Newsletter | January 9, 2026

01.09.26 -- Reimagining HACCP And Other Process Flow Risk Analysis Methods Using Relational Risk Analysis

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Webinar: The mRNA Journey: From Design to LNP-Ready Molecules for Research

Discover an optimized end-to-end workflow for producing high-quality IVT mRNA for research applications. This Agilent webinar covers every step—from sequence design and PCR-based DNA template preparation to transcription, lipid nanoparticle formulation, and QC testing with Agilent TapeStation and Fragment Analyzer systems—enabling fast, reliable, small-scale mRNA production for non-clinical research such as vaccines, protein expression, and gene or cell therapy. Watch it here.

FOCUS ON QUALITY/ANALYTICAL METHODS

Reimagining HACCP And Other Process Flow Risk Analysis Methods Using Relational Risk Analysis

Combining relational risk analysis (ReRA) modeling strategies with hazard analysis and critical control point (HACCP) and other process flow risk analysis methods makes them more efficient.

Host Cell Protein Analysis: Immunoassays

Learn about host cell proteins (HCPs) and the sensitive and specific orthogonal methods necessary to identify individual HCP impurities that persist through DS purification processes.

Mastering Spectral Flow Cytometry: Foundational Concepts And Techniques

Discover how spectral flow cytometry enhances flexibility and resolution in high-parameter experiments. Gain practical insights on panel design, fluorochrome selection, and control strategies.

Multiparameter Characterization Of CAR-T Cells

See how innovative in vitro assays for CAR-T cells can enhance therapeutic outcomes by providing detailed insights into their properties and behaviors throughout pre-clinical and clinical development.

Triplex RT-dPCR Method For A Safety Study In Drug Development

Watch how an innovative technology harnesses natural RNA editing with EONs and digital PCR to precisely correct mutations, which offers a novel approach to treating genetic diseases.

A Case Study Of The GLP-1 Receptor Agonist, Semaglutide, In Plasma

Light scattering reveals critical insights into the structural integrity, aggregation, and stability of GLP-1 analogs, which are essential for optimizing drug formulations and improving treatments.

What Is OPC Counting Efficiency?

Ensure cleanroom air quality with optical particle counters. Explore how OPCs work, their performance metrics, and key considerations for choosing the right one.

Aseptic Environmental Monitoring For Vaccine Manufacturing

To meet immediate vaccine demand, aseptic manufacturing capacity must increase quickly. This means environmental monitoring programs must adapt rapidly as well. Thoughtful planning can help.

Best Practices For Analysis Of IVT mRNA

Find out how an automated capillary electrophoresis system provides robust and precise integrity, concentration, and size analysis for IVT mRNA.

Insights To Sustainable Signaling Devices With Bioluminescent Bacteria

A protocol for scaling a bioluminescent marine strain is validated, revealing atypical light kinetics that necessitate an immediate harvesting window for maximum performance.

A Guide To The Ultimate Product Improvement Tool

Examine how to transform your product quality review that emphasizes systematic evaluation and improvement of product quality, highlighting automation benefits through modern software.

Characterizing Binding Interactions By ITC

Isothermal Titration Calorimetry is a powerful technique for analyzing biochemical binding events, which is crucial for understanding molecular interactions and enzyme kinetics in biomedical research.

A Human-Relevant Model Of The Liver Sinusoid

This organ-on-a-chip model minimizes drug absorption while maintaining the essential architecture. Review the specifications of this product, engineered to model the human liver.

Analytical Method Release And Stability Platform For RNA Drug Substance

We offer comprehensive analytical support across the R&D space, including method development, validation, process characterization, in-process testing, process validation, and GMP release testing.

QUALITY/ANALYTICAL METHODS SOLUTIONS

How It Works: Operation Of Fragment Analyzer Systems - Agilent Technologies

High-Purity Analytical Solvents: Consistent Quality For Applicants - Greenfield Global

FOCUS ON REGULATORY

Lessons From FDA 483s And Warning Letters: Cleanroom Compliance

Learn critical lessons from FDA 483 observations and Warning Letters to proactively address common GMP cleanroom compliance failures and build an inspection-ready facility.

Taking A Best Practice Approach To Contamination Control

Implementing the EU GMP Annex 1 requires a holistic, evolutionary Contamination Control Strategy built on standardization, data analytics, and continuous improvement for a zero-defect mindset.

Optimizing Monitoring: The Science Of Particle Loss

Discover how tubing configuration impacts particle recovery and compliance under Annex 1, using evidence-based guidance, risk assessment tools, and practical strategies.

REGULATORY SOLUTIONS

Visual Inspection Of Advanced Therapy Medicinal Products - InQuest Science

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