BioQC Articles | Latest Insights in Biopharmaceutical Quality

Breaking through analytical boundaries: Development of next-generation gene therapies and vaccines

Event Overview This presentation showcases advanced ELISA-MS™ as the premier technology for detailed characterisation and comprehensive coverage of Host Cell Protein (HCP) ELISA reagents. Precisely assessing HCP coverage is essential for biopharmaceutical development...

PDF download | Benefit from expert Q&A and tips & tricks in this Cell and Gene Therapy (CGT) Compendium

Meet the Expert: Mass Spectrometry for HCP Monitoring in GMP

by BioQC Video Article

AdvertisementIntroduction A conversation with Somar Khalil, Principal Scientist at GSK Vaccines, on why the industry needed to move beyond immunoassays for monitoring residual host cell proteins (HCPs), and how his team demonstrated that untargeted, label-free mass...

Watch Author Insights | GSK's Dr. Somar Khalil | Move beyond aggregate immunoassay signals and validate untargeted, label-free mass spectrometry for individual-protein HCP monitoring in a GMP setting, grounded in ICH Q2(R2).

Quality assessment of sgRNA and Cas9 mRNA for CRISPR – based therapeutics by capillary electrophoresis (CE)

by BioQC and SCIEX Application Note

AdvertisementGene editing is one of the fastest-growing areas in biotechnology and biopharmaceutical research, with CRISPR-Cas9 (clustered regularly interspaced short palindromic repeats-CRISPR-associated protein 9) leading the field as the primary method. A common...

PDF download | Assessment of sgRNA quality with single-nucleotide resolution and accurate ratio of sgRNA and Cas9 mRNA for CRISPR-based therapeutics through direct measurements with UV detection.

Meet the Expert: Method Validation in Pharmaceutical Analysis

by BioQC Video Article

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...

Watch Author Insights | Expert: Dr. 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.

Prospective ICH Q2(R2)-Aligned Total-Error Validation of Label-Free Untargeted Proteomics for Host Cell Protein Quantification in Biotherapeutics

by BioQC Article

AdvertisementThis 2026 study by Somar Khalil, Jean-François Dierick, Pascal Bourguignon and Michel Plisnier from GSK presents what the authors describe as the first prospective ICH Q2(R2)-aligned validation of untargeted proteomics for host cell protein (HCP)...

Read Article Review | Access full paper | A regulatory-oriented framework that enables advanced LC-MS/MS proteomics workflows to move closer to routine biopharmaceutical quality control.

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...

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

Rapid Platform icIEF Methods Development with AESlyte® HR 5–10.5 for Diverse mAbs

by BioQC and Advanced Electrophoresis Solutions Application Note

AdvertisementThe AESlyte Rapid Method Development Kit is designed to make developing icIEF methods for monoclonal antibodies and other biotherapeutics quicker and easier. Using AESlyte HR 5–10.5 with two default pI markers (5.72 & 9.71), the standardised workflow...

PDF download | The AESlyte Rapid Method Development Kit is designed to streamline and accelerate the creation of icIEF methods for mAbs and various biotherapeutics.

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...

Watch Author Insights | 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.