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Sitting down with Susanne Resatz

Sitting down with Susanne Resatz

Hello Susanne. Thank you for taking the time to answer some questions about yourself and the Vetter facility in Chicago. First, congratulations on your new role as President. Let’s begin by asking you how you wound up in Chicago and a bit about the facility.

Thank you very much. It is indeed exciting to be named President for the Chicago site, and to be heading up a team of professionals dedicated to bringing about a greater level of support to our customer base.

As for my being in Chicago, I am proud to say that I was part of the initial team that first arrived in Chicago in 2010 to help establish this facility, the first outside of our home country of Germany. Before I assumed my new role as President October of last year, I was responsible for all tasks relating to Process Development and Manufacturing for incoming customer projects. Since those early days, both our facility and our staff have grown significantly. Today, the site employs round about 50 professionals.
 

Can you now give us an overview of what your Chicago operations incorporate?

Yes, of course. Our Chicago site offers more than 30,000 square feet of advanced aseptic development and filling technologies. We support early-stage injectables from preclinical through Phase II, which is a very critical phase in the drug development process. Our customers in this stage of development often deal with new highly complex molecules that are often not yet fully understood when they are being processed.

For them we can perform flexible cGMP filling for all common drug delivery systems including vials, syringes, and cartridges. We are operating in total three clinical filling cleanrooms, supplemented by on-site microbiology and chemical analysis labs, material preparation, compounding and visual inspection.
 

No doubt, a significant amount of work was accomplished at the facility from your start in 2010 until today. How has the site matured from those early days?

That is an interesting question. When the site was first operational in 2011, we had two cleanrooms which provided fully automated vial filling as well as really small-scale semi-automated filling. Since that time, we have expanded the facility twice. In 2012 we expanded analytical and microbial testing and, most recently completed a further expansion step by adding a third cleanroom. So we are now able to fill single-chamber syringes with a maximum filling speed of 3,600 units per hour, and batch sizes as large as 25,000 units. At present, our available syringe format is 1ml long, covering fill volumes ranging from 0.1-1.1ml per unit.

We undertook this expansion because we see syringes as being very user friendly and believe they will become ever more important in the future of drug-delivery for many indications. Today, we are especially pleased to be able to offer our customers an early platform access to drug development through filling vials, cartridges and syringes. So we can enable them to utilize the final packaging material already in the early development phases, depending upon their individual product characteristics and planned launch strategy.
 

This is impressive and supportive evidence that Vetter’s strategy in creating the site was the right one. Would you agree?

I absolutely agree. To date, we are very satisfied with the growth of this facility. Since becoming fully operational just four short years ago, this site has performed exceptionally well and has already released several customer batches for clinical trials. Our local revenue is being generated by a mix of customers that serve both the US and ex-U.S. markets. This includes companies located as far away as South Korea, Israel, the Netherlands and Austria, with treatments under development for cancer, muscular dystrophy, dwarfism and other conditions.

Further, the Chicago site plays an integral role for us as a company overall since it allows our customers a seamless product transfer to our large-scale manufacturing facilities. We are proud to report that the first customer products in development have already been transferred from Chicago to our European facilities for Phase III and commercial manufacturing – a great success and great milestone for us.
 

Thanks much Susanne for taking the time to sit down with us for this interview, and for keeping us in the loop about Vetter’s operations in Chicago.