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Biopharmaceutical Development and GMP Manufacturing: Preclinical to Commercial Supply August 2016

Kai Pohlmeyer

August 10, 2016

2 Min Read

11-7-R-Helm-LOGO-300x152.jpgRichter-Helm is a Hamburg, Germany–based contract development and manufacturing company with a proven 25-year track record, specialized in products derived from bacteria and yeasts. Count on us to flexibly provide a comprehensive range of services and customized solutions. Clients worldwide already have benefited from our commitment to good manufacturing practice (GMP) and total transparency. Our work focuses on recombinant proteins, plasmid DNA, antibody fragments, and vaccines.

Richter_Helm_Arbeitssituation2_0264_mod_CMYK-200x300.jpgOur seasoned, 160-strong team supports you with process development, supply of products for clinical trials, commercial production, in-house quality control (QC) testing, and QP release. We operate two GMP-compliant production plants with bioreactor capacities of up to 1,500 L.

Richter-Helm consistently works to the highest standards of pharmaceutical quality, as verified by major regulatory bodies (European Medicines Agency (EMA), the US Food and Drug Administration (US FDA), Agência Nacional de Vigilância Sanitária (ANVISA), and Ministry of Food and Drug Safety (MFDS)) and by numerous customer audits.

Products and Services
Our large equipment fleet in development and production and extensive experience with many product types (including recombinant proteins, antibody fragments, pDNA, and vaccines) enable us to flexibly meet our clients’ needs. Early introduction of analytical testing procedures is another prerequisite for high-quality processes and an important cornerstone of Richter-Helm’s services.

To ensure efficient, transparent work, we apply professional project management methods based on international standards. Richter-Helm offers a full range of biopharmaceutical service to its customers, including

  • Strain development (e.g., Escherichia coli, Pichia pastoris)

  • Optimization of expression systems

  • Establishment of cell banks (master cell bank (MCB) and working cell bank (WCB))

  • Process development (upstream and downstream)

  • Development and validation of analytical methods (including biological assays)

  • In-house QC testing and release

  • GMP manufacturing for clinical phase 1–3

  • Commercial GMP manufacturing

  • Process validation

  • Stability studies according to the ICH.

Quality Comes First
The quality system implemented at Richter-Helm upholds the strictest standards of quality in biopharmaceutical production. Various inspections and audits have confirmed that it meets the cGMP requirements of leading regulatory bodies. Our thoughts and actions are guided by the concept and approach described in a detailed quality manual.

Dr. Kai Pohlmeyer is vice president business development at Richter-Helm, 49-40-55290-436; [email protected].

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