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View More Analytical Methods BioBusiness Cell Culture/Fermentation Continuous Processing Drug Delivery Fill/Finish Formulation Process Chromatography Process Control/PAT Process Development QA/QC Separation and Purification Single-Use Systems Supply Chain

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Quality/GMPs

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Conducting Effective Audits

Planning and the proper use of technology facilitate effective remote auditing.

It Takes a Bio/Pharma Village

Precompetitive efforts demonstrate that collaboration is essential to serve patients.

Biden Seeks Added Funding for Medical Research and Disease Tracking

April 21, 2021

The White House sent Congress a summary of “topline” funding requests that continue efforts to combat the coronavirus pandemic and to restore the nation’s economic health.

Emergent BioSolutions Hit with FDA Form 483

April 21, 2021

Post-inspection report reveals nine sanitary and process problems at Bayview, Md., facility.

FDA Shuts Down Emergent Vaccine Facility

April 20, 2021

FDA has called a halt in production of vaccine drug substance and to quarantine all remaining product at the Bayview plant.

FDA Revokes Emergency Use Authorization for COVID-19 Treatment

April 19, 2021

The agency revoked EUA status for the monoclonal antibody bamlanivimab to be administered alone to treat mild-to-moderate COVID-19.

Hyalo Technologies Unveils Room Temperature Drug-Stabilizing Technology

April 15, 2021

This new technology could eliminate the need for cold chain storage, transport, and distribution of temperature-sensitive molecules.

Leadership Change at CDER Spotlights Imperative to Name New FDA Commissioner

April 14, 2021

Patrizia Cavazzoni will become the director of the Center for Drug Evaluation and Research, and Janet Woodcock remains in limbo as the temporary head of FDA.

FDA Recommends Pausing Use of J&J COVID-19 Vaccine After Reports of Blood Clots

April 13, 2021

CDC and FDA are reviewing data from reported cases of a rare type of blood clot in people that received the Johnson & Johnson COVID-19 vaccine.

FDA Inspectors Cited Critical Problems at Emergent Facility

April 09, 2021

Even before Emergent disclosed that it had to discard 15 million doses of the J&J vaccine drug substance, FDA inspectors had uncovered multiple deficiencies and quality control issues.

Fluid Handling Systems are Seeing Benefit from Single-Use Technologies

April 01, 2021

The adoption of single-use technologies in fluid-handling systems helps streamline downstream bioprocessing operations.

Stability Testing of Protein Therapeutics Using DLS

April 01, 2021

Dynamic light scattering presents a good analytical technique for testing protein stability.