BSP is a Contract Development and Manufacturing Organization focused on production of anticancer and cytotoxic drugs as small molecule products and more innovative drugs, like proteasome inhibitors, ADCs (conjugation and fill/finishing), lipid-based formulations (nano and micro-emulsions, liposomal formulations), from Development to Clinical and Commercial Supply.
The laboratories for formulations and process development are conveniently situated in the production area of the plant. Our specialists have the knowledge and training on the plant equipment and production requirements to reduce the risks of scale up failure.
BSP OFFERS A HIGH LEVEL OF EXPERTISE TO SUPPORT THE MANUFACTURING OF CLINICAL PRODUCTS FROM PHASE I TO PHASE III.
The versatility of our plants allows us to easily transfer processes that are suitable for scale-up and scale-down on automated equipment.
THE PROCESS ROBUSTNESS AND THE ACCURACY OF A TECHNOLOGY TRANSFER ARE THE BASIS FOR A HIGH QUALITY PRODUCT.
The Client can choose from a vast range of dosages: from the conventional pharmaceutical form in lyophilized vials, vials with aseptic liquid filling and final sterilization upon request, tablets and capsules, to the high technology pharmaceutical dosage form, like the liquid filled hard gelatine capsules with the ADC (conjugation and fill/finish) products, the lipid based and biological solvent based formulations.
The objective of BSP is to deliver results that meet the requirements of global regulatory health authorities.
The facility houses chemical, biochemical and microbiological laboratories for the following typologies of analyses:
The Quality Control chemical lab supports the cGMP manufacturing of Clinical and Commercial anticancer drug products
with the following activities:
A wide range of analytical instruments enables the laboratory to run tests such as:
Stability and photostability studies are performed according to ich conditions:
Providing assays suitable for regulatory submission aligned with several regulatory agency requirements and equipped to
carry out tests, such as:
Our microbiological laboratory supports the following testing:
The biochemical laboratory has experience in establishing, validating and conducting routine bioassays according to cGMP standards.
Fully validated assays suitable for regulatory submission are provided.
Characterization work includes the determination of physicochemical and structural properties, purity, impurities and quantity of the monoclonal antibody, in line with ICH Q6B.
The main services offer comprises: