Competent solutions for your research and development projects
Contract Research and Development
As we have extensive and long-term experience in both the preclinical and clinical development of cell based ATMPs, we offer this know-how and our laboratory capacities as services. In doing so, we draw on our broad network of experts, Contract Research Organizations and regulatory experts so that you are well prepared for communication with regulatory authorities.
ATMPs, like other medicinal products, must undergo the necessary preclinical tests (animal models and in vitro studies) before they can be used in human clinical studies. We would be happy to support you in conceptualizing your individual preclinical study portfolio in order to check the safety and effectiveness of your cell based ATMPs.
Our research & development laboratory also offers options for method and process developments, which, thanks to our many years of experience, are planned from the outset with the aim of cGMP implementation. In particular, we have experience in establishing cGMP manufacturing processes for adherent human cell cultures as well as analytical tests (viability, identity, potency, mycoplasmas). To develop methods and processes, we use our extensive cell culture and analysis equipment. We are happy to provide advice if possible or offer laboratory capacity for developing and validating your methods and processes.
We also have extensive experience in working with international Contract Research Organizations, doctors, and study centers in the field of clinical research and development. Implementing clinical trials with cell based ATMPs requires sufficient experience in particular to avoid possible pitfalls. We would be happy to advise your clinical research and development department with regard to special considerations that arise with cell based ATMPs.
ATMP production at the highest level
As a developer and manufacturer of human cell therapies, we have extensive experience in this area and its associated regulatory requirements. We offer this know-how and our production facility for contract manufacturing of ATMPs. Our production plant has rooms that fall within the pharmaceutical clean room classes A, B, C and D in an area of 460 m2 . In addition, we have 224 m2 available for research & development and quality control. Our controlled rate freezers and nitrogen tanks enable long-term storage of cells and tissue. Electronic monitoring of product and material flows as well as manufacturing processes contributes to our high quality standard. Our employees are qualified according to the function of a knowledgeable person (§7 Drugs Works Regulations, §15 Medicines Act), a responsible person (§9 Tissue Safety Act), a control laboratory manager (§9 Medicines Works Regulations, §70 Medicines Act) and a production manager (§8 Medicines Works Regulations, §69a Medicines Act). Our established quality management system contributes to compliance with all requirements.
We have certificates for isolation, aseptic production and storage of cell therapies from human tissues for clinical testing in accordance with the guidelines of Good Manufacturing Practice (GMP). In addition, according to the Tissue Safety Act, we are entitled to remove tissue (on site or remotely) and import it.
Our experienced logistics partners enable cells and tissues to be transported worldwide. Transport processes and their effects on the biological samples’ quality are controlled and validated by us.
Do you have a good idea for a cell therapy but not enough experience with the regulatory requirements? We can also advise and support you in taking the leap from an idea to GMP.
Contract analyses of ATMPs as well as microbiological tests
In order to guarantee the highest level of safety and the best quality of our cell therapies, we have established analytical control procedures for testing impurities and mycoplasmas as well as for quantifying our products’ biological activity. We offer our experience as well as our laboratory equipment for custom tests.
- Mycoplasma tests according to Pharm. Eur. Chapter 2.6.7:
- Cell indicator method
- Nucleic Acid Amplification Technique (NAT) using the PCR method
- Potency Assays: “Potency” is described as a measure of biological activity. Proof of this activity by means of a so-called potency assay is a prerequisite for releasing a cell therapy for clinical use. We have successfully developed a potency assay for quantitatively measuring the fusion of muscle cells. If possible, we would be happy to develop a potency assay for your individual ATMP or we can advise you during its development.
Due to the current COVID-19 crisis, we also offer a laboratory test for detecting SARS-CoV-2 using RT-PCR (Real-Time Polymerase Chain Reaction). Using this method, the viral genetic material can be specifically detected from smears. Samples are taken and diagnosed in collaboration with doctors. We are happy to receive inquiries from physicians.