Outsource or Insource
Novasep has always operated a client-focused business model centered on individual project requirements. “Even during the early years when our technologies were centered on separations technology, our clients had the option of either outsourcing their projects to us, or asking us to develop the technologies for them to use in-house. This business model has been maintained throughout our evolution over the last 15 years.
“Today, we can take the development of a biopharmaceutical product from the earliest preclinical stage and provide process development and support up to late-stage clinical trials. We then still offer two options. Either we can carry out large-scale biomanufacturing for the client, or we can provide all the downstream technologies they require to carry out production themselves. We believe this ability to adapt to the client’s manufacturing strategy is unique in the market.”
Novasep’s strengths in engineering means it is ideally placed to respond rapidly to commercial-scale manufacturing requirements for any biopharmaceutical, Blehaut adds. “We are about to start our first commercial biomanufacturing contract, and our expertise in engineering and scale-up means we can rapidly set up commercial-scale facilities for clients as required.”
The company already operates six FDA-approved commercial-scale manufacturing facilities for synthetic APIs, and acquisition of Henogen has added two new biopharma facilities to its own commercial-scale biopharmaceutical plant.
“Our recent acquisition has, thus far, fulfilled all our requirements to become a full-service biopharma CMO,” Blehaut says. “Specific benefits include strong expertise in vaccines, and expertise in ADCs, which have given us rare expertise in the global marketplace. We aim to grow these offerings through partnerships with clients worldwide.”