Search results for " production"
Article
Milestones and Moderate Progress in 2012 Drug Approvals
Glycoprotein production in plant-based systems generally results in the formation of hyperglycosylated product containing various sugar moieties immunogenic in man. The sugar chains are devoid of sial…
Article
A Plastic Pipeline for Commercial Bioprocessing?
Adoption for commercial production has been slow; however, as more therapies developed under single-use processes move toward regulatory approval, industry experts expect the percentage of biologic-ba…
Article
Evaluating E&L Studies for Single-Use Systems
It is presumed that any impurity entering the production stream can have a negative impact on the product quality and the severity of such a failure mode is considered to be high. A process-specific a…
Article
Setting Standards for Biotech Therapeutics in India
In this 31st article in the “Elements of Biopharmaceutical Production” series, the authors report on the evolution and future of IPC. The focus of the article is on biotech therapeutics.
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Article
Reimagining Affordable Biosimilars
Advances in preclinical development play a crucial role in reducing cost for developing biosimilars.
By Anurag S. Rathore, Narendra Chirmule, and Himanshu Malani
Drug development is …
Article
Establishing Acceptance Criteria for Analytical Methods
Knowing how method performance impacts out-of-specification rates may improve quality risk management and product knowledge.
By Thomas A. Little, PhD
To control the consistency and quality o…
Article
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
From a CMO perspective, the traditional strategy behind process development has largely been to quickly identify target operational values that hit a primary quality target. This type of development s…
Article
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
By Peter Genest, John Joseph
The benefits of adopting single-use technologies in the production of biopharmaceuticals, such as lower capital investment and increased flexibility, are now well docu…
Article
Being Thorough When Transferring Technology
Thus, you want to use a feed profile at the bench or pilot scale that will translate to the production scale.
Lonza: When scaling up mammalian processes from lab scale to commercial, the decline p…
Article
Biosimilars to Drive Modern Manufacturing Approaches
FDA officials are emphasizing how advanced analytical methods can document product performance similar to a reference drug, and that cutting-edge technology can ensure reliable production of high-qual…