Quality/GMPs

Manufacturing Process Robustness

A structured assessment process can determine compliance for lifecycle process validation.

Environmental Controls Reduce Bioburden; image: SIARHEI - STOCK.ADOBE.COM

Controlling Conditions to Reduce Disinfectant Need

Controlling certain atmospheric conditions in a closed cell system can reduce bioburden.

Sinovac’s Eupolio Vaccine Gains Market Authorization in China

July 23, 2021

Sinovac Biotech’s Eupolio vaccine, a Sabin inactivated poliovirus vaccine (sIPV), has gained marketing authorization in China.

EC Grants Marketing Authorization for bluebird bio’s Gene Therapy SKYSONA

July 23, 2021

The European Commission has granted marketing authorization to bluebird bio for its gene therapy SKYSONA for the treatment of early CALD.

Samsung Biologics Partners with Kineta for Anti-VISTA Antibody Immunotherapy

July 21, 2021

Samsung Biologics and Kineta have entered into a strategic partnership for drug product manufacturing services and to support an IND filing of a novel antibody therapeutic.

Complex Biomolecules Require Analytical Evolution

July 16, 2021

The ever-increasing complexity of biotherapeutic molecules presents unique analytical challenges for developers.

Data Integrity Considerations for Vendor-Generated Data Associated with Analytical Testing

July 16, 2021

Sponsors should consider best practices for maintaining data generated during sample analysis and instrument maintenance.

EMA Concludes There is No Link Between Zynteglo and AML

July 15, 2021

EMA's safety committee, PRAC, has concluded that there is no evidence linking the viral vector in Zynteglo to a blood cancer known as acute myeloid leukemia (AML).

EMA Advises Against Using Janssen’s COVID-19 Vaccine in People with Capillary Leak Syndrome

July 15, 2021

After a review of three cases, EMA's PRAC has advised against the use of Janssen’s COVID-19 vaccine in people who have a history of capillary leak syndrome.

PRAC Finds Link to Very Rare Cases of Myocarditis and Pericarditis with Comirnaty and Spikevax

July 15, 2021

EMA's PRAC has found a possible link to very rare cases of myocarditis and pericarditis after vaccination with Comirnaty and Spikevax COVID-19 vaccines.

Prioritizing Cleaning Validation

July 15, 2021

As recent COVID-19 vaccine facility citations make clear, failure to meet cleaning and sanitization requirements puts patients, facilities, and operators at risk.

Drug Prices Targeted in Biden Competition Initiative

July 14, 2021

White House proposal includes measure to make drugs more affordable.