Novasep, a service provider for the life sciences industry, has signed an agreement with biopharmaceutical company Paratek Pharmaceuticals have signed an agreement to ramp up the commercial production of omadacycline. The API is used in Nuzyra, an FDA-approved antibiotic for adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections.
The agreement is the result of a partnership started in 2016 with technical transfer and process development at Novasep’s Pennsylvania site. The process was then transferred to the company’s Chasse-sur-Rhône facility in France for further scale-up, validation & cGMP manufacturing, using its large scale HPLC chromatography and synthesis capabilities. While production will continue at Chasse-sur-Rhône, the final step of the process will be conducted at Novasep’s German site in 2023, addressing increased volume requirements.
“This deal marks a real recognition of the long-time expertise of the Novasep teams in the production of complex APIs, demonstrating the strength of our process development and the integration of specialist purification technologies such as HPLC chromatography,” said Jean Bléhaut, President of the Pharma Solutions Business Unit at Novasep. “We would like to thank Paratek for their support and trust throughout this project; we are proud to support them in delivering such an innovative drug to fight against the antimicrobial resistance for the benefit of patients.”
“This long-term agreement with Novasep in our existing supply chain helps ensure that Paratek can continue to confidently supply Nuzyra to meet the needs of patients and healthcare providers, fulfill our commitments to BARDA, and explore further opportunities to provide an innovative solution to the antimicrobial resistance crisis,” said Randy Brenner, Paratek’s Chief Development and Regulatory Officer. “We are grateful to our colleagues at Novasep for their continued partnership in manufacturing high quality API and securing our supply chain.”