Search results for " manufacturing"
Article
State of the Biopharmaceutical Industry: Lessons from 2018 Survey Data
of Rockville, MD, has surveyed developers of biotherapeutics and contract manufacturing organizations working in this space about current and projected capacity and production. The results, published …
Article
FDA Framework Spurs Advanced Therapies
ISCT also expects the recent approvals to spark considerable investment across all stages of drug development from fundamental research within academia to commercial manufacturing by Big Pharma and co…
Article
Best Practices in Qualification of Single-Use Systems
Figure 1 depicts a typical monoclonal antibody (mAb) drug manufacturing process. Single-use bioreactors are widely used in cell line expansion, and the use at production scale is increasing, notably i…
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FDA Seeks Metrics to Define Drug Quality
Seeking metrics
In crafting the shortages plan, an FDA Drug Shortages Task Force has been examining more broadly how drug manufacturing problems may precipitate plant closings and product discontin…
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Sterilization Trends for Single-Use Consumables
As the biopharmaceutical market continues to expand and reliance on single-use manufacturing rises, demand for SU consumables—bags, containers, filters, tubing, etc.—is also increasing. The value of t…
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Digitalization: The Route to Biopharma 4.0
It is evident that there is an urgent need to incorporate digital solutions at initial stages of process development, manufacturing, and quality assurance (QA).
Digitalization in pr…
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The Outlook for CMO Outsourcing in 2019
Rader
Biopharmaceutical industry-related indicators and trends are supporting continued incremental increases in outsourcing of pre- and commercial API and biopharmaceutical product ma…
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Evaluating E&L Studies for Single-Use Systems
for manufacturing processes, in addition to multi-use (MU) materials (i.e., glass bottles, stainless steel tanks, etc.) (1). Regulatory guidelines require that the product contact items “shall not be …
Article
Advancing Single-Use Technology Through Collaboration
By Cheryl Zigrand
The use of disposable, single-use components within the biopharmaceutical manufacturing process is not a new phenomenon. Silicone tubing, capsule filters, tissue culture flasks, …
Article
Perfusion in the 21st Century
By Bruce Lehr, Delia Lyons
Cell-culture technology for biopharmaceutical manufacturing has steadily advanced over the past three decades. Batch processing, in which all raw materials are introduce…