GMP compliant CDMO business

The idea:

Develop a profitable CDMO business from zero.

The challenge:

Establish a business from scratch using state-of-the-art technology and gradually grow and maturate it to offer GLP and GMP compliant services to meet increasing customer demands.

The implementation:

In order to develop a fully GMP compliant CDMO business with a global customer base, Andreas started with the foundation of Celonic in Jülich in 2002. The site initially focused on cell-line and process development but soon expanded to also offer cell banking and full analytical service packages for in process control testing and later on GLP-GCP compliant analytics for preclincal and clinical analytics. Only one year later, another site was acquired in Marburg for which a license for GMP manufacturing was obtained, and the first GMP compliant cell line was developed. In 2005, the launch of a new safe technology platform for fast track cell-line development in suspension took place. In order to meet increasing the customer demand, a new site in Basel started its business in 2006, a real cornerstone in the maturation of the company. The facility served as innovative GMP manufacturing unit for the manufacturing of biologicals (bulk product) up to and including clinical phase II material (300 L stainless steel reactor). One year later,  the Basel facility was extended with a second manufacturing line up to 1000 L scale (single use bioreactor). At the same time, the CEMAX technology for site-specific integration of expression cassettes was launched and further boosted the cell line development activities of the company.
In 2012, 10 years after company foundation, Celonic underwent a trade sale to JRS.

Within 10 years, a profitable company was built from scratch, including 85 employees, a global client base of more than 50 customers in Europe, US, Asia and India and more than 100 successfully completed projects.

Biosimilar manufacturing plant

The idea:

In 2012, Dr. Andreas Herrmann received the mandate to establish a biosimilar company based in Iceland from scratch, with a fully GMP compliant commercial manufacturing plant.

The challenge: 

Establish a fully GMP compliant manufacturing plant from scratch within a short timeframe.

The implementation: 

Andreas was appointed as CEO of the company and, within 24 months, he successfully headed the construction of a production facility for API and final dosage forms for biosimilar antibodies (16.000 L API manufacturing capacity, 3 Mio. vials / syringes filling lines; greenfield strategy, >14.000 sqm). During this time, he also drove the acquisition of a global acting, leading analytical service company to support biosimilar development, and established subsidiaries in Switzerland and Germany. To establish an initial pipeline of six biosimilar products, Andreas and his team secured financing of ca. 500 Mio. USD. Together with the !LEVA management team, four biosimilars where developed up to clinical phase I, and a partnership agreement with top three US-based pharma company was established for the co-development and sales of first biosimilar products.

Therapeutic antibody to treat COVID-19

The idea:

When the COVID-19 pandemic started, Prof. Stefan Dübel (University of Braunschweig), strived to develop a Fc-silenced therapeutic antibody against SARS-CoV-2 to treat hospitalized COVID-19 patients suffering from moderate and severe disease. For this reason, together with his colleague Prof. Michael Hust, as well as Dr. Thomas Schirrmann and Dr. André Frenzel (both YUMAB GmbH), he founded CORAT Therapeutics GmbH in May 2020.

The challenge:

Therapeutic antibodies targeting COVID-19 were thought to impose a safety risk on patients with severe disease and to accelerate disease progression. The challenge was to develop a silenced antibody that was safe to be used for the treatment of hospitalized COVID-19 patients. Due to the high need for effective treatments, the program was under significant time pressure. Many CMC, preclinical and clinical activities, which can usually be performed in a more staggered approach, had to be done in parallel, increasing the overall risk of failure. New virus variants spreading globally complicated not only the R&D and preclinical development, which had to constantly monitor binding of the drug candidates to new virus variants, but also the selection of countries for clinical studies. Finally, the continuation and successful completion of the clinical trial in Ukraine after the start of the war was a challenge in itself.

The implementation:

!LEVA Sciences was asked to support and to transform the product idea into a real company with a therapeutic product. Therefore, the !LEVA team was installed at the CEO, COO, and Project Director levels and asked to take responsibility for maturating the company, developing a product pipeline and driving the development of the lead candidate through to the clinic.

The project goal was achieved with unprecedented speed. Within only 11 months, the lead asset was developed from basic idea to First-Patient-In of clinical phase I. Within the first 21 months, 80 Mio. EUR were raised to support the product development, company growth, and portfolio diversification. The clinical phase I study was successfully completed and demonstrated a good safety profile of the compound.

As numerous tasks were carried out simultaneously, close monitoring and constant adaptation and refinement of the development processes was imperative. Reliable and strong partnerships were quickly established to complete as much work as possible in parallel. As a result, project teams grew rapidly and numerous deliverables were produced, requiring effective communication and document management. Regular meetings of decision makers, transparent communication at eye level with internal and external project members, as well as thorough and continuous risk monitoring, ultimately enabled quick decision-making by management to drive product development forward quickly and successfully.

Transition from medical device to ocular drug company

The idea:

In 2013, Hartmut took over the task to advise and closely work with the Dievini portfolio company Novaliq, which at that time was a 12 person R&D company exploring the potential of their platform technology as a drug delivery vehicle.

The challenge:

Leaving the beaten track, setting the company on a new path and pursuing it in a targeted and consistent manner.

The implementation:

Working closely with the founder & CEO, an ambitious, yet realistic corporate strategy was developed. A clear focus on just one promising therapeutic area and indication was chosen – topical eye drops for Dry Eye Disease - and a fully fletched pharmaceutical development company was established. Key personnel such as CFO, CTO, CMO and clinical development lead was hired, and a 60-person organization was built. A high class scientific advisory board and KOL network was established. A low-risk strategy towards fast a revenue stream was chosen, and first product was introduced to German Pharmacy as a medical device in 2016 as a most innovative lubricating eye drop, EVOtears.
Pharmaceutical development was continued in parallel, QA/QC management team, formulation and analytical CMC team, pre-clinical and clinical development team, IP department and a small but powerful admin team were established. The founding CEO stepped back in favor of an experienced CEO from the eye pharma industry to get the company ready for the eye pharma drug market.
All this transformation was accomplished within the shortest possible time frame – the pharmaceutical development took only seven years – and in May 2023 Novaliq got two drugs approved by the FDA with blockbuster potential, Miebo and Vevey.
As always – success is result of hard and good teamwork – and as driving forces, Hartmut and the Novaliq managers gained wide experience across the whole pharmaceutical value chain. As a result, Hartmut is co-inventor of Novaliq’s drug patents.