About corlife
Vision
Corlife has committed itself to improving the quality of life of people undergoing heart or central blood vessel surgery. We develop innovative and safe products for this purpose. We are aware of our responsibility towards patients, tissue donors, cooperation partners, physicians and employees. Safety, quality and empathy determine our actions.
History
Discover more about the history of corlife in this slideshow.
1996: The Nineties
Physico-chemically conditioned bone and tendon transplants have been used successfully in patients for quite some time. The transplants are largely cell-free and sterile and are therefore safe and well tolerated. Axel Haverich, Head of Cardiothoracic, Thoracic, Transplantation & Vascular Surgery, founded the Leibniz Research Laboratories for Biotechnology and Artificial Organs LEBAO in Hannover in 1996. There, these technologies are applied to blood vessels and heart valves for decellularization. After innumerable in-vitro experiments, a few methods that appear to be safe can be verified in animal models. The researchers are in competition with working groups in Germany, Brazil and the USA.
2006: Foundation
Corlife is founded for the "development, production and distribution of pharmaceutical products and medical devices". From the beginning, the company is financed and managed exclusively by the founders (Axel Haverich, Clemens Meyer-Kobbe, Michael Harder).
2008
Photo: © Ansgar Pudenz/German Future Prize
Axel Haverich and Michael Harder, as well as the Moldavian-born physician Serghei Cebotari, are nominated for the German Future Prize. The nomination for this recognized innovation prize meets with resistance from a competitor and the press. In essence, the nominees are accused of not pursuing an independent and innovative strategy and of disregarding essential ethical standards. The nomination is revoked. The ethical accusations prove to be groundless. The patent opposition proceedings are concluded to the advantage of corlife.
2011: New clean rooms
Photo: Karin Kaiser/MHH
Corlife and the Hannover Medical School (MHH) started up new cleanrooms for the production of innovative implants on 16.05.2011. The project was funded by the State of Lower Saxony and the European Commission. Prof. Dr. Johanna Wanka, Lower Saxony's Minister for Science and Culture, inaugurated the rooms together with Prof. Dr. Axel Haverich, Director of the Clinic for Cardiac, Thoracic, Transplant and Vascular Surgery, Prof. Dr. Christopher Baum, Dean of Research at the MHH, Dr. Michael Harder, Managing Director of corlife and Dr. Andreas Tecklenburg, Vice President of the MHH (from left to right).
2012: European clinical study on the use of regenerative heart valves (ESPOIR)
Photo: K. Fuchs, Medizinische Hochschule Hannover
The aim of ESPOIR is to assess the safety and tolerability of cell-free pulmonary valves in clinical application. Leading collection facilities and clinics in Brussels, Chisinau, Hannover, Leiden, Leuven, London, Padua, Vienna, Zurich and corlife are involved. The consortium is accompanied by an independent Ethics and Governance Council. ESPOIR is awarded the ENCePP Study Quality Seal for maintaining high standards based on the principles of scientific independence, transparency, and robust methodologies (PAS28980). ESPOIR was successfully completed in 2016. The results are available to the public. ESPOIR was supported by the "Seventh Framework Programme of the European Community for Research, Technological Development and Demonstration Activities" with the grant number 278453.
2013: Approval
On 29.08.2013, after 17 years of tireless research and development, the Paul-Ehrlich-Institut approves the "Cell-free human pulmonary valve, Espoir PV" as a medicinal product.
2015: ARISE
The Paul-Ehrlich-Institut approves the "Cell-free human aortic valve, Arise AV" as a medicinal product. In the same year the European observational study ARISE starts in Austria, Belgium, Germany, Italy, Netherlands, Spain, Switzerland and the United Kingdom, funded by the HORIZON 2020 Program of the European Union (#643597). The study results children and adults will be published in 2020.
2019: 500
Photo: Anna Junge
Corlife delivers the 500th cell-free heart valve to the university hospital in Erlangen.
Team
Discover more about the corlife Team in this slideshow.
Dr. Michael Harder, Managing Partner
My mission is to act in a socially, ethically and entrepreneurially responsible manner and to offer innovative and helpful products and services for the care of patients.
I studied biology (biotechnology) many years ago, have been working in research and industry for 30 years. I have manage corlife since its foundation in 2006.
The development, production and distribution of innovative, cell-free allograft products presents us with new ethical, technical and regulatory challenges every day. My task is to set the necessary course in time and to mobilize sufficient resources to meet this challenge.
Dr. Bettina Giere, Head of Quality Control & Procurement
A holistic view of the processes is important to me in order to consistently ensure a high quality standard.
After studying veterinary medicine and several years of research, I joined the company in 2006 and have been involved in many development processes in the field of tissue processing.
My responsibilities include procurement and quality control. The earlier the quality control starts in the processes, the more effective it is. This area of responsibility extends from the selection of materials to process and product monitoring. The microbiological monitoring of the processes and allografts and checking for freedom of cells are particularly intensive.
Dr. Bianca Lindner, Quality Management Representative, Head of the Manufacturing Environment
For me, quality does not begin with the product. Rather, it is lived in all processes in the company and is constantly being developed further. I work on this development every day.
As a chemist, I worked for several years in biotechnological research. The subsequent qualification as an auditor enabled me to combine laboratory practice with regulatory theory.
Since 2015 I have been in charge of quality management at corlife and in this function I am responsible for monitoring the manufacturing environment including the clean room.
Dr. Ralf Haller, Research & Development (Responsible person §§ 20b, 20c AMG)
The increase of effectiveness and the development of innovative products are especially close to my heart.
After studying "Molecular Life-Science" at the University of Lübeck, I received my doctorate in the field of cell biology at the Medical School of Hannover.
I have been working for corlife since 2018 and my main tasks include the optimization of workflows in the manufacturing process and the development of innovative cell-free allografts, e.g. from tissue donations that are not primarily suitable for transplantation.
In addition, I am responsible for the acceptance of tissue donations and their processing and release for transplantation.
Dr. Carmen Puschmann, Regulatory Affairs
On the long road to a medical device, patient safety is always my top priority.
I am a biologist and have been developing medical devices for corlife since 2006.
I determine all relevant normative and regulatory requirements for a medical device, consider possible risks in detail and design testing and validation procedures. This activity involves many internal and external audits, so that theory and practice do not diverge. All processes for development, production and testing, up to CE marking, are part of the quality management system of corlife.
Nicolin Heister, Head of Regulatory Affairs
My goal is to guarantee drug safety and ensure the greatest possible transparency vis-à-vis authorities, users and patients.
I have been working for corlife as a biologist since 2009. I am the contact person for all questions regarding approvals and vigilance vis-à-vis authorities and users. In addition, I organize and support information events for patient organizations.
My responsibilities include the planning, execution and monitoring of studies in which our cell-free allografts are followed up. The findings from studies are the basis for measures to improve safety.
Dr. Marco Lux, Head of Pharmaceutical Production (Responsible person §§ 20b, 20c AMG)
Tissue donations are a precious and rare treasure. Every tissue donation that we receive in trust deserves great attention and care. My goal is to turn these donations into very well tolerated implants and to continuously improve their quality.
My biological education began with the study of "Molecular Life Science" at the University of Lübeck. During this phase I developed a strong interest in tissue engineering, which I deepened during my doctorate at the Medical University of Hannover.
Since 2015 I have been leading the production of cell-free human tissues at corlife. This activity comprises the assessment of tissue donations, their processing and release, as well as their dispatch to the clinics.
Culture
Work of heart.
We are from different cultural backgrounds, cover a wide age range and have learned different professions. We are united by the will and ability to develop and produce good, safe and sustainable products for patients.
We are looking forward to new team players who enrich us with their knowledge and commitment and who are looking forward to helping us shape the future.
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