Contract development and manufacturing organization (CDMO) Saneca Pharma is investing heavily in its API capabilities to support client demand for smaller batch sizes and streamlined scale-up.
The Slovakia-based company is strengthening its infrastructure and expanding its suite of equipment within its five API production units to reinforce its expertise in opiate and synthetic drug development and production.
This investment includes several smaller reactors that enable Saneca Pharma to now deal with batches from approximately 1 to 30 kg in its new kilo lab. This lab then allows for scale-up and optimisation activities that simulate the CDMO’s large scale production processes.
Anthony Sheehan, CEO at Seneca Pharma, said: “This investment into new equipment at our site gives us much greater flexibility in supporting clients with development projects. It also gives companies the option to tech-transfer products in at an earlier stage. As our R&D operations are integrated with our API manufacturing facilities and our finished dosage form production capabilities, we can offer clients an end-to-end service and a very efficient and cost-effective process all from one location in Slovakia.”
“This is a very exciting time for our business and this latest investment allows us to cater for development on demand. This ultimately gives clients greater flexibility at an earlier stage, while enabling their project to go from Phase III development, to pilot plant, to commercial scale — all on the same site,” he added.
Operating from a site that has manufactured APIs since 1941, Saneca Pharma has a strong track record in developing and manufacturing synthetic and bio-mass APIs, especially controlled substances based on morphine and other poppy straw alkaloids.
With a dedicated morphine production unit, Saneca Pharma has specialist expertise in opiate API manufacturing, with full supply chain integration from raw materials to oral and semi-solid finished dosage forms.
The growing European CDMO currently manufactures over 30 different APIs onsite. To simplify the transfer of client projects from pilot to commercial scale, its team uses the same equipment in the API development and manufacturing facilities.