Investments & New EU Centres of Excellence

March 13, 2019
Article > Chemistry Today Takes Five Minutes with CBO Dr. Michael Quirmbach before DCAT 2019.

Article > Chemistry Today Spends Five Minutes with CBO Dr. Michael Quirmbach

Chemistry Today – Jan / Feb 2019 vol. 37


ANY UPDATES ON SOME OF YOUR MOST RECENT KEY STRATEGIC INVESTMENT / EXPANSION PROJECTS?

At the end of 2018 we successfully completed our US$20 million flagship investment in CordenPharma Caponago (IT). The construction resulted in our new commercial aseptic fill and finish injectable plant, consisting of two highly flexible filling lines enabling the manufacture of a broad range of vials, Pre-Filled Syringes (PFS) and cartridges using state-of-the-art nest & tub technology. Both lines have been approved by AIFA and one of the new lines is already operational, with a successful PAI FDA inspection for two products. Overall, the two new lines will increase the manufacturing capacity to 20 million units per year and add expanded lyophilization capacity.

Furthermore, we are in the process of completing the final instalment of a new manufacturing line in CordenPharma Plankstadt (DE), which had begun at the end of 2017 with a target completion date during Q1 of 2019. The facility is dedicated to producing Veterinary Drug Products for 500 kg-scale batch sizes to supply a complex innovative product for application in the veterinary health market. The expansion of the production capabilities at CordenPharma Plankstadt are the result of a new, long-term custom manufacturing agreement for an animal health application, which the company recently signed

CAN YOU UPDATE US ON ANY OTHER RECENT DEVELOPMENTS TAKING PLACE AT CORDENPHARMA?

During 2018 we implemented two major changes to service offerings at our European sites – one in the area of Peptide manufacturing and the other one as it relates to our Small Molecule development activities. Our CordenPharma Brussels (BE) site was historically and predominately active in the development and manufacturing of peptides using LPPS (Liquid Phase Peptide Synthesis). Although this remains a core technology of the site, the growing trend towards the application of SPPS (Solid Phase Peptide Synthesis) resulted in a relocation of SPPS equipment from CordenPharma Switzerland to Brussels, in order to consolidate peptide activities in Europe to create an EU Centre of Excellence. This allows for peptide manufacturing via both LPPS & SPPS technology at one location, which is supported by our state-of-the-art R&D Centre in Frankfurt (DE).

Secondly, in order to accommodate the increasing demand for early-stage small molecule development and manufacturing resources, CordenPharma established a dedicated small molecule R&D center at CordenPharma Switzerland. The site has an outstanding track record in supporting a range of customers from small biotech to large pharma with the supply of clinical trial batches destined for phase I – II. CordenPharma Switzerland is well-positioned within the CordenPharma network of facilities to collaborate with CordenPharma Chenôve (FR) and Bergamo (IT), which are available to accommodate larger quantities of small molecules required for late-stage or commercial supply.

CORDENPHARMA WAS FOUNDED THROUGH THE ACQUISITION OF BIG PHARMA MANUFACTURING ASSETS IN THE LAST 12 YEARS – HOW HAS THE BUSINESS DEVELOPED OVER THE YEARS / CUSTOMER BASE?

CordenPharma is now an established player in the CDMO arena known as a reliable and trustworthy partner with distinctive service offerings organized under 5 technology platforms.

This achievement was the result of hard work over the last 5 years, when we took the time to listen to our customers, and answer their needs by deriving and executing sound strategic decisions. Today, we are pleased to have successfully replaced the legacy business inherited through the acquisition of the manufacturing assets from Big Pharma with a broad range of new capabilities. In this context, it is noteworthy that we were able to demonstrate strong top line growth through the development of new accounts, with customers spanning a wide range from biotechs to mid-size and large pharma. In this process we expanded services to not only cover initial clinical phase I to commercial supply of APIs & Drug Products, but also formed a fully-integrated supply solution which has been in strong demand and well-received by the market. So overall, while we initially started with a small customer base comprised mostly of legacy customers, we are now serving a broad and comprehensive customer base in key markets such as North America, Europe, Japan and India, which transformed our initial ~80% dependency on legacy business into a healthy outlook of 35%.

WHAT IS THE FOCUS AT CORDENPHARMA TODAY AND IN THE FUTURE – ANY CHANGES IN THE SERVICE OFFERING?

We will continue to strengthen service offerings across our platform technologies – with a particular focus on the four core platforms of Injectables, Small Molecules, Highly Potent & Oncology, and Peptides, Lipids & Carbohydrates – through strategic investments for either capacity expansion or additional line extension to meet increasing customer demands or close existing gaps in our offerings, respectively.

On the other hand, we are currently taking a more defensive approach to our Antibiotics platform by initiating measures to close some product lines at our Latina (IT) site, namely in the oral cephalosporin & penicillin and sterile penicillin drug product manufacturing areas. Major drivers for this decision are fierce competition, difficult market conditions and price erosion of a mature market with limited opportunities and a sparse outlook for the coming years.

Nevertheless, CordenPharma’s key milestones are continued growth of our technology platforms to reinforce our position as industry leader in these segments. We are currently a €400 million company steadily moving in the direction of being a much larger player in the industry, with significant capacity available to accommodate future growth.

CORDENPHARMA IS OWNED BY ICIG, WHICH ALSO OWNS WEYLCHEM AND OTHER PLATFORMS – HOW DO YOU COLLABORATE AND WHAT ARE THE BENEFITS FOR THE CUSTOMERS?

Weylchem is the fine chemicals custom manufacturing (nGMP) platform of ICIG consisting of 10 manufacturing plants based within Europe and the US. Through their operations, we are able to offer our customers valuable back integration towards the manufacturing of either raw materials or registered starting materials, particularly when they require a Western supplier as part of their sourcing strategy. To this end, Weylchem utilizes a very strong and broad chemistry technology base (e.g. low temperature, high pressure, ability to handle a wide range of noxious reagents) allowing us to effectively handle any chemistry at any scale within Europe and the US. Over the last few years, we have successfully executed multiple joint projects with Weylchem for customers in the US and Europe, providing the collaborative benefit of a truly back-integrated supplier with one point of contact from the CordenPharma Project Management and Sales teams.

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