02.27.24 -- Getting Generic Drugs Right: FDA Revises ANDA Guidance

Leveraging computer-aided synthesis design technology and route scouting in the early stages of development can aid you in designing an efficient and cost-effective path to API manufacturing.

Explore the reasoning behind the increasing demand for cleanroom technology as well as the advantages modular cleanroom design brings to the sterile processing of complex therapies.

More than 80% of NCEs are poorly soluble compounds. Overcoming this challenge using lipid nanoparticles is essential to move your drug product through the pipeline and into the market.

Do you want to develop an oral controlled release (OCR) product? Understanding the options and their ramifications is the first step toward devising a plan.

A variety of concerns -- underscored by supply chain disruptions driven by the COVID-19 pandemic -- are pushing companies to redraw global supply chains to resume more domestic manufacturing.

Watch this presentation to equip stakeholders with actionable strategies and a comprehensive understanding of the evolving clinical trial management landscape in the context of ICH guidelines.

Review study findings on a validated LC–MS/MS method for quantifying copanlisib from a mouse dried blood spot and its potential for enabling desirable sensitivity, accuracy, and precision.

The term "dark factory" represents an innovative approach to production that promises increased efficiency, quality, and safety. Explore the hurdles manufacturers face when implementing a dark factory.

Explore solutions to common quality, market demand, supply, and international manufacturing challenges faced when bringing new therapeutics to market.

Learn how formulating an orally disintegrating tablet (ODT) created a convenient dosage form with a shorter T_max for the treatment of acute migraine.

This study worked to determine if the chosen vial-stopper-seal combination will remain integral while frozen at -80°C when the appropriate materials, processing, and sealing conditions are applied.