Finished Product Analysis

Building Data Quality in Generates Quality Data Out

March 02, 2020

BioPharm International

Ensuring the quality of data in process monitoring and control systems starts in process development phases.

Cell and Gene Therapies Necessitate New Lot Release Test Methods

November 01, 2019

BioPharm International

Accelerated timelines and small batch volumes of cell and gene therapies pose unique challenges for product-release testing.

Test Methods and Quality Control for Prefilled Syringes

March 01, 2019

BioPharm International

Both empty and filled syringes must pass a range of tests to meet quality standards for biopharmaceutical drugs.

Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs

October 01, 2018

BioPharm International

Analytical exoglycosidases are transitioning from being largely academic tools to being suitable for glycan analytics in biopharmaceutical manufacturing.

Expectations for Residual Impurity Analysis Continue to Rise

August 01, 2018

BioPharm International

More complex biologic samples must be evaluated to ever higher levels of specificity and sensitivity.

Improving Visual Inspection

April 01, 2018

BioPharm International

RGtimeline/Shutterstock.comParenteral product quality is improving.

Stability Testing Ensures Proper Packaging for Drug Storage

January 01, 2018

BioPharm International

Conducting stability testing on APIs/finished drug product helps ensure shelf-life storage.

Stakeholders Comment on FDA Draft Guidance for Evaluating Biosimilarity

December 05, 2017

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

The Challenges of PAT in the Scale-Up of Biologics Production

October 01, 2017

BioPharm International

Process analytical testing for biopharmaceuticals requires enhanced methods due to complex bioprocesses.

Optimizing Protein Aggregate Analysis by SEC

October 01, 2017

BioPharm International

A UHPLC SEC approach for protein aggregate analysis of mAbs is presented.