Quality Control

INSIGHTS ON QUALITY CONTROL

Aggregate Analysis Of Semaglutide
Effective size exclusion chromatography (SEC) for Semaglutide aggregate analysis is possible without high organic solvents or acidic modifiers. Learn about this robust method for improved efficacy.
Predicting Drug-Loading Limits In Tablet Formulations
Learn how predictive percolation modeling identified critical drug-loading limits of ~20% for crystalline API and ~15% for SDD forms, cutting tablet formulation trial-and-error significantly.
503A Vs. 503B: Turning Regulatory Complexity Into Practical Compliance
Navigating human drug compounding requires aligning Section 503A and Section 503B operations with cGMP expectations, robust quality management systems, and standing inspection readiness.
Audit Trails Aren't "On/Off": How To Build A Review Program QA Can Actually Sustain
Switching on an audit trail shows awareness, not control. Inspectors look for governed review: defined scope, structured reasons for change, risk-based cadence, and named ownership of exceptions in maintenance and calibration.

Improving Bioprocess Monitoring And Control With Multivariate Data Analysis
12/9/2024

Learn about multivariate data analysis (MVDA) techniques, like PCA and PLS, that enable near real-time monitoring, prediction, and optimization of biomanufacturing processes.
The Strategic Value Of In-House Delumping For Homogeneous API Production
9/9/2026

API batch homogeneity supports efficient manufacturing. Controlled delumping improves powder flow and chargeability while maintaining particle size integrity and reducing GMP-scale risks.
Build A Culture Of Clean To Elevate Your Cleanroom
2/12/2026

Keeping your cleanroom spotless is vital for product quality and patient safety. Consider these important factors for how to build a culture of clean and how your cleanroom will benefit.
Global Regulatory Harmonization: Comparisons In Aseptic Barrier Systems
4/20/2026

Compare global aseptic standards from the FDA, EMA, PIC/S, and WHO. Gain insights into how advanced barrier systems harmonize international requirements to ensure sterile product integrity and safety.
Glucagon-Like Peptide-1 (GLP-1) Analogues Applications Notebook
12/11/2025

View this collection of application notes about the chromatographic analysis and purification of GLP-1 analogues, including Semaglutide, Tirzepatide, Liraglutide, and Exenatide.

Scaling Organometallic Chemistry With Confidence

Scaling organometallic reactions requires robust cryogenic infrastructure and precise reagent preparation. Standardized facilities support seamless tech transfer, safe scale-up, and reliable supply.
Intuitively Simple HPLC System For Biopharma

Discover the advantages of an intuitively simple HPLC system developed specifically for biopharmaceutical quality control laboratories.
Small Molecule Drug Substance: API Capabilities

Eurofins CDMO Alphora handles small molecule APIs and HPAPIs from IND-enabling through commercialization, with FDA and Health Canada-approved facilities scaling up to 125 kg per batch. Contact them to discuss your program.
The Business Case For Electronic GxP Management

Spreadsheet-based quality systems carry costs that tend to be underestimated. Electronic GxP management shifts effort from routine compliance tasks toward quality improvement and patient safety.
Cell Therapy Selection Guide: Connected From Activation To Expansion

Active bead release gives manufacturers precise control over T cell isolation timing, phenotype preservation, and workflow efficiency, eliminating multi-day passive dissociation delays.