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. Summaries of the most striking recently released Warning Letters are included below. Dextrum Laboratories Inc. Dextrum Laboratories Inc.
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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
a publicly traded biopharmaceutical company, from 2012 to December 2019, managing its international, legal, quality, intellectual property and compliance functions, after serving in other executive roles at Acorda starting in 2004. Before joining Acorda, Ms.
Pharmaceutical Technology
JUNE 14, 2023
Containment challenges and opportunities High containment facilities guard against exposure to extremely potent products and cross-contamination. Many small and mid-cap companies lack the expertise for regulatory compliance and high containment facilities and thus seek to outsource NMEs (New Molecular Entities) requiring special handling.
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