Avara Pharmaceutical Services’ Liscate sterile manufacturing facility completed several successful regulatory inspections in 2019. We continue to build on our high standards and extensive expertise to deliver high-quality products on time and in full.
A Flexible and Reliable CMO Experience
Avara Pharmaceutical Services is a contract manufacturing organization (CMO) whose goal is to provide an exceptional manufacturing and packaging experience by utilizing our institutional expertise, flexible and lean management structure, proven track record of regulatory success, and extensive global reach. In addition, we are focused on improving our operating costs by simplifying our supply chain and reducing client risk. We are continuously working to identify new ways to drive efficiencies, provide security of supply, enhance regulatory compliance, and build long-term confidence by delivering on our commitments.
Here at the Liscate, Italy, facility, we offer liquid and lyophilized fill-finish of sterile injectable products, high-containment capabilities, and a comprehensive range of manufacturing and packaging capabilities.
Liscate Overview
Here at the Liscate, Italy, facility, we offer liquid and lyophilized fill-finish of sterile injectable products, high-containment capabilities, and a comprehensive range of manufacturing and packaging capabilities, including aseptic filling into vials and ampoules; terminal sterilization; lyophilization; development labs and small-scale pilot equipment; multi-country labeling, finishing, and serialization; automated and manual packaging, including kitting; and high-volume automated packaging and labeling. Our facility — which was formerly owned by Pfizer — has benefitted in recent years from €30 million of investment into new technology and equipment, as well as a variety of facility improvements. We have a diverse staff of over 200 highly skilled team members and a proven, 50-year track record in sterile manufacturing, as well as 15 years in contract integrated manufacturing and packaging. We currently export to around 40 countries worldwide.
Successful Regulatory Inspections
In 2019, our facility closed out the year by completing several successful regulatory inspections. These included pre-approval inspections by AIFA, ANVISA, MFDS Korea and, most recently, the U.S. FDA for a new client’s product to be manufactured in the Small Volume Parenterals department. The U.S. FDA also conducted a routine GMP inspection for the Lyophilization department. We were delighted that these inspectors acknowledged the high standards and experience at Avara Liscate by recommending approval of the new product.
Leadership Expansion
With the completion of such an encouraging year in 2019, Avara Liscate has been looking forward to supporting existing and new clients in 2020. To further enhance our service capabilities, we appointed Vincenzo Riello as Manufacturing Director to the leadership team at the beginning of 2020. Riello has a wealth of experience in sterile manufacturing gained over many years in both large pharma organizations and CDMOs. Our previous Manufacturing Director, Marco Scanziani, has taken up the position of Customer Relationship Leader. He is now applying his 15 years of manufacturing and quality experience to leading the Project Management function, ensuring that Avara Liscate continuously improves on its ability to provide the most exceptional client experiences.
Meeting the Challenge
The appointments of these seasoned professionals have proven fortuitous, as we recently were faced with the great challenge of maintaining our business continuity through the global COVID-19 crisis. By following our Business Continuity Plan and the directives of local and world health authorities and efficiently utilizing all resources, we were able to mitigate the spread of the virus, safeguard the health of our employees, and ensure required production levels to support continuity of supplies and deliver on our commitment to our clients. Because our facility is responsible for producing essential sterile drugs to support the treatment of patients with the most severe cases of COVID-19 and others in intensive care, this was of the utmost importance. We are thankful that our facility was able to maintain its operational status throughout the duration of the pandemic and continue to deliver the life-saving medications to the patients we serve.