Coriolis Pharma: The art of formulation development
Coriolis is one of the world’s leading independent service providers for formulation development of (bio)pharmaceutical agents (proteins, peptides, monoclonal antibodies, RNA/DNA carrier systems, virus-like particles, viruses and bacteria) and vaccines. An interdisciplinary expert team of highly qualified scientists with many years of experience in the field of biopharmaceuticals optimize and shorten the process of drug development through unique know-how, the use of innovative analytical methods, and the application of the latest scientific findings. The services provided by Coriolis include developing formulations for (pre-)clinical phases and commercialization, including freeze-drying (process development, optimization and scale up), conducting stability and in-use studies, and producing material for preclinical studies and protein analysis (particles, aggregates, structure) with state-of-the-art technologies. Susanne Simon interviewed the company founder Dr. Michael Wiggenhorn for IZB im Dialog.
IM DIALOG: How did Coriolis start up?
DR. Wiggenhorn : Coriolis is the first spin-off of the D epartment of Pharmacy at the Ludwig Maximilian University Munich (LMU). In 2008, we received an Exist Founder stipend from the Federal Ministry of Economics and Energy. The logistical support of the spin-off service of the LMU, the technical support of the professors of the department, and the opportunity to use the technical equipment of the department made a successful spin-off possible.
IM DIALOG: You moved to the IZB in 2009. Why did you choose this location?
DR. Wiggenhorn : The IZB is in close proximity to the institutes of the LMU and Max Planck Institutes for Biochemistry and Neurobiology as well as successful biotechnology companies. The close exchange with the scientists was crucial for us at that time and is still very important to us today. Moreover, without the services and flexibility that the IZB provides to start-ups, we would not have been able to continuously grow on this scale.
© Coriolis Pharma
“We offer formulation development for biopharmaceutical active ingredients at the highest level.“
Dr. Michael Wiggenhorn, CEO Coriolis Pharma
IM DIALOG: What is the advantage of having your company located on the campus?
Dr. Wiggenhorn: Firstly, the close cooperation on the Martinsried/Grosshadern campus enables us to meet the requirements of research scientists and then incorporate this knowledge directly into our developments. Aspiring entrepreneurs can have casual exchanges with established founders. Secondly, it simplifies the acquisition of employees. Many highly qualified scientists want to work in a dynamic company and live in an attractive location like Munich. We now employ over 80 people.
IM DIALOG: Can you explain what service Coriolis offers?
Dr. Wiggenhorn: We offer formulation development for biopharmaceutical active ingredients at the highest level. You have to think about it this way: a pharmaceutical/biotech company discovers a new active agent and wants to introduce this as a drug onto the market. Initial efficacy trials show great potential, so that studies in healthy subjects are the next step, the first clinical phase, before tolerability and efficacy are tested on patients in later clinical phases. The structure of new biotechnology products such as proteins, antibodies, vaccines or nucleic acid-based therapeutics usually necessitates injection as a solution. For this, the innovative active ingredients must be administered in a preparation where the active substances are stable and remain effective, are well tolerated, and meet regulatory requirements. We develop these preparations. From the manufacturing process to storage and application in humans, the highest quality and stability must be guaranteed, and we demonstrate this by using special analysis techniques. We can process new products based on viruses and bacteria in special safety S1/S2 areas.
IM DIALOG: Who are your customers?
Dr. Wiggenhorn: We work with both small and the 20 largest pharmaceutical and biotech companies worldwide. In addition, we support national research projects of the Martinsried/Grosshadern Campus as well as international collaborations. Our partners really appreciate that Coriolis brings in special project teams with a great deal of expertise, experience, equipment for production and characterization, and an organizational structure.
IM DIALOG: Has the market changed in the last 10 years?
Dr. Wiggenhorn: Yes, the market has changed. Pharmaceutical and biotech companies have to do much more. The issues and requirements of the regulatory authorities have grown and become more complex, while at the same time the timelines for drug development have become shorter. The cost pressure is noticeable. Technologically and analytically, we are leaders in the field of development and can thus offer the high quality and fast service our customers need.
“Yes, the market has changed. Pharmaceutical and biotech companies have to do much more.“
Dr. Michael Wiggenhorn, CEO Coriolis Pharma
IM DIALOG: Drug development is a complex process. What kind experts work at Coriolis?
Dr. Wiggenhorn: We work in three areas: formulation development for liquid drugs, formulation and process development for freeze-dried products, as well as analytical services including GMP (Good Manufacturing Practice) and legitimate release analysis. We combine the expertise of pharmacists, biochemists, chemists, biotechnologists and process engineers, and thus achieve the maximum degree of synergy in our expertise. The majority of our employees have a doctorate, with a focus on the areas of pharmacy and biochemistry. Understanding the behavior of the molecules and pharmaceutical-technological competence are the keys to success in formulation development. To build up this employee structure and competence in your own company is expensive and time-consuming. That is why companies are glad to use our service. In addition, we have our own in-house research department, especially for new methods and technologies, to give our customers a technological advantage in their projects. For us, the investment of time and money in this department is very important, because precisely this area and the findings are what clearly differentiate us from our competitors. In addition to opportunities to gain a doctorate, every year we also offer several students the chance to complete internships with us. In the coming year, the commercial department will also create apprenticeship positions.
IM DIALOG: What criteria do drugs generally have to meet before they can be administered to people?
Dr. Wiggenhorn: The key requirements for medications are safety, efficacy, and quality. One must always consider that the doctor and the patient place the highest trust in these points. Therefore, stability, storage stability, even with changing temperatures or purity, must be guaranteed. The efficacy must remain from the first day to the expiry date.
IM DIALOG: How did you finance the growth of Coriolis?
Dr. Wiggenhorn: We have grown naturally and never used funding from a venture capital company. This means we are independent. Next year we will celebrate our 10th anniversary, for which we will organize a scientific conference. Currently, we have completed our move within Martinsried to our own building in the Fraunhoferstrasse and look forward to continuing to be a campus member.