BioQC Articles | Latest Insights in Biopharmaceutical Quality

Meet the Expert: Method Validation in Pharmaceutical Analysis

AdvertisementIntroduction A conversation with Joachim Ermer on Method Validation in Pharmaceutical Analysis: A Guide to Best Practice, now in its third edition. Joachim shares what motivated him to write it, how it's structured, and why moving beyond a checklist...

Meet the expert: Joachim Ermer | Move beyond checkbox compliance and master the full analytical lifecycle, from method design to routine verification, with purpose-driven validation grounded in ICH Q2 and Q14.

Improvement of Peak Integration in Capillary Electrophoresis: Reference Data Set No. 1

by BioQC Video Article

AdvertisementIntroduction As biopharmaceuticals grow in complexity, traditional peak integration algorithms are increasingly struggling to keep pace, particularly in Capillary Electrophoresis (CE), where intricate sample profiles expose the limits of conventional...

Marlon Krompholz | Explore the variability of manual peak integration and discover evidence-based strategies to improve analytical reproducibility.

Peak Integration of Electropherograms in GMP and Research Labs: Navigating Increased Scrutiny Amid Data Integrity Audits and Inspections

by BioQC Video Article

AdvertisementIntroduction Capillary electrophoresis (CE) offers superior separation for complex biologics like monoclonal antibodies, but its irregular baselines and broad, asymmetric peaks make peak integration far more challenging than chromatography—especially in...

Meet the Expert: Dr. Timothy Blanc | Explore the current lack of regulatory guidance for electropherogram integration and discover how industry-wide harmonisation of guidelines, benchmarks, and software could strengthen analytical reliability.

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...

Meet the Expert: 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.

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...

Meet the Expert: 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...

Meet the Expert: 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...

Meet the Expert: 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.

ICH Q14: Guideline Overview for Analytical Procedure Lifecycle Management

by BioQC Article

AdvertisementThe ICH Q14 guideline, formally part of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), represents a step forward in ensuring that analytical methods for pharmaceuticals are scientifically...

Gain Valuable Regulatory Insights | Obtain a clear overview of the ICH Q14 guideline and understand how its lifecycle management framework integrates method development, validation, and continual improvement into a cohesive, science-based approach.