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Development of Biopharmaceutical Drug-Device Products pp 813–829Cite as

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

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Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 35))

Abstract

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.

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Author information

Authors and Affiliations

  1. Pharmacokinetic Sciences, Novartis Institutes for BioMedical Research, Basel, Switzerland

    Gerard J. Bruin

  2. Device Development and Commercialization, Technical Research and Development, Novartis Pharma, Basel, Switzerland

    Marie Picci

  3. Pharmacokinetic Sciences, Novartis Institutes for Biomedical Research, Cambridge, MA, USA

    Kennneth Kulmatycki

Authors
  1. Gerard J. Bruin
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  2. Marie Picci
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  3. Kennneth Kulmatycki
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Corresponding author

Correspondence to Gerard J. Bruin .

Editor information

Editors and Affiliations

  1. Formulation Development New Biological Entities, AbbVie (United States), North Chicago, IL, USA

    Feroz Jameel

  2. Drug Product Development (Retired), AbbVie (United States), North Chicago, IL, USA

    John W. Skoug

  3. Combination Product Development, AbbVie, Inc., North Chicago, IL, USA

    Robert R. Nesbitt

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© 2020 American Association of Pharmaceutical Scientists

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Bruin, G.J., Picci, M., Kulmatycki, K. (2020). Chapter 34: A Case Study of Bridging from a Lyophilizate Formulation to an Autoinjector for Patient Self-Administration. In: Jameel, F., Skoug, J., Nesbitt, R. (eds) Development of Biopharmaceutical Drug-Device Products. AAPS Advances in the Pharmaceutical Sciences Series, vol 35. Springer, Cham. https://doi.org/10.1007/978-3-030-31415-6_34

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