The Nanofactory, which is well developed and has been expanded to include a second clean room, now guarantees coverage of the entire value chain from raw material and consumable control through manufacturing to the stable, sterile, injectable end product in accordance with the Good Manufacturing Practice (GMP) guidelines.
The new, larger Cleanroom II will be put into operation in 2021 after inspection and approval by Swissmedic. The Nanofactory is now designed for the production volumes required after market approval. Thanks to the multi-purpose design of InnoMedica's cleanrooms, they can be flexibly used for the production of different drugs in a modular fashion. They also leave the possibility open to manufacture future products from the pipeline.
Scale-up and automation
Thanks to lean processes and the modular infrastructure, scale-ups can also enable rapid capacity expansion in the future. In the course of scale-ups, investigations are carried out to determine which formulation and product adjustments are necessary in order to be able to produce the products in larger quantities. The expansion of the Nanofactory will not only ensure the production of the quantities required for clinical trials, but also for initial volumes upon market entry.
Important process steps from production to quality control and filling are now automated. For example, InnoMedica's own filling robots were developed for filling the end vials in collaboration with universities and industry partners. This approach was chosen because outsourcing is very expensive and the expertise generated in the process is ultimately not anchored within the company itself. Acquiring a standard solution in this area of automated filling is even more cost-intensive in the short term and is associated with long delivery times. Therefore, InnoMedica is investing in a cost- and time-efficient solution precisely tailored to the needs of the company and building up expertise in-house.
InnoMedica will continue to launch projects aimed at automating processes in the future. Further work is being done on optimizing the stability of the products in order to make the drugs last as long as possible, so that larger stocks and higher availability are possible.
Quality assurance
To ensure patient safety, InnoMedica relies on a well-functioning quality system. InnoMedica's quality management system is based on the requirements of Good Manufacturing Practice (GMP) and has been certified by Swissmedic. Internal GMP training courses have been established and are attended by all new employees. This raises awareness of quality-conscious work and the recognition of potential problems from the outset, while explaining internal quality procedures.
InnoMedica's quality control begins before manufacturing with qualifying equipment and incoming raw materials. Each batch produced is analyzed multiple times by the Quality Control and Analytics department: Samples are taken and checked in each case during the manufacturing process, at the end of production, and during storage. The Quality Assurance team then checks the GMP documents and subsequently releases the batches for use in the clinic. Under controlled conditions, the final filled vials with the drug are shipped to the various study sites and treatment centers in Switzerland.
Currently, InnoMedica's quality system is being expanded by gradually implementing the requirements of Good Clinical Practice (GCP). These guidelines ensure quality and guarantee the protection of patients in clinical trials. Compliance with these standards in the collection of clinical data from human subjects is essential for regulatory approval. In the first clinical trial, this was covered by the collaboration with the Swiss Association for Clinical Cancer Research (SAKK). However, closing the interface between GMP and GCP brings decisive advantages and makes InnoMedica independent with regard to study conduct.
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