We are a bioengineering company focused on the co-management of biotech projects. This service consists of offering the client comprehensive support far beyond traditional consulting services. During the duration of the project, we consider ourselves part of the client’s workforce and provide support even in the execution of start-up activities or in scale-up/engineering batches.
Our proven experience in project management for the construction and start-up of biopharmaceutical and biotechnological plants allows us to offer support to the client during the different phases of their project, from the drafting of the user requirements of the facilities to the start-up of the activity and the subsequent plant management.
Our team has extensive knowledge in bioprocess scaling up for different molecules and with very varied technologies. We have experience in different biotechnological processes such as fermentation, cell cultures with mammalian and human cells, enzymatic processes, etc. In terms of products, we have experience, among others, in the production of plasmids, therapeutic proteins, mABs, viral vectors, lcDNA, etc.
In addition, we contribute our experience in different regulated environments and EMEA (AEMPS) and FDA audits.