Pharmaceutical Technology

AUGUST 2, 2022

GreenLight’s process from formulation of the drug substance and lipid nanoparticle to bulk drug product can be carried out in this facility. The RNA platform of Samsung Biologics permitted GreenLight to move from mRNA vaccine conceptualisation to the delivery of released clinical trial material in under two years.

Engineering 104

Engineering Manufacturing Pharmaceutical 104

European Pharmaceutical Review

JANUARY 29, 2024

1 Some five years after the initial NDMA (N-nitrosodimethylamine) contamination issue 2 initially affecting valsartan drug substance, then other active pharmaceutical ingredients (APIs), eg, sartans, ranitidine, metformin, etc; the toxic short alkyl chain N-nitrosamine issue appears, if not resolved, then well on the way to resolution.

Pharmaceutical 105

Pharmaceutical Food and Drug Administration Medicine FDA 105

European Pharmaceutical Review

SEPTEMBER 25, 2023

This has led to applications with biopharmaceutical formulations and protein investigations. Of particular interest is the potential of using NMR relaxometry as a point of receipt technique to satisfy regulatory identity testing requirements for active pharmaceutical ingredients (API) and drug product materials.

Pharmaceutical 98

Pharmaceutical Manufacturing Food Electronics 98

Pharmaceutical Technology

APRIL 21, 2023

Samyang Holdings Biopharm Division CEO Young-Joon Lee stated: “LG Chem has exceptional research and development expertise in innovative drug development and a number of promising new drug pipelines. This is expected to shorten the development time of new drugs and to support personalised treatments.

Patients 52

Patients Leads Pharmaceutical 52

European Pharmaceutical Review

OCTOBER 5, 2023

What are the key topics you plan to cover during your session at CPHI Barcelona? I firmly believe that manufacturing plays a pivotal role in this endeavour, and I will delve into topics such as production system optimisation and the standardisation of chemistry, manufacturing, and control (CMC) processes.”

Manufacturing 93

Manufacturing Consulting Patients Marketing 93

PM360

DECEMBER 14, 2023

The downside to this potent drug is it can be quite toxic and poses risks to the human body even in small doses. Some commonly unknown topics touched upon are how sound reaches the brain, what noise-induced hearing damage looks like, and how tinnitus really affects the ear. What does hearing loss look like?

Healthcare 52

Healthcare Healthcare FDA Education 52

European Pharmaceutical Review

JANUARY 25, 2024

Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. Ophthalmic drug products should be evaluated for extractables and leachables, FDA asserted.

FDA 95

FDA Food and Drug Administration Safety Manufacturing 95

European Pharmaceutical Review

OCTOBER 2, 2023

Building on its legacy of excellence, this year’s event promises to unite suppliers, innovators, and pharma professionals in an exceptional setting, combining the best of in-person and online experiences. CPHI creates connections and inspires partnerships across the global pharma community. Credit: CPHI What’s new for 2023?

Manufacturing 103

Manufacturing Pharma Engineering Networking 103