From product development to patients: Standards and measurement confidence for biological medicines

Experts across science, industry, and healthcare are invited to explore how standards and measurement science strengthen the development, quality, and reliability of biological medicines for patients.
  • EVENTS
  • From product development to patients: Standards and measurement confidence for biological medicines
When
11/02/2026 10.45 - 12.00
Location
Online
Sector
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Overview

Join the Innovate UK Sustainable Medicines Manufacturing Innovation Programme (SMMIP) and the Medicines and Healthcare products Regulatory Agency (MHRA) Science Campus for a practical session on how standards and reliable measurements facilitate the development and manufacturing of biological medicines and related diagnostics.

Through four short case studies — bacteriophage/antimicrobial resistance (AMR), the Monocyte Activation Test (MAT), activated factor XIa (FXIa) in immunoglobulins, and adeno‑associated virus (AAV) standardisation — the session will demonstrate how early engagement reduces rework, strengthens comparability and builds regulatory confidence.

The webinar will also highlight cross‑campus enabling platforms: next‑generation sequencing (NGS) and bioinformatics for reference standard characterisation; isotope dilution mass spectrometry (IDMS); quantitative nuclear magnetic resonance (qNMR) for quantification; and freeze‑dried reference standards. The programme will briefly link to sustainability through SMMIP activity, including the InSPIREmed programme. The session will close with a short forward look that identifies RNA and mRNA medicines as priority areas for pre‑competitive reference materials and measurement confidence frameworks.
 

Speakers will introduce

  • How the MHRA Science Campus supports standards and harmonised measurement across the development and manufacturing pathway, including where SI‑traceable measurement is not feasible.
  • Cross‑campus enablers that underpin comparability: NGS and bioinformatics for reference standard characterisation; IDMS (isotope dilution mass spectrometry); qNMR quantification; and freeze‑dried reference standards.
  • Real case studies demonstrating impact on development, manufacturing readiness and patient safety (bacteriophage/AMR; MAT for pyrogen testing; FXIa in immunoglobulins; and AAV standardisation).
 

What we aim to achieve

  • Clarify how to achieve robust, reproducible and harmonised measurement for complex biologics, including when SI units do not fully apply.
  • Show how the MHRA Science Campus and partners use reference materials, fit‑for‑purpose units, commutability and inter‑laboratory studies to support comparability and regulatory confidence.
  • Share short, practical case studies that illustrate how early engagement reduces rework and strengthens evidence packages across development and manufacturing.
  • Signpost simple routes to engage with the MHRA Science Campus and, where relevant, linked national programmes and partners. Briefly highlight RNA and mRNA medicines as priority areas for pre‑competitive reference materials and measurement confidence frameworks.
 

Who should attend?

SMEs, scale-ups and larger organisations developing biological medicines (including vaccines/mRNA, therapeutic proteins and biosimilars, advanced therapies) and diagnostics; as well as process development/manufacturing teams, QC/analytical scientists, academics and technology developers interested in standards, comparability and regulatory alignment.
 

Why attend?

• Understand when and how to engage on standards and measurement confidence to avoid rework, delays and extra cost.
• Learn practical approaches to harmonised measurement in biologics: reference materials, fit-for-purpose units (including IU/activity where relevant) and inter-lab studies.
• Hear four short case studies showing how measurement confidence improved decisions, comparability and patient safety, plus a brief forward look on priorities such as RNA medicines.
• See how enabling platforms (NGS/bioinformatics and IDMS) underpin standards development and performance comparisons.
• Understand how sustainability-focused manufacturing innovation links to measurement confidence (including InSPIREmed as an example).
Register for this event

Accessibility and Inclusion

We are committed to ensuring our events are accessible for all.

If you experience any barriers to registering, for any reason, please contact us by email: enquiries@iukbc.org.uk or phone: +44 03333 403250 and we will support your registration.

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