Production Plant
Difference between our two production plants
The two plants are characterized by different processes. Small molecules-based production is executed through well-established cycles: weighing, granulation or preparation, and then packaging and the focus of production is on the optimization of production efficiency. The speed of production in this plant is rapid. For instance, for one batch of our Oki sachets product, (25,000 boxes) it takes 8 hours to weigh, 8 hours to granulate, and about 15 hours to package. The result is that one box of Oki per second is produced by our team.
Biotech production is characterized by extremely specific process and cycles for each substance, and the focus is on the process itself which is generally divided in Upstream and Downstream. In the Upstream phase, biotech process use living microorganism to produce products which are further purified in the downstream phase. Microorganisms are grown on fermenters (or bioreactors) that provide the right environmental conditions to produce the product. Furthermore, in this plant, biotechnologists and technicians apply several other complex equipment to the processes. Biotechnological processes are slower than those used for the production of small molecules drugs. For instance, it takes approximately one month to produce one batch of cenegermin.
Our people guarantee efficient manufacture
Our plant relies on state of art equipment and technologies, but efficient production is only made possible through the skills, successful management and teamwork of our people. We believe that every role in the company creates value for our business. We also promote an outlook of finding a solution to a challenge rather than dwelling on the problem. For instance, through the strong collaboration between different departments we can react and find solutions to changes in the market. We believe this is an important competitive advantage.
We also take a just-in-time approach in our plant, in which the ordering of raw materials is directly aligned with production schedules. This has proven remarkably successful.
Digitalization - Creating the plant of the future
At our L’Aquila site, we are always open to ways in which we can improve production performance. We are looking to digital technologies to offer such opportunities for improvement. Real-time availability of data that can be analyzed rather than merely collected will enable us to focus on improvement interventions in a more targeted and precise means.
Digital technologies also offer benefits beyond manufacturing processes, our research laboratories, maintenance, training program management and supply chain processes will all gain from an investment in digitalization. Our current production processes are already highly efficient, digital technologies will further optimize performance and boost efficiencies.
PRODUCTION TYPES
Small molecule-based drug products
(granular and coated granular products, drops, sprays, syrups, mouthwashes)Biotechnology derived active ingredients
(recombinant human Nerve Growth Factor)
PRODUCTION LINES
Sachets
Sticks
Liquids
Biotech API (upstream and downstream)
PACKAGES MANUFACTURED
Over 40 million packs per year
APPROVALS
AIFA (National Medicines Agency), Italy
EMA (European Medicines Agency), Europe
FDA (Food and Drug Administration), USA
NMPA (National Medical Products Administration), China
Health Canada
Ministry of Health of the Russian Federation
GLP (Good Laboratory Practices) Certificate of Compliance
CDMO
Contract Development and Manufacturing Organization
Facility specializing in developing and manufacturing biotech products.
Our internal quality and control system consider all phases of drug development and production. From the procurement of raw materials from our suppliers to the processing and packaging of the final product and then through to distribution. Before releasing products to the market, quality checks are conducted in three different labs:
Chemical Lab for chemical analysis
Microbiological Lab for analysis of the microbiological load
Packaging Materials Lab to verify the conformity of the packaging
Certifications
Certificates of Excellence
UNI EN ISO 9001:2015 certification
ISO 14001:2015 certification
UN ISO 45001:2018 certification