PRODUCTION
Genetic is authorised to manufacture:
- Proprietary medicinal products
- Medical devices
- Development dossiers
The manufacturing plant was finished in 2006 and is currently one of the most important and technologically advanced manufacturing, analysis and pharmaceutical plants on a national and international level. The plant has two production departments:
- Production area for pharmaceutical liquid forms;
- Production area for pharmaceutical solid oral forms.
Production quality, process safety and quality/environment/safety management are guaranteed by the following certifications:
The Liquids manufacturing department
Genetic Pharmaceutical Laboratory can develop and manufacture solutions and suspensions of non-corticosteroids, corticosteroids, low and high potency, and sterile prostaglandins in lots of 50 to 3,000 litres.
All the production lines and the aseptic filling process are microbiologically controlled by qualified experts using simulation tests (e.g. Mediafills).
Blow Fill Seal technology is used for the aseptic filling process of solutions and suspensions in single-use PE or PP containers.
Pharmaceutical forms
- Preservative free single-use sterile corticosteroids;
- Multidose sterile corticosteroids;
- Preservative free single-use sterile non-corticosteroid drugs;
- Aseptic eye drops and multidose drops with and without preservatives (APTAR and NEMERA systems);
- Nasal sprays and for otorhinolaryngology;
- Proprietary medicinal products pMDI;
- Oral liquids and syrups;
- Liquids for nebulisation.
The solid oral forms manufacturing department manufactures the following pharmaceutic forms:
- Capsules, tablets, film-coated tablets and effervescent tablets;
- Solid oral cancer drugs and immunosuppressants;
- High potency solid oral drugs and corticosteroids.
All production lines, both in the liquids department and the solid oral department, are fitted with hardware and software equipment for serialization, aggregation and application of the tamper evident seal (according to Directive 2011/62/EU of the European Parliament) to complete the secondary packaging of proprietary medicinal products.
pMDI manufacture
We have two departments for the manufacture of pMDI while respecting the environment.
Genetic manufactures solutions and suspensions with HFA propellants (hydrofluoroalkanes) while respecting the environment. Each batcher is directly connected to a complete product line for the final packaging, including a labelling machine, weight check and packaging machine and serialization and aggregation system. We have two departments for the manufacture of pMDI or non-pressurized sprays. The integration of all the activities, IT system and human resources allows us to maintain a high standard of quality.
Strict adherence to cGMP, cutting-edge technology and instrumentation of the highest level guarantee the very high level of Genetic products. Each production line has a dedicated air-handling unit with the packaging line having its own HVAC system.
The installation of a TOC analyser guarantees the automatic cleaning of each line. Each line is supplied with PW, WFI, clean steam, sterile nitrogen, compressed air and hot and cold water. The systematic microbiological monitoring of the clean rooms and personnel and the 100% check of CIP and SIP are standard.
Out-Licensing and Third Party production
Genetic offers third parties its expertise and experience in the development, supply of licences and concessions, registration, production and packaging of specialty pharmaceuticals and medical devices for human use in many pharmaceutical forms. The company’s expertise in process development, knowledge of laws and regulations, controlled supply chain and flexible management of technical requirements and production make Genetic a reliable, technologically advanced CDMO B2B partner.
Leading industrial partners that collaborate with Genetic S.p.A. through Licence and Production, Concession or Production agreements on behalf of third parties:
