BioQC Articles | Latest Insights in Biopharmaceutical Quality

Comprehensive method development for a wide size range of RNA

AdvertisementThe integrity and quality of the encapsulated nucleic acids used in cell and gene therapy are important to ensure the efficacy and safety of the therapeutic product. Current methods used to characterise the integrity and quality of these nucleic acids are...

PDF download | This work introduces a new chemistry and methods optimisation strategy that is applicable to singlestranded RNAs, with lengths ranging from 50 to 9000 bases, to achieve high-resolution and high-quality data.

Separation of virus-like particles and nano-emulsions for vaccine development by Capillary Zone Electrophoresis

by BioQC Video Article

AdvertisementIntroduction Vaccine formulations increasingly incorporate virus-like particles (VLPs) along with nano-emulsion adjuvants to boost immune responses. However, analytically characterising these mixtures is very difficult because both components are...

Watch Author Insights | Merck's Dr. Adam Sutton | Learn practical strategies for developing and validating a single CZE method capable of simultaneously characterising nanoparticles, surfactants, and small molecules in multi-component pharmaceutical formulations.

Automated Capillary Electrophoresis (CE) workflow for high-resolution RNA integrity analysis

by BioQC and SCIEX Application Note

AdvertisementHigh-resolution characterisation of RNA integrity, size distribution, and degradation patterns is essential across modern molecular biology and biopharmaceutical workflows, from mRNA-LNP therapeutics to gene expression studies and viral genomics....

PDF download | This automated workflow minimises variability in sample and reagent preparation, prevents RNase contamination, and ensures consistent CE performance across high-throughput batches.

A Comprehensive Evaluation of Analytical Method Parameters Critical to the Reliable Assessment of Therapeutic mRNA Integrity by Capillary Gel Electrophoresis

by BioQC Video Article

AdvertisementIntroduction Messenger RNA (mRNA)-lipid nanoparticle (LNP) therapies are an innovative biopharmaceutical approach with quickly adaptable production methods. However, evaluating their quality requires specific analytical techniques that consider the unique...

Watch Author Insights | Health Canada's Dr. Huixin Lu | Understand how key method parameters, including denaturant type, LNP disruption strategy, and sample preparation, critically influence mRNA integrity results measured by CGE-LIF.

Universal Study Design for Instrument Changes in Pharmaceutical Release Analytics

by BioQC Video Article

AdvertisementIntroduction Introduces a universal study design to assess comparability when switching or updating pharmaceutical analytical instruments, ensuring compliance with GMP requirements. Demonstrates the approach with a benchmark study comparing ICE3 and...

Watch Author Insights | Boehringer Ingelheim's Dr. Anne Ries | Explore a practical benchmark example comparing two icIEF instruments, and gain a reusable framework to support lifecycle management of analytical methods in regulated environments.

Advancing Reversed-Phase Chromatography Analytics of Influenza Vaccines Using Machine Learning Approaches on a Diverse Range of Antigens and Formulations

by BioQC Video Article

AdvertisementIntroduction Reversed-phase chromatography is a vital tool in influenza vaccine analysis, yet optimising methods for difficult separations - like strain co-elution or excipient interference - has traditionally depended on manual interpretation and analyst...

Watch Author Insights | Health Canada's Dr. Huixin Lu | Discover how machine learning can automate the classification of reversed-phase chromatograms for influenza vaccines, reducing reliance on manual interpretation and accelerating method development.

A Practical Approach to Implementing ICH Q14: Tools for Analytical Quality by Design in Capillary Electrophoresis Method Development

by BioQC Video Article

AdvertisementIntroduction Practical, stepwise implementation of ICH Q14 using AQbD tools Full method lifecycle approach: from Analytical Target Profile (ATP) and technology selection to control strategy and lifecycle management Efficient application of Design of...

Watch Author Insights | BioQC's Dr. Ewoud van Tricht | Discover how capillary electrophoresis, developed using Design of Experiments, can replace slower techniques like qPCR for adenovirus quantification, cutting analysis time from days to under an hour.

Analytical Method Comparability Studies: Expert Panel Discussion on Instrument and Technology Changes

by BioQC Summary

Advertisement This summary accompanies a recent expert forum discussion organised by BioQC. We appreciate the panellists’ time and expertise. The views expressed by the panellists are their personal interpretations and do not represent the positions of their...

Panel Q&A | PDF download | Understand the practical distinctions between comparability, equivalence, and equality in the context of analytical method transitions, and learn how to frame study objectives and acceptance criteria accordingly.