What kind of services do Biologici Italia Laboratories offer and how are they proposed?
Like the other companies of the Group, Italy Biological Laboratories offer their customers full-service contract manufacturing in their field of activity, which is the production and packaging, in vials and bottles, of sterile injectable products in both liquid and lyophilized form. Masate’s production centre, active since 1967 and renovated for several times, is located on a total area of 28,906 square meters, with a large flexibility and capacity production, and in details there are 6 lyophilization units, with total lyophilization area of about 200 square meters. Offered services run from APIs purchase management, excipients and packaging materials, up to production and primary and secondary packaging, analytical control and release. Flexible and modular according to customer’s requirements, the service may stop at finished product in bulk (vials and bottles) or up to the secondary packaging. In this case, Biologici Italia Laboratories can ensure compliance with the traceability regulations used in Italy, France and other European countries.
Can we trace a complete supplying process?
There are four phases: assessment, preparation, implementation, industrialization. During the assessment phase, after signing the confidentiality agreement with the potential customer and after receiving the necessary technical documentation, we have a team that analyzes the project’s technical feasibility (equipment adequacy) and possible problems (risk analysis). Technical analysis leads to a production note which is the basis for the issue of the final offer to be sent to the potential customer. Once the economic agreement is reached, a supply agreement is signed and the preparation stage begins, in which QA and R & D, after the first customer order, prepare the necessary documents for validation of production processes and analytical methods. If necessary, in case of insufficient technical documentation, some laboratory pilot lots are prepared in order to perfect the production method. The next step is the production of assessing lots and the issue of related CoA to be sent to the customer for the start of change procedure. Meanwhile, the respective QP’s have signed a Technical Agreement to define their responsibilities. The final step is the implementation stage: having the authorization by the competent Authority as production site for the requested product, final lots are packaged and delivered to the customer together with GMP Statement. Now the product can be launched on the drug market beginning its industrialization. Once an order comes in, the Planning schedule will organize the different stages (raw materials purchase, production lines in use) in order to be able to deliver and release the order according to the terms by the Supply Agreement.
How do you imagine the development and prospects of contract manufacturing services?
I think nowadays there is a very positive market trend towards contract manufacturing in Italy and abroad. In the pharmaceutical sector we are experiencing an evolution towards an advanced outsourcing concept which is very similar to an integrated partnership in projects of multinational companies, where it is important to ensure high quality services, enhanced by professional and highly qualified functions. In Italy there are lots of manufacturers for third parties and they represent an important industrial heritage for the Country, as they generate linked activities in the area, and they should be even more enhanced at all levels, including the institutional one. In this field Made in Italy is guarantee of high quality and reliability with technological and production know-how that is widely recognized and appreciated internationally. Corvette Group is a leading player in this scenario; it aims at expanding the range of offered services, also through the acquisition of other companies, with the same highly qualified and distinctive technological and manufacturing characteristics as the other already acquired companies.