Search results for " productivity" in Articles / App Notes

Article Milestones and Moderate Progress in 2012 Drug Approvals
First gene therapy and plant-based expression vector products approved in 2012. In terms of product approvals, the past year can be considered reasonably successful. Twelve biopharm…

Article A Plastic Pipeline for Commercial Bioprocessing?
“Improvements in cell line and process development have led to increased protein productivity, which enables many biologics to be manufactured in increasingly smaller vessels. These advancements will …

Article Evaluating E&L Studies for Single-Use Systems
Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials. By Irene Cecchini, Daniele Mastroianni, Silvia Rocchi, Gabriella Angiuoni Biop…

Article Setting Standards for Biotech Therapeutics in India
The authors take a look at the past and future impact of the Indian Pharmacopoeia Commission. By: Anurag S. Rathore, PhD, Renu Jain, M. Kalaivani, Gunjan Narula, G. N. Singh BioPharm Inter…

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
Factors such as increased productivity and titer, coupled with increased market competition due to products coming off patent, has led to some stainless-steel facilities becoming underutilized and end…

Article Being Thorough When Transferring Technology
Another challenge is a high amount of dissolved CO2 in culture, if not managed carefully, can lead to high osmolality and cessation of cell growth or productivity. Additionally, non-physiological diss…

Article Biosimilars to Drive Modern Manufacturing Approaches
Reliable, high-quality products require innovative analytics and production. By Jill Wechsler As more biosimilars gain market approval in the United States, and manufacturers launch addition…

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