Prof Hanns-Christian Mahler
Chief Enablement Officer and Board Member

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About

Professor Hanns-Christian Mahler, PhD, is Chief Enablement Officer and Board Member of ten23 health. He previously built and led the Drug Product Services Business Unit at Lonza AG (2015 to 2021), led different organisations involved in sterile product development and sterile manufacturing at F Hoffmann-La Roche (2005 to 2015) and worked as Principal Scientist and Chemistry, Manufacturing and Controls Leader at Merck KGaA (2000 to 2005).

Prof Mahler is additionally Lecturer and Adjunct Professor at the University of Basel and University of Frankfurt/Main, Editor for various scientific journals, and serves as an Expert at the European Pharmacoepeial commission. He studied Pharmacy and holds a PhD in Pharmacology & Toxicology from the University of Mainz (Germany) and obtained his venia legendi and title as extraordinary Professor from the University of Frankfurt/Main. (Germany).

Contributions

DEVICE SELECTION: INJECTION VOLUMES FOR SUBCUTANEOUS ADMINISTRATION

Nicolas Brandes, Andrea Allmendinger and Hanns-Christian Mahler explore the critical considerations for subcutaneous injection volume, beginning with the historical and scientific perspectives on injection volume before delving into the challenges of determining volume ranges and their associated fill volumes.

More contributions

TECHNICAL CHALLENGES DURING THE DEVELOPMENT OF ON-BODY INJECTORS

Andrea Allmendinger, Michael Adler, Carole Delauney and Hanns-Christian Mahler provide an overview of large-volume wearable injection devices for the subcutaneous delivery of biologics and discuss the technical challenges associated with the development and manufacturing of these drug/device combination products.

TRANSITIONING FROM VIAL TO SUBCUTANEOUS INJECTION DEVICES FOR BIOLOGICAL DRUG PRODUCTS

Michael Adler, Venkata Appa Reddy Goli, Andrea Allmendinger and Hanns-Christian Mahler, discuss the various factors that need to be considered when transferring to a delivery device for subcutaneous injection, such as a prefilled syringe or autoinjector, during clinical trials or post-launch, especially when transferring from a vial format for intravenous infusion.

ADDRESSING INTRAVITREAL PRODUCT MANUFACTURING AND DEVELOPMENT CHALLENGES

Andrea Allmendinger, Hanns-Christian Mahler and Philipp Behrendt discuss the challenges of filling very small volumes into syringes for intravitreal injections, and how ten23’s innovative filling technology can help combat the critical issue of air bubble formation.

INDUSTRIALISATION

INTEGRATED DRUG PRODUCT DEVELOPMENT AND MANUFACTURING

Andrea Allmendinger; Michael Adler and Hanns-Christian Mahler highlight the importance of integrated drug product development, considering aspects such as formulation, device, container closure system, manufacturing processes and usability, as well as considering the quality target product profile and clinical phase-appropriate technical development strategy.

INTRAVITREAL INJECTIONS – MORE THAN MEETS THE EYE: A TECHNICAL VIEW OF PRODUCT USE

Andrea Allmendinger and Hanns-Christian Mahler highlight the technical challenges of intravitreal administration and considerations from the ophthalmologist’s and patient’s perspectives.

PREFILLED SYRINGES

ANTICIPATING & MITIGATING CHALLENGES IN THE COMMERCIALISATION OF PREFILLED SYRINGES & INJECTION DEVICES – A TECHNICAL DRUG PRODUCT PERSPECTIVE

Andrea Allmendinger and Hanns-Christian Mahler both at ten23 health, provide an insight into the challenges of integrated development of drug product and device design and fill-finish manufacturing operations.

HOW TEN23 HEALTH IS MEETING DEVELOPMENTAL CHALLENGES FOR INTRAVITREAL PRODUCTS

Andrea Allmendinger and Hanns-Christian Mahler highlight new regulatory and quality requirements for intravitreal applications and discuss technical challenges during drug product technical development and manufacturing.

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