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Global Business Reports US Biopharmaceuticals 2019

March 13, 2019
Article > Interview with Dr. Michael Quirmbach in Global Business Report's US Biopharmaceutical Report 2019.

Article > Interview with Dr. Michael Quirmbach, Chief Business Officer, CPI

Global Business Reports – US Biopharmaceuticals, 4/2019

Could you update us on the recent developments at CordenPharma?

As of November 2018, we have completed our US$20 million investment in CordenPharma Caponago (Italy). The construction resulted in a 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 and tub technology. One of the new lines is already operational, with a successful FDA pre-approval inspection for two products, which 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 (Germany), which had begun at the end of 2017 with a target completion date during Q1 2019. The facility is dedicated to producing veterinary drug products for 500-kg scale batch sizes to supply a complex innovative product. 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.

Many contract service providers are looking more towards biotech for new opportunities. Is CordenPharma also following this trend?

We have received an increasing amount of interest from smaller companies, mainly biotechs and mid-sized pharma companies. There are hundreds of biotechs in the major hubs of San Diego, San Francisco and Boston that will look to outsource parts of their operations following initial trials. Biotechs now represent nearly 50% of our overall portfolio, with oncology being the strongest representation. We have extensive manufacturing capacities combined with strong capabilities in highly potent and oncology manufacturing, both for drug substance and drug product, within four cGMP facilities – two in Boulder, Colorado for Drug Substance and two in Europe (Germany and Italy) focusing on Drug Product manufacturing, for oral solid dosage and injectable sterile fill and finish respectively.

What is your value proposition for small biotech companies and your strategy to gain more market share in this space?

The value we bring is our proven experience in manufacturing and regulatory knowledge, ranging from initial support for clinical phases all the way to commercialization of their products. In addition, our offering spans the cGMP spectrum, from the production of their active pharmaceutical ingredients (APIs) to their drug products, packaging and shipping across a broad range of global commercial markets. We offer a fully-integrated opportunity organized under five distinctive technology platforms and nine manufacturing facilities.

What are some of the challenges that a contract development and manufacturing organization (CDMO) faces in terms of maintaining a facility to the highest standards?

A key challenge for a CDMO, especially for those working with highly potent and oncology compounds, is having adequate containment infrastructure, systems and processes to make sure there is no cross contamination and adequate protection between products and operators. Overall, this is a very complex subject for any pharmaceutical company or CDMO. While maintaining all these pre-requisites in place is costly, it is a small price to pay to alleviate greater unforeseen costs down the road. Microgram quantities of oncology compounds are enough to cause contamination issues and potentially severe adverse reactions to patients.

Are you seeing a continued trend of outsourcing from biotechs and large pharma?

We are continuing to see many companies outsourcing their manufacturing assets and offloading their facilities. A lot of the large pharmas are divesting facilities to focus more on their core expertise in marketing and initial R&D. This is a trend we are also seeing across Asia, including in China. A lot of Chinese companies have reached out to us in an effort to release their products in the United States.

What are the key milestones for CordenPharma moving forward?

CordenPharma’s key milestones are continued growth of our technology platforms to re-inforce our position as industry leader in these segments. We are currently a €400 million company, but seek to be a much larger player in the industry. We still have significant capacity available to accommodate further growth, especially in our two US facilities where we are currently involved with a few late Phase III assets. If these go to commercialization, we feel confident our sales could double in the United States in the coming years.

Could you provide a final message to our international readership?

The global pharmaceutical industry is a very exciting environment to currently be a part of and provides an incredibly wide range of opportunities for any individual interest in this area. Also, while the pharma industry goes through significant changes and is confronted by cost pressure from governmental institution, the demand for the research of new medications tackling unmet medical needs (both in developed and emerging countries) remains high. CDMOs play an important part in today’s pharma value chain – from outsourcing of single services to full supply chains – with the latter being the future of the industry.

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