SERVICES

Scale Up and Manufacturing

Premas has multiple lines and suites dedicated to upstream and downstream processing technologies, including fully disposable single-use bioreactor systems. We are capable of meeting our customers’ demands on COGS, flexibility and productivity. Processes transferred from our PD labs seamlessly scale up in our large-scale GMP compliant facility. We have also successfully performed the validation and registration of several 2nd and 3rd generation processes.

Our 24/7 running mode of our processes enable us to design semi-continuous processes, simplified operations and significantly lower COGS processes. We developed different technologies and processes to offer significant advantages to a number of new molecule formats and manufacturing processes. Some of the benefits include a concomitant increase of productivity as well as simplified purification, along with low COGS.

Premas has the capacity to deliver grams to kgs product and drug substance. We have now for a particular product line expanded our capacity to 5kg/week delivery schedules.

This allows Premas to accelerate development of our customer’ product pipeline and enable critical deliveries for their clinical trials in various geographies. We have been audited by various regulatory and regulatory consultants and quality assurance groups of our customers.