Summary
Overview
Work History
Education
Skills
Certification
References
Timeline
Generic

Astrid Walther Christiansen

Copenhagen

Summary

Formulation Scientist with extensive experience in the development of protein and nanoparticle-based liquid parenteral formulations. Specializing in ensuring optimal efficacy, stability, and safety of biologic drug products, I have a strong background in preclinical and early clinical drug product development. My expertise includes designing, analyzing, and reporting accelerated and long-term stability studies to support the progression of drug products through clinical trials. Driven by a passion for continuous learning, I am always seeking opportunities to expand my knowledge and enhance my skills.

Overview

3
3
years of professional experience
1
1
Certification

Work History

Formulation Scientist

Statens Serum Institut
Copenhagen
08.2022 - Current
  • Formulation Development: Specialize in developing protein and nanoparticle-based liquid parenteral formulations, ensuring optimal efficacy, stability, and safety for biologic drug products. Focused on preclinical and early clinical development, ensuring smooth progression from early-stage formulation to clinical trials.
  • Stability Studies: Design, analyze, and report on accelerated and long-term stability studies for drug products, ensuring that formulations meet ICH guidelines and maintain quality attributes under long-term storage conditions.
  • In-Use Compatibility Testing: Lead in-use compatibility testing to assess the performance and safety of formulations during clinical use.
  • Drug Product Work Package Owner: Lead drug product development from pre-formulation to clinical Phase I/II trials, ensuring that each phase meets necessary quality requirements.
  • Process & Analytical Development: Lead efforts to optimize manufacturing processes, ensuring product consistency and improving overall efficiency. Work closely with cross-functional teams to enhance the scalability of formulations.
  • Technology Transfer: Manage the transfer of critical formulation knowledge and technologies to external manufacturing partners (CDMOs), ensuring smooth transition and successful process scale-up.
  • Regulatory Documentation: Write Investigational Medicinal Product Dossiers (IMPDs) for clinical trial applications, collaborating with QA and RA teams to ensure compliance with regulatory standards.

Education

MSc Pharmacy -

University of Copenhagen
06-2022

Skills

  • Formulation of Parenteral Protein & Nanoparticle-Based Drug Products for Preclinical & Early Clinical Development
  • Stability Studies (Accelerated & Long-Term, ICH Guidelines)
  • In-Use Compatibility Testing
  • Process & Analytical Development
  • Technology Transfer & External Partner Collaboration (CDMOs)
  • Regulatory Documentation (IMPD)

Certification

  • GMP Basics, Key2Compliance (2023)

References

References available upon request.

Timeline

Formulation Scientist

Statens Serum Institut
08.2022 - Current

MSc Pharmacy -

University of Copenhagen

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Astrid Walther Christiansen