Pharmaceutical Technology
Dec 31, 2010 · Pharmaceutical Technology is the independent source for information, insight, and analysis on bio/pharmaceutical formulation, development, and manufacturing.
Pharmaceutical Technology - PharmTech
Pharmaceutical Technology is the independent source for information, insight, and analysis on bio/pharmaceutical formulation, development, and manufacturing.
The Basics of Aseptic Processing - PharmTech
Oct 2, 2021 · Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about aseptic processing.
Validating Pharma 4.0 for Smart Manufacturing
Sep 19, 2024 · The drug manufacturing ecosystem Pharma 4.0, a term coined in 2017 by the International Society for Pharmaceutical Engineers, promises a revolution across drug discovery, manufacturing, and supply chain logistics, ensuring drugs are delivered precisely when needed, and improving overall patient care.
FDA Releases Draft Guidance on Sampling and Testing of In …
Jan 3, 2025 · FDA published a draft guidance document on Jan. 2, 2025 that provides considerations for complying with 21 Code of Federal Regulations (CFR) 211.110 (1).This specific section of the CFR focuses on production and process controls for sampling and testing of in-process materials and drug products.
Exploring Opportunities for LNP Delivery in mRNA
Dec 7, 2024 · Lipid nanoparticles (LNPs) have been gaining traction as a primary formulation and drug delivery tool in the manufacture of messenger RNA (mRNA)-based therapeutics, having proven their utility in the development of mRNA COVID-19 vaccines.
Industry Outlook for 2025—Real-World Data - pharmtech.com
Dec 27, 2024 · The use of real-world data (RWD) and real-world evidence (RWE) has become a focus of pharmaceutical regulators in recent years. In December 2024, FDA’s Center for Drug Evaluation and Research announced a new Center for Real-World Evidence Innovation that will coordinate and promote the use of these data in regulatory decision making (1).
Leveraging Advancements in Bioanalytical Testing
Dec 5, 2024 · It is well-known that developing a drug from the discovery through to commercialization is a costly endeavor, with market analysis showing that the average R&D cost to develop an asset for 2022–2023 was $2.3 billion (1).
Lilly and Amgen Each Announce Major Expansions of US …
On Dec. 5, 2024 both Eli Lilly and Company (Lilly) and Amgen announced their plans to expand their manufacturing facilities in Kenosha County, Wis., and Holly Springs, NC, respectively.
Integrating Advanced Technologies for Pharma Analysis
Dec 8, 2024 · Use of process analytical technology (PAT) and advanced digital solutions such as artificial intelligence (AI) and machine learning (ML) is a crucial component of the move to Pharma 4.0.