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Protocol for the Solid-phase Synthesis of Oligomers of RNA Containing a 2'-O-thiophenylmethyl Modification and Characterization via Circular Dichroism
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Solution Oligonucleotide APIs: Regulatory Considerations.

Christian Wetter1, Chris Chorley2, Corrine Curtis3

  • 1Pharma Technical Regulatory, F. Hoffmann - La Roche AG, Grenzacherstrasse 124, 4070, Basel, Switzerland. christian.wetter.cw1@roche.com.

Therapeutic Innovation & Regulatory Science
|February 8, 2022
PubMed
Summary
This summary is machine-generated.

Manufacturing oligonucleotide active pharmaceutical ingredients (APIs) can benefit from a formulated API approach, where the API remains in solution with excipients. This strategy, while common for biologics, faces regulatory hurdles for oligonucleotides but offers potential advantages.

Keywords:
API mixFormulated APIOligonucleotidesRegulatorySolution API

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Area of Science:

  • Pharmaceutical Manufacturing
  • Drug Development
  • Oligonucleotide Therapeutics

Background:

  • Oligonucleotide active pharmaceutical ingredient (API) manufacture involves synthesis, purification, and lyophilization.
  • Post-lyophilization, APIs are re-dissolved with excipients for drug product formulation.
  • Current practices often isolate oligonucleotide APIs, but maintaining them in solution (formulated API approach) may offer benefits.

Purpose of the Study:

  • To explore the feasibility of a formulated API approach for oligonucleotide drugs.
  • To identify conditions for complying with existing regulatory guidelines for formulated APIs.
  • To propose modernization of guidelines for broader application of the formulated API approach.

Main Methods:

  • Review of existing regulatory guidelines for formulated APIs.
  • Discussion of technical aspects including risk management, GMP, facility design, and control strategies.
  • Analysis of regulatory submission requirements for formulated oligonucleotide APIs.

Main Results:

  • Conditions are outlined for compliant use of a formulated API approach for oligonucleotides.
  • Key considerations for risk management, GMP, facility design, control strategies, and regulatory submissions are discussed.
  • The study highlights regulatory challenges and proposes pathways for industry compliance.

Conclusions:

  • A formulated API approach for oligonucleotide drugs is achievable within existing guidelines under specific conditions.
  • Modernization of regulatory frameworks is suggested to facilitate wider adoption of this approach.
  • The manuscript encourages dialogue with regulatory bodies to advance oligonucleotide drug manufacturing practices.