Saneca Pharma increases small scale API capabilities
CONTRACT development and manufacturing organization (CDMO) Saneca Pharma is strengthening its API capabilities to support client demand for smaller batch sizes and streamlined scale-up.
In collaboration with the Slovak Academy of Science, and with the support of European Union (EU) funding, the Slovakia-based CDMO is strengthening the infrastructure and expanding the suite of equipment within its API production units to reinforce the team’s expertise in opiate and synthetic drug development and production.
The announcement forms part of a collaboration between Saneca Pharma and the Slovak Academy of Science in which specialist lab equipment and infrastructure are combined with research and development (R&D) expertise.
The investment includes several smaller reactors that enable Saneca Pharma to deal with batches from approximately 1 to 30 kg in its new kilo lab. This lab then allows for scale-up and optimization activities that simulate the CDMO’s large scale production processes.
Anthony Sheehan, CEO at Saneca 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.”
“This is a very exciting time for our R&D team and this latest activity allows us, together with our partner, to explore and expand R&D activities. Such initiatives mean we can ultimately give clients greater flexibility at an earlier stage, while enabling their project to go from phase 3 development, to pilot plant, to commercial scale – all on the same site.”
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 on-site. 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.
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About Saneca Pharma
Based in Hlohovec, Slovakia, with close proximity to Vienna, Budapest and Prague, Saneca Pharma develops and manufactures a variety of finished dosage forms, with strong capabilities in solids and semi-solids and specialist expertise in the development of opiate APIs and final dosage forms from farm to pharmacy.
Saneca Pharma has a proud’ big pharma’ heritage and combines a strong track record of consistent supply and uncompromising quality, with a unique breadth of services, technical agility and dedicated experts to deliver responsive solutions.
For further information, please visit: www.saneca.com
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