Quality/GMPs

Navigating the Intricacies of Lentiviral CGTs

Scientists are leveraging ddPCR technology to get an accurate read on viral titer and vector copy number.

Complying with Compendial Requirements; Image: Leigh Prather - stock.adobe.com

Using a Third Party to Perform Audits

There are key elements that should be covered when dealing with third-party auditors, according to Siegfried Schmitt, vice president, Technical, at Parexel.

FDA Inspections Face Overhaul

The agency will be reorganizing field force and compliance functions.

New Biologic Treatment for Hidradenitis Suppurativa Receives FDA Approval

November 03, 2023

This is the second biologic approved to treat HS, a painful and reoccurring skin disease.

European Commission Searches for Committee Experts

November 03, 2023

The EC is calling for interested parties for their safety and orphan drug committees.

ATCC and USP Launch Six Products Used to Detect Residual Host Cell Genomic DNA

November 03, 2023

According to USP, the products will advance quality and reduce risk in the development and manufacture of biologics and vaccines.

Remembering Raw Material Basics for mAb Production

November 02, 2023

Re-evaluating the basics of mAb production may be beneficial for the biopharma industry as a whole.

Paring Down Impurities in Downstream Processing

November 01, 2023

USP offers strategies to minimize residual impurities in downstream processing.

FDA Provides Guidance on Remote Facility Evaluations

November 01, 2023

The guidance describes the agency’s procedures for performing remote interactive evaluations at drug manufacturing and bioresearch monitoring facilities.

Using a Third Party to Perform Audits

November 01, 2023

There are key elements that should be covered when dealing with third-party auditors, according to Siegfried Schmitt, vice president, Technical, at Parexel.

FDA Approves Vaccine for Prevention of the Five Most Common Serogroups Causing Meningococcal Disease in Adolescents

October 30, 2023

PENBRAYA combines components from two meningococcal vaccines, Trumenba and Nimenrix.

EMA Creates Mechanism for Support during Drug Shortages

October 25, 2023

The agency’s solidarity mechanism allows Member States to support each other when there is a shortage of a critical medicines.

FDA Finalizes Guidance on Development of COVID-19 Vaccines

October 24, 2023

The final guidance document was issued to assist bio/pharma companies in the clinical development and licensure of COVID-19 vaccines.