BSP PHARMACEUTICALS, a CDMO TECHNOLOGICALLY DEVELOPED TO MEET THE NEEDS OF INNOVATORS, progress the MULTIMILLION € INVESTMENTS TO ADD MANUFACTURING CAPACITY FOR DS AND DP AND SPEEDS UP THE PLAN OF THE ONGOING EXPANSION FOR NON CYTOTOXIC PRODUCTS AT ITS LATINA, ITALY, SITE
High Potent and Cytotoxic
The expansion of the existing capacity for manufacturing High Potent and Cytotoxic compounds DS and DP is progressing according to plan.
This new multi-millions euros investment will consist of an expansion of approximately 30.000 sqf of the main building with the construction of new areas where an additional filling line for liquid/lyo vials and two additional conjugation areas will be installed.
The new filling line is planned to be in operation by second half of 2021 and will add sufficient capacity to produce up to 6.5 million vials annually under closed RABS technology to assure full containment and compliance to GMP requirements.
The two Conjugation suites will be available starting from the end of 2021 and each one will add capacity for more than 420 Kg mAb per annum.
This expansion will more than triplicate current capacity for DS manufacturing, for a total of 1254 Kg mAb per annum, and will offer the possibility to significantly scale up production’s batch sizes for increasing market demand.
The program for the ongoing expansion started in 2018 and aimed to open new capacity for Non-Cytotoxic products, has been speeded up and will be completed by 2023, three years in advance versus the original plan.
The project includes the installation of 6 filling lines, for liquid and lyophilized injectable products plus the implementation of all the ancillary services, including dedicated utilities, additional warehouse and new development laboratories.
The first two lines will be in operation starting from mid-2021 and the other four will be released within the following two years.
Starting capacity will be 12.7 million vials per annum and will be increased to 44.5 million by the end of 2023, when the full project will be completed.
The new facility will operate a world class, full-contained technology, and will be available for small and large molecules DP manufacturing.
This plant will handle IMMUNO-ONCOLOGY drugs (mAbs, checkpoint inhibitors, synthetic vaccines), IMMUNOTHERAPY drugs, as well as other INNOVATIVE products with the objective to continue supporting innovators in a wide range of therapeutic indications.
Commenting the news, Aldo Braca, President & CEO said: “Our goal is to elevate collaboration to strategic partnership, meeting customer’s needs without exposing them to inconvenient situations, maintaining a solid financial position that never compromises business continuity, paying great attention to the environment , health and safety on whatever we’re doing.
I hope this provides some clarity in the direction BSP is moving to and confirms our willingness to play an active role in supporting Pharmaceutical scientific community”
For more information, visit http://www.bsppharmaceuticals.com/