Developing and manufacturing microbial-derived biopharmaceutical products require deep expertise and reliable solutions that can guide a project to success while meeting evolving industry standards. To this end, pharmaceutical companies need expert partners capable of bringing promising cures to the market on time, regardless of scale.
Dr. Thilo Kamphausen
Director of Business Development
Dr. Kai Pohlmeyer
Richter-Helm, a leading biopharmaceutical contract development and manufacturing organization (CDMO) dedicated to providing best in class microbial development and production services focusing on plasmid DNA and antibody scaffold constructs.
“At Richter-Helm, we offer assistance across the microbialderived biopharmaceutical development and manufacturing value chain. Our true strength lies in late-stage projects, particularly in process validation, phase III assessments, and commercial launch preparation,” says Kai Pohlmeyer, managing director at RichterHelm BioLogics.
The company’s experienced process development team and cGMPcertified manufacturing facilities in Hannover and Bovenau, Germany, provide analytical and process development, strain generation, and GMP manufacturing. These competencies strengthen Richter-Helm’s ability to provide end-to-end solutions that ensure consistent transitions from early development to commercial production while adhering to the highest standards of pharmaceutical quality which has been verified by major regulatory bodies including EMA, FDA, PMDA, and more.
“We closely collaborate with clients, fostering a transparent, flexible relationship, or better: partnership. Our approach goes beyond the typical customer-service provider dynamic as we deliver holistic and seamless assistance throughout a project,” states Thilo Kamphausen, director of business development at Richter-Helm BioLogics. Constantly improving to meet the evolving demands of the biotech industry, Richter-Helm’s expertise extends to areas like cell line development, where it offers expertise in bioassay validation. In addition, the company’s flexible services enable clients to build customized packages for their needs, assisting them in overcoming the hurdles caused by the variability of microbial systems, scale-up limitations, and ineffective impurity removal.
Typically, early-stage projects aimed at rapidly developing phase I materials for clinical trials require larger-scale manufacturing and commercialization capabilities for phase III production. These cases create transitioning issues as the processes developed for phase I material production must be coherent and suitable for large-scale manufacturing and regulatory requirements of later stages.
Richter-Helm optimizes and adjusts process efficiency, scalability, and quality control measures to meet regulatory requirements and mitigate facility constraints before reintroducing a phase I-cleared product to phase III manufacturing.
“At Richter-Helm, we offer assistance across the microbial-derived biopharmaceutical development and manufacturing value chain. Our true strength lies in latestage projects, particularly in process validation, phase III assessments, and commercial launch preparation”
Internally, Richter-Helm nurtures close collaboration between its business development, project management, and key account management teams, allowing customers to access seasoned specialists across the three disciplines from the start.
In most cases, as the project progresses, its business development / key account management team remains engaged, offering support in addressing emerging non-technical issues. In contrast, the project management team focuses on the technical aspects, ensuring efficient and timely execution of critical tasks. Recently, Richter-Helm assisted a customer that faced a regulatory issue in Europe when one of the components in their process was banned from use. For this project, the company swiftly replaced the prohibited compound with an appropriate substitute, ensuring the process remained effective and the quality uncompromised. Ultimately, its ability to navigate unexpected situations assisted this customer to achieve desired outcomes.
Driven by its unmatched expertise and adaptability, RichterHelm is a trusted problem solver, empowering pharmaceutical companies to reliably develop strong and validated processes for their microbial-derived biopharma products.