Webinar Navigating Your Drug Journey to the Clinic

On-Demand Webinar | Navigating Your Drug Journey to the Clinic – A Guide from DNA to IND

Developing your drug and taking it to the clinic is a complex process, and getting it wrong can be costly. At Sartorius, we’ve supported more than 80 molecules to the clinic and 8 of those programs have achieved market approval — all through working closely with our extensive CDMO network. Based on our experience, we’ve identified several key factors to consider across the CMC process to ensure success including cell line development, scalable manufacturing, timelines, and many more. Join our expert panel as they expand on these key aspects, highlight risks and common pitfalls, and provide a guide to navigate your drug from DNA to IND.

What You Will Learn:

Learn essential CMC success factors from DNA to IND
Identify common pitfalls in therapeutic protein development, and learn how to avoid them
Gain expert insights on timelines and tech transfer in CLD

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Romina Gandenberger von Moisy

Manager of Sales Development Specialists CMTS

Romina Gandenberger von Moisy is managing the technical sales team at Sartorius, focusing on cell line development, testing, and banking services for customers in Europe, the Middle East, and Africa. She holds a master’s degree in biomedical sciences from Albstadt-Sigmaringen University and joined Sartorius in 2016 as a scientist for cell line development customer projects. Since then, she has held several positions related to cell line development and testing services. In addition to her role as team leader, she is also responsible for collaborations with CDMO partners in Europe, providing end-to-end solutions for clients.

Anne Bondgaard Tolstrup

Founder and owner of AbtBioConsult ApS

Anne B. Tolstrup, Ph.D., is an experienced biopharmaceutical industry professional with more than 25 years of involvement in the areas of biologics cell line and process development, genetics analyses, scale-up, process validation including process performance qualification (PPQ), clinical and commercial GMP manufacturing. She has extensive experience working with regulatory agencies, including FDA, EMA, and national agencies in Europe, both with respect to IND and BLA filings. Anne has supported more than 50 clients in various aspects of biologics drug development after she started her consultancy business, including strategic support, CDMO collaborations, regulatory filings, and technical due diligences for biotech and biopharma/pharma companies, service providers and investment banks.

Her expertise prior to founding AbtBioConsult is based on a Master and a PhD degree in Molecular and Cell Biology at the University of Aarhus, Denmark, followed by 15 years in Danish Biotech companies including Symphogen, and 7 years in the global biopharmaceutical companies Boehringer-Ingelheim and Biogen.

Anne has a very large international network in the Biopharma and Biotech industry, as well as with Contract Development and Manufacturers (CDMO’s).

Christoph Zehe, Ph.D.

Research Fellow

Christoph Zehe holds a Ph.D. in molecular and cell biology from the University of Heidelberg. He joined Cellca GmbH in 2007 (acquired by Sartorius in 2015), where he helped establish a leading platform technology for generating high-expressing cell lines. From 2011 to 2018, he held various R&D roles and currently serves as a Sartorius Research Fellow, focusing on technology development in synthetic biology, molecular biology, and cell biology.