Chapter 34: A Case Study of Bridging from a Lyophilizate Formulation to an Autoinjector for Patient Self-Administration

  • Gerard J. BruinEmail author
  • Marie Picci
  • Kennneth Kulmatycki
Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS, volume 35)


The case study in this chapter describes the development of the anti-IL-17A monoclonal antibody secukinumab from a lyophilizate formulation as used during the main Phase 3 program to a commercial autoinjector, including the associated development challenges for the first indication and development opportunities for nonclinical bridging studies in later indications. Moving from a lyophilizate formulation in vial to a prefilled syringe and autoinjector can be potentially accelerated by leveraging prior experience from an established drug or device constituent part in combination with a new device or drug. Technical development bridging studies, accompanied by a strong analytical comparability program, are the cornerstone of a successful bridging strategy and may include drug-device compatibility, design verification, simulated use human factors studies, and a thorough risk analysis. These studies might pave the road for an efficient and lean clinical program.


Prefilled syringe Autoinjector Lyophilizate Secukinumab PK comparability studies Human factor studies Subcutaneous administration 


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Copyright information

© American Association of Pharmaceutical Scientists 2020

Authors and Affiliations

  • Gerard J. Bruin
    • 1
    Email author
  • Marie Picci
    • 2
  • Kennneth Kulmatycki
    • 3
  1. 1.Pharmacokinetic Sciences, Novartis Institutes for BioMedical ResearchBaselSwitzerland
  2. 2.Device Development and Commercialization, Technical Research and DevelopmentNovartis PharmaBaselSwitzerland
  3. 3.Pharmacokinetic SciencesNovartis Institutes for Biomedical ResearchCambridgeUSA

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