Compliance Contamination Contract Manufacturing Marketing 
Roots Analysis
APRIL 15, 2024
Additionally, the fill finish manufacturing of biologics is a critical step in the production of biopharmaceuticals as it requires well-equipped facilities with adequate sterile filling and packaging lines to ensure sterility of the product while filling into the final containers.
FDA Law Blog
JANUARY 1, 2024
The FDA compliance data, sorted by category, shows there were 159 Warning Letters issued to drug manufacturers or sponsors during 2023, with 161 issued in calendar year 2022. market complaints in 2021 through 2023 but could not provide documentation to demonstrate how the complaints were reviewed or evaluated. Terragene S.A.,
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Roots Analysis
JANUARY 12, 2023
The key steps involved in the supply chain of cell therapies manufacturing are presented below. However, there are several hurdles associated with the transition of cell-based therapy products from laboratory to clinical scale, such as regulatory compliance, lack of advanced facilities and infrastructure.
The Pharma Data
NOVEMBER 15, 2020
Prior to Celgene, she held leadership roles in marketing, sales and new business development from 2002 to 2011 at Johnson & Johnson. She earned a BA from Durham University, U.K., and an MBA from Harvard Business School. Most recently, she was a senior executive at Celgene Corporation, where she led corporate strategy from 2012 to 2017.
Pharmaceutical Technology
JUNE 14, 2023
The number of high-potency drug approvals has increased over the last decade, driven by the increasing use of APIs (Active Pharmaceutical Ingredients) in the pipeline and among marketed drugs. Containment challenges and opportunities High containment facilities guard against exposure to extremely potent products and cross-contamination.
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