Search results for " drug"
Article
Quality by Design and Extractable and Leachable Testing
Feb 01, 2015
By Anthony Grilli
BioPharm International
Biopharmaceutical packaging performs several vital functions in assuring the drug product safety. First and foremost, packaging must b…
Article
Continuous Manufacturing: A Changing Processing Paradigm
…ceutical companies and contract organizations building or expanding biotechnology facilities to make drugs in innovative ways. BioMarin and Vertex also plan to incorporate elements of continuous proc…
Article
Essentials in Quality Risk Management
Quality risk management (QRM), as defined in International Conference on Harmonization's (ICH) Q9 document (1), is designed to ensure that drug critical quality attributes (CQAs) are defined and maint…
Article
Setting Standards for Biotech Therapeutics in India
In India, the Drug Controller General of India (DCGI)-led Central Drugs Standards Control Organization (CDSCO) together with the State Authorities are primarily responsible for ensuring the quality of…
Article
ADC Development Robust Despite Lackluster Performance
The target for ADCs has primarily been cancer, and the cytotoxic agents that are used in ADCs are typically more potent than currently used anti-cancer drugs (1).
The ADC construct combines a t…
Article
Establishing Acceptance Criteria for Analytical Methods
Little, PhD
To control the consistency and quality of pharmaceutical products, analytical methods must be developed to measure critical quality attributes (CQAs) of drug substance/drug product. An…
Article
Process Development: What May Lie Ahead in 2018?
What have 2017 developments taught us, and what may lie ahead for biopharmaceutical drug developers and process engineers? Here, we look at some of the most popular Process Development Forum articles …
Article
Contract Manufacturing Through the Years
…has served the bio/pharmaceutical industry have been years of momentous growth and change in the way drugs are discovered, developed, manufactured, and sold. Contract development and manufacturing or…
Article
Evaluating E&L Studies for Single-Use Systems
Regulatory guidelines require that the product contact items “shall not be reactive, additive, or absorptive” to assure drug product quality and safety (2). The manufacturer is, therefore, responsible…
Article
Reimagining Affordable Biosimilars
Furthermore, developing this class of drugs is expensive and time consuming. Costs range from approximately $500 million to $3 billion, and development takes more than a decade, the majority of which …