Edition 2 / December 2018
Welcome to the second edition of Corden Connect! As in our first edition, we will continue to provide you with thought leadership, industry perspectives, and regular updates on recent developments in relation to our five Technology Platforms, which were created to provide you with the full benefit and added value of an Integrated Supply spanning early-phase to commercial manufacturing of APIs, Drug Products, and Pharma Packaging & Logistics. Delivering added value to our customers as a CDMO is our focus and remains our ambition as we drive from top down to shop floor and back – a cohesive network from Corporate Management to Plant Operators working together to support your supply of critical medications to patients!
In this context, the second half of 2018 continued to be exciting for CordenPharma. One of the highlights was the successful recertification of the highly potent compound program by SafeBridge® Consultants in our CordenPharma Colorado facility. The recertification, which has been maintained since first awarded in 2013, included a thorough onsite assessment of physical plant features, programs, exposure controls, procedures and practices applied towards the manufacturing of highly potent Active Pharmaceutical Ingredients (APIs), consisting of a review of over 60 elements.
Another 2018 highlight is the successful inauguration event of our new aseptic fill & finish line for injectable drug product manufacturing at CordenPharma Caponago on November 5th. This well-attended one day celebration consisted of keynote lectures providing our customers fresh industry perspectives & insights into this brand new state-of-the-art facility, which will increase the injectable manufacturing capacity up to 20 million vials per year and add expanded lyophilization capacity.
As compliance remains the central topic for our industry, customers and ultimately patients, I want to emphasize our two most recent successful FDA audits which took place at CordenPharma Bergamo (IT) and CordenPharma Switzerland, the former one resulting in a Voluntary Action Indicated (VAI) status and the latter one with no 483 observations reported. This adds another mark to our longstanding record of accomplishment reflecting the strong commitment and highest degree of professionalism from our Global Compliance Team and employees in regards to compliance.
I would like to mention the most recent hires to CordenPharma International which strengthen our R&D, Tech Transfer and Global Project Management teams. Both Adriano Indolese (Global Head, R&D & Technology Transfer) and Andrea Brecht (Global Head, Project Management) bring broad, relevant industry experience garnered in their previous positions and will report to our COO, Dr. Walter Kittl. We feel confident their contributions will ensure further harmonization and execution of our projects and products – Welcome to the CordenPharma team!
Finally, as we approach year-end, I would like to take this opportunity to thank you for your continued interest in CordenPharma – we appreciate our customers entrusting us with their valuable projects and products.
We wish you and your families a festive upcoming holiday season and looking forward to re-Connecting in 2019!
Dr. Michael Quirmbach
Chief Business Officer,
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