our production plant in Bovenau has three separate category B clean-rooms, each of which is equipped with one or two sterile workbenches (LAF; class A). Every room has its own ventilation system and separate personnel and material sluices (air locks).

The production facility in Hanover has a category B clean-room containing a sterile workbench (class A).

It is under these ambient conditions, where strict levels of cleanliness are maintained in accordance with the guidelines for the sterile production of pharmaceuticals and active ingredients, that we create your master and working cell banks, produce the inoculum for the fermentation process and conduct sterile filtration and manual aseptic filling sequences in batches of up to 600 units.

Quality control

Our laboratories are equipped with state-of-the-art apparatus for analysing proteins and plasmid DNA and for determining biological activity. In addition, Richter-Helm BioLogics have also established various techniques for analysing product-specific and process-specific impurities.

In our quality control laboratories we test in-process control samples for monitoring and process steering purposes. We also analyse the active ingredients and pharmaceuticals that are produced as well as conducting the release procedure in accordance with the drug registration and administration laws, if the customer so desires.

On request, Richter-Helm BioLogics will validate analytical techniques and conduct stability tests in keeping with ICH guidelines.

Quality assurance

Quality assurance (QA) experts at Richter-Helm BioLogics keep an eye on internal standards and continually adjust them to progressive national and international demands. The quality assurance system is based on the cGMP requirements for the production of pharmaceuticals (EC guideline 91/356/EU on medicinal products for human use) and active components (ICH guideline Q7A for active pharmaceutical ingredients).

As an established, independent department, the quality assurance team is responsible for cGMP compliance at Richter-Helm BioLogics, conducting a cGMP audit and self-inspection programme in order to maintain standards as well as being involved in certain aspects of the qualification assessment of raw material suppliers, test laboratories or other service providers. Quality assurance itself is not only a regular target for external auditors commissioned by the authorities but also for auditors employed by international clients, so the experience gained from these audits is incorporated in the ongoing advancement of the QA system.

Quality assurance accompanies the product from its development through to the production and quality control, right up to the final release. Richter-Helm BioLogics’ quality assurance department is involved in issuing almost all documents dealing with manufacture and controls as well as conducting the so-called ‘batch record review’ in preparation for the release of the product.

Our QA system complies with the standards applicable in each case. However, it is normally possible to make adjustments to suit the needs of the customer concerned in order to support interdisciplinary collaboration and help the project unerringly on its way to success.


BioTec portfolio

Founded in 2008, Richter-Helm BioTec GmbH & Co. KG takes care of business development, marketing & sales and product development management of Richter-Helm BioLogics GmbH & Co. KG.

Marketing & Sales

Should you wish to find out more about our service spectrum, development capabilities and production capabilities, we at Richter-Helm BioTec are your first port-of-call and competent partner. In close collaboration between you and our experienced specialists, we develop solutions tailored to your particular needs.

Thanks to sustainable, reliable contractual commitments, our customers enjoy the safety standards required for their planning processes. Your developments are in good hands when you put your trust in Richter-Helm BioTec.

We stand for:

  • Integrated project management
  • Dependable time schedules
  • Transparent financial agreements

In-licensing/Out-licensing

Richter-Helm BioTec GmbH & Co. KG is responsible for the identification, evaluation and control of its own development projects right through to the licensed, finished pharmaceutical product. An experienced, competent team takes care of in-licensing and out-licensing. We are on the look-out for further, external development projects including, and in particular, those that are still in their early stages, with a view to adding them to our expanding product portfolio.

Licensing partners can be multinational corporations or even sales specialists operating on a national level. New perspectives, which may also serve to minimise financial development risks, can be opened up through the formation of development joint ventures. Thanks to our Group’s global presence, market potential can be exploited to the full. Richter-Helm BioTec views itself as the commonly missing link between the developers involved in research and the pharmaceutical firms specialising in marketing.

Our interdisciplinary, experienced teams cover all the core competences required for market research, patent evaluation, specification, pre-clinical and clinical development and the manufacturing of the finished pharmaceutical – right through to the licensing process.

Approvals, Certificates, Authorisations

  • cGMP
  • EU GMP

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