Novasep (Lyon, France) has announced a €6 million investment of its Chasse-sur-Rhône site, in Lyon, France. This investment will increase and modernize its manufacturing capabilities to support new generation active pharmaceutical ingredients (APIs), in areas such as oncology, central nervous system (CNS), and infectious diseases.
Continuous, or flow chemistry, is a growing area of importance in API manufacturing, offering advantages such as improved productivity, reduced energy and solvent consumption, better reaction control, increased process safety, and reduced exposure for personnel over traditional batch chemistry.
Novasep has invested heavily into flow chemistry since the establishment of a research platform at the Chasse-sur-Rhône site in 2013. This latest investment sees the installation of a cGMP flow reactor, and strengthens the site’s ability to develop methods for efficient process development under continuous flow conditions.
“The addition of a cGMP flow capability at manufacturing scale, a technology which Novasep has been working on for several years in R&D, is an important step forward to strengthen our competitiveness in the active pharmaceutical ingredients market,” said Catherine Vindevoghel, Site Director of Chasse-sur-Rhône.
“We are proud of this investment, which will increase employment opportunities in France whilst improving responsiveness and reinforcing manufacturing capacities for essential therapeutic drugs for our customers, and ultimately for patients,” continued Vindevoghel.
In parallel, Novasep continues to reinforce its capabilities on the site for low to medium volume APIs, in response to increased customer demand (through the debottlenecking of drying and purification capacities, and the addition of a new clean room). These investments will enable Novasep to accommodate customers’ growing needs for outsourced API manufacturing services, increasing flexibility, reinforcing state‑of‑the‑art technologies, and strengthening its competitiveness.
The investment project was also selected and supported by the French government as part of the “France Relance” recovery plan. The programme rewards innovative and promising industrial investments in France, with the aim of reinforcing production capabilities of APIs for essential therapies, increasing economic growth and boosting employment.
For more information, please visit: www.novasep.com
AI and GenAI Applications to Help Optimize Purification and Yield of Antibodies From Plasma
October 31st 2024Deriving antibodies from plasma products involves several steps, typically starting from the collection of plasma and ending with the purification of the desired antibodies. These are: plasma collection; plasma pooling; fractionation; antibody purification; concentration and formulation; quality control; and packaging and storage. This process results in a purified antibody product that can be used for therapeutic purposes, diagnostic tests, or research. Each step is critical to ensure the safety, efficacy, and quality of the final product. Applications of AI/GenAI in many of these steps can significantly help in the optimization of purification and yield of the desired antibodies. Some specific use-cases are: selecting and optimizing plasma units for optimized plasma pooling; GenAI solution for enterprise search on internal knowledge portal; analysing and optimizing production batch profitability, inventory, yields; monitoring production batch key performance indicators for outlier identification; monitoring production equipment to predict maintenance events; and reducing quality control laboratory testing turnaround time.
Investigating Synthetic Cathinone Positional Isomers using LC–EAD-MS
November 7th 2024Peng Che fom Vrije Universiteit Amsterdam in the Netherlands discusses the benefits of hyphenating liquid chromatography (LC) with electron activated dissociation mass spectrometry (EAD-MS) to analyze cathinone positional isomers.