Integrated Development and Manufacturing

An integrated team approach for process scale up includes process engineering, industrial pharmacy, analytical chemistry, microbiology, statistics, manufacturing and quality assurance and it is used from process design to process qualification.

Small batches to support Clinical Supply

Small batches for clinical supply or an intermediate scale up can be handled by using small equipment or disposable systems installed in small manufacturing areas that ensure small process losses and a short Transfer Time, by reducing scale-up risks.

Efficient Scale-Up Process

Laboratory and pilot scale models are designed to represent the commercial process. A few mg and several Kg of product can be handled by using the same technologies on a different scale.

Quality by Design

Thanks to an integrated team that includes experts from a variety of disciplines, facility and equipments were appropriately designed with an innovative approach that allows us to use Quality by Design starting from pharmaceutical development where the design space is defined throughout each product lifecycle stage including technology transfer and commercial manufacturing activities.

Intellectual Property Management

The outcome from product process development will be the exclusive property of the Client. BSP Pharmaceuticals ensures confidentiality and protection of Clients’ Intellectual Property.

Flexibility

The plant has been designed in order to sustain additional capacity or capabilities that may be required to meet Client expectations. All available space bound to expansion is already fully equipped with utilities and infrastructures.