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Dose Administration, Compatibility, and Clinical Usability of Biologics

This event is now available on demand.

Event Overview:

Biological drug products (DPs) need to maintain product quality during administration to ensure patient safety, considering diverse administration conditions across various clinical sites and hospitals. Key aspects involve handling procedures, DP compatibility with the administration container, assessing product quality and stability during hold time and administration, ensuring sterility, and verifying accurate dosage delivery. The focus on CSTDs with biologics has increased recently, possibly affecting dose delivery and drug product compatibility.

Key Learning Objectives:
  • IND section P.2.6
  • Phase-appropriate drug development
  • MABEL design and in-use studies
  • Biocompatibility
  • Protein aggregation
  • Physico-chemical stability of DPs during administration
  • CSTDs
  • IV bags
  • Microbial stability under in-use conditions
  • Handling DPs in pharmacies
  • The Pharmacy Manual for preparation and administration of DPs
Who Should Attend:
  • CEOs
  • CMCs/product team leaders
  • R&D managers
  • R&D scientists
  • Regulatory affairs specialists
  • Formulation development scientists and managers
  • Drug product scientists and managers
  • Analytical scientists and managers
  • Sterile production managers
  • CMCs Consultants


Featured Speakers

Professor Hanns-Christian Mahler, PhD
Professor Hanns-Christian Mahler, PhD
Chief Enablement Officer
ten23 health

Professor Hanns-Christian Mahler, PhD, is chief enablement officer and board member at ten23 health in Basel, Switzerland. He previously led the Drug Product Services business unit at Lonza, also in Basel, and worked in various leadership roles, such as head of pharmaceutical development and supplies at Roche and Merck. He has extensive expertise in formulation development, process development and validation, packaging/device development and integration, sterile manufacturing, and regulatory submissions, with numerous IND/IMPD and BLAs.

Professor Mahler studied pharmacy at the University of Mainz in Germany, where he earned his doctor of philosophy degree in toxicology from the Institute of Pharmaceutical and Biomedical Sciences, and pharmacist specialization degrees in toxicology and ecology, and pharmaceutical technology. He also has qualifications in business and marketing from AKAD University in Stuttgart, Germany. Professor Mahler obtained his venia legendi (authorization to hold lectures) from the University of Frankfurt in Germany and is adjunct faculty member and lecturer at the universities of Frankfurt and Basel. He also serves as editor for Pharmaceutical Research, Journal of Pharmaceutical Sciences, AAPS Open, and PDA Journal of Pharmaceutical Science and Technology.

Speaker's Email: hanns-christian.mahler@ten23.health
Speaker's LinkedIn: Hanns-Christian Mahler 


Adithya (Adi) Balasubramanian, MS
Adithya (Adi) Balasubramanian, MS
Business Development & Sales
ten23 health

Adithya (Adi) Balasubramanian, MS, is an experienced scientist and director of business development and sales at ten23 health in Basel, Switzerland. He has more than 15 years of experience in the biotech industry, including positions with Genentech, Regeneron, and Lonza.  

Balasubramanian’s expertise includes external collaborations, alliance management, and pharmaceutical development, with a particular focus on the formulation development of biologicals. Balasubramanian began his career as a research associate at Regeneron and Genentech, working on notable projects such as Eylea (aflibercept), Praluent (alirocumab), and Polivy (polatuzumab vedotin-piiq). He played a pivotal role in the early establishment of the technical operations team at ten23 health and the Drug Product Services unit of Lonza.

Above all, Balasubramanian is passionate about creating innovative solutions that enhance patient outcomes and experiences. He earned his master’s degree in molecular biology from the University of Southern California in Los Angeles and an undergraduate engineering degree in biotechnology from Anna University in Chennai, India.

Speaker's Email:adithya.balasubramanian@ten23.health
Speaker's LinkedIn: Adithya (Adi) Balasubramanian, MS


For any technical questions, Please reach out to Jordan Ramesh: Jramesh@mjhlifesciences.com