Biopharmaceutical Research & Development Services
IBI offers services for the development, testing and manufacturing of pharmaceutical products (API and/or finished products), guaranteeing optimum results in terms of quality and realization times. The goal can be both the development of products for clinical trials and the manufacture of test batches for obtaining a marketing authorization or the transfer of production to your own premises.
IBI’s CDM division offers technologically avant-garde services for the manufacture of biological molecules, such as recombinant proteins and monoclonal antibodies, for formulation development (including innovative delivery systems such as lipid and polymer nano- and microparticles) and for analytical development; with skill, experience and flexibility, it scales up robust and reliable production processes, amongst which bulk and/or vial freeze-drying processes.
In agreement with the most recent guidelines and the most modern development methods, the CDM division adopts “Quality by Design” to optimize the production processes, characterize the critical parameters and support the documentation produced for the presentation of dossiers to the regulatory authorities. This approach is implemented through the application of DOE techniques. The collected data is processed for statistics using specific software, and risk assessment is performed during the scaling up and industrialization of the processes developed in the lab.
BIOLOGICAL API PROCESS DEVELOPMENT
CHO cell line development
Up- and downstream development and scaling up
Analytical characterization of biological active ingredients
Development of different types of formulations (oral, topical and injectable) for the manufacture of finished products (also biotechnological molecules)
Innovative delivery systems development
Microfluidic systems for nanoparticle preparation
Avant-garde tools for studying freeze-drying processes
Experience in technological transfer and industrial scaling up of production processes
Definition and testing of new analytical methods for small molecules and biotechnological products
Method optimization and/or transfer
Stability studies in accordance with ICH guidelines