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Fill/Finish Challenges for COVID-19 Vaccines

Liquid and lyophilized forms and preparing for the large capacity present challenges.

Emergent BioSolutions Hit with FDA Form 483

April 21, 2021

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

Emergent BioSolutions Pauses Vaccine Manufacturing

April 19, 2021

Pending a completed FDA inspection, Emergent BioSolutions halts manufacture of vaccine drug substance at Maryland facility.

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.

J&J to Take Over Its Product Manufacturing at Emergent Facility

April 05, 2021

Following a manufacturing mix-up, J&J will extend its oversight at Emergent’s Maryland facility; AstraZeneca manufacturing to relocate.

Supply Chain Challenges Creating Hurdles to COVID-19 Vaccine Production

April 01, 2021

The availability of materials is a critical factor when it comes to vaccine capacity.

SGS Facilitates Phase I Study of ImmTOR in Gene Therapy

March 30, 2021

SGS is supporting Selecta Biosciences and Asklepios BioPharmaceutical with the Phase I dose-escalation trial of SEL-3999, an AAV8 vector capsid containing no transgene with ImmTOR.

Toxicology: Ensuring Drugs are Safe for People

March 01, 2021

Accelerated drug development timelines must accommodate all crucial elements of nonclinical safety studies.

SPT Labtech Strengthens Automation Services with BioMicroLab Acquisition

March 01, 2021

The acquisition strategically expands SPT Labtech’s offering in sample management for life sciences.

Avid Bioservices Expands Biologics Manufacturing Capacity

February 22, 2021

The second phase of the Myford facility expansion in California will add upstream and downstream processing suites.

Novavax Expands COVID-19 Collaboration and License Agreement with SK Bioscience

February 17, 2021

The companies have expanded their existing partnership to include 40 Million Doses of COVID-19 vaccine for South Korea.