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Related Concept Videos

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

139
Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
139

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Related Experiment Video

Updated: Jan 10, 2026

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Navigating PUPSIT implementation challenges for high-viscosity oligonucleotide drug products.

Yu Zoe Zhang1, Joseph Perchiacca1, Anya Batalina2

  • 1Drug Product Development - Steriles, Medicine Development and Supply, GSK, 1250 S. Collegeville Ave, Collegeville, PA 19426, United States.

Journal of Pharmaceutical Sciences
|November 20, 2025
PubMed
Summary

The revised EU EMA Annex 1 mandates Pre-Use Post-Sterilization Integrity Testing (PUPSIT) for sterile injectables. This case study addresses PUPSIT challenges for thermally sensitive oligonucleotide therapeutics, offering insights for industry compliance.

Keywords:
ASOEU EMA annex-1Filter sterilization methodGamma irradiationOligonucleotidePUPSITPolyethersulfone (PES) filterPolyvinylidene fluoride (PVDF) filterPre-use post-sterilization integrity testing

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Area of Science:

  • Pharmaceutical Manufacturing
  • Regulatory Compliance
  • Biotechnology

Background:

  • The EU EMA Annex 1 revision (August 2023) imposes stringent sterile manufacturing requirements.
  • Pre-Use Post-Sterilization Integrity Testing (PUPSIT) is a key challenge for the pharmaceutical industry.
  • Oligonucleotide therapeutics, vital for unmet medical needs, often require aseptic processing due to thermal sensitivity.

Purpose of the Study:

  • To highlight challenges in implementing PUPSIT for high-concentration, high-viscosity antisense oligonucleotide (ASO) drug products.
  • To inform on critical considerations for successful PUPSIT implementation in aseptic processing.
  • To provide insights into industry best practices and regulatory compliance strategies.

Main Methods:

  • Case study analysis of PUPSIT implementation for an antisense oligonucleotide (ASO) drug product.
  • Evaluation of formulation impact on PUPSIT.
  • Assessment of process design and risk management strategies for PUPSIT.

Main Results:

  • Identified significant challenges in applying PUPSIT to high-viscosity, high-concentration oligonucleotide formulations.
  • Highlighted the importance of formulation compatibility and process adaptability for PUPSIT success.
  • Demonstrated the need for robust risk assessment and strategic planning for regulatory compliance.

Conclusions:

  • Successful PUPSIT implementation for sensitive oligonucleotide therapeutics requires careful consideration of formulation and process design.
  • Addressing PUPSIT challenges is crucial for maintaining regulatory compliance with the revised EU EMA Annex 1.
  • This case study offers valuable insights for the pharmaceutical industry navigating new sterile manufacturing standards.