Recommended

Teva close to API business sale
Streamlined rAAV purification enables efficient upstream analytics – access now
First new IPF treatment in US for a decade
Webinar: Radiopharmaceuticals’ time-to-result challenge
AstraZeneca/Daiichi cancer drug boost
Takeda to move away from cell therapy
GSK appoints new CEO
news

Proposed non-animal derived reagent Chapter published

12
SHARES

USP’s proposed new Chapter < 86 >, which offers additional information on Bacterial Endotoxins Tests (BETs) using non-animal derived reagents, has been published as a General Announcement in advance of public consultation.

Proposed non-animal derived reagent Chapter published

Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents, proposed by the USP Microbiology Expert Committee, is now published as a General Announcement. This is in advance of the official open comment period, according to USP. Comments are welcome from 1 November 2023 to 31 January 2024.

 

ACCESS your FREE COPY

 


This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.

Access the full report now to discover the techniques, tools and innovations that are transforming pharmaceutical formulation, and learn how to position your organisation for long-term success.

What you’ll discover:

  • Key trends shaping the pharmaceutical formulation sector
  • Innovations leading progress in pharmaceutical formulation and how senior professionals can harness their benefits
  • Considerations and best practices when utilising QbD during formulation of oral solid dosage forms
  • And more!

Don’t miss your chance to access this exclusive report ! Access now – it’s free

The new standard was proposed by the committee earlier in 2023. This was based on the its evaluation of whether animal-free reagents could be used in addition to current methods for endotoxin testing utilising animal-derived reagents.

This new chapter includes methods for using several reagents, including recombinant Factor C (rFC) and recombinant cascade reagents (rCR). It offers information for manufacturers of new and established biopharmaceuticals on ways to incorporate them into their quality testing.

Information included in the proposed Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents

  • The user’s responsibility for reviewing a supplier’s primary validation package
  • Product suitability verification for use in testing products or materials (referencing <1226> Verification of Compendial Procedures)
  • The possibility that regulatory authorities may require supplemental data prior to acceptance.

According to USP, <86> Bacterial Endotoxins Test Using Recombinant Reagents will be published in Pharmacopeial Forum 49(6) [Nov.–Dec. 2023]. This revision proposal will include methods for recombinant Factor C (rFC) and recombinant cascade reagents (rCR).

In a recent publication in the Pharmacopeial Forum 45(5) [Sep.-Oct. 2019], the USP Microbiology Expert Committee proposed the inclusion of recombinant factors for endotoxin testing in chapter <85> Bacterial Endotoxins Test.

The USP’s committee went onto cancel this proposal, based on public comments. A separate informational chapter was developed to expand on the use, validation, and comparability of endotoxin tests based on recombinantly derived substances.

The proposed informational chapter <1085.1> Use of Recombinant Reagents in the Bacterial Endotoxins Test – Photometric and Fluorometric Methods Using Recombinantly Derived Reagents was published in the Pharmacopeial Forum 46(5) [Sep.-Oct. 2020]. It was cancelled by the USP Microbiology Expert Committee, again based on comments that were received.

Determining accurate estimation of true endotoxin concentration

Share via
Share via