The complex nature of biologics creates challenges for GMPs in sterile manufacturing, and the EU’s Annex 1 is making an impact.

GMPs for Sterile Manufacturing of Biologics

FDA is incentivizing drug manufacturers through higher data integrity requirements.

Data Integrity as Current Good Manufacturing Practice

Establishing a quality culture from the top of an organization down to each and every employee ensures a safe and effective product, and saves costs.

A Robust Quality Culture Benefits All

Topic

Julie Tilbury is a collection network liaison at Be The Match BioTherapies.

Articles

Document integrity is critical in the provision of raw materials for cell and gene therapy manufacturing.

Real-Time Post-Apheresis Documentation Decreases Errors

Grant Playter is the Assistant Editor for 

Looking back at the biologics and large molecule drugs approved by FDA in the past year can give us hints toward what will be approved in the future.

Novel Therapies of 2022

WHO has awarded prequalification to GSK’s Mosquirix, an approved malaria vaccine.

WHO Grants Prequalification to GSK’s Malaria Vaccine

 Washington Editor, jillwechsler7@gmail.com.

FDA is in jeopardy of losing its fees for assessing and approving new drugs and medical products.

FDA In Limbo as User Fee Renewal Stuck on Capitol Hill

Manuela Gottschall is Head of Risk and Project Management, Global Quality at Roche.

Marie Schommer is Quality Manager at Roche Diagnostics GmbH.

Federico Colombari is Quality Risk Management Specialist at Roche.

A Post Approval Change (PAC) to replace identity (ID) testing of incoming liquid drug substance with ID by visual inspection is considered a low risk provided questioned listed in this example have been answered favorably. In that case the PAC can be downgraded from a prior approval to a notification to health authorities, and managed in the PQS with immediate implementation effect.

1VQ Solutions: Replace Identity (ID) Testing of Incoming Liquid Drug Substance with ID by Visual Verification

Lynparza has been approved in Great Britain as an adjuvant treatment for patients with germline BRCA-mutated HER2-negative high-risk early breast cancer.

Lynparza Approved in Great Britain

Sanofi’s Xenpozyme (olipudase alfa-rpcp) is now the only approved treatment for acid sphingomyelinase deficiency.

FDA Approves Novel ASMD Treatment from Sanofi

A Post Approval Change (PAC) in size of thermal shipping solution used for transport of product is considered a low risk provided it has been qualified and temperature monitored, and therefore can be downgraded from a prior approval to a notification to health authorities, and managed in the PQS with immediate implementation effect.

Industry 1VQ Solutions:  Change in Size of Thermal Shipping Solution Used for Transport of Product 

FDA has issued an emergency use authorization for both the Pfizer-BioNTech and Moderna bivalent COVID-19 boosters.

FDA Authorizes Bivalent COVID-19 Boosters

Sílvia Helena Cestari de Oliveira is researcher in the biotechnology division at Cristália Produtos Químicos Farmacêuticos, Itapira, Brazil.

Marcos Castanheira Alegria is R&D director at Hypera Pharma.

Marco Antonio Stephano is professor at the University of Sao Paulo, Sao Paulo, Brazil.

This article introduces the requirements for a biosimilar license in Brazil and addresses questions about their quality, safety, and efficacy.

Quality/GMPs

GMPs for Sterile Manufacturing of Biologics

Data Integrity as Current Good Manufacturing Practice

A Robust Quality Culture Benefits All