Search results for " costs"
Article
Regulatory Challenges in the QbD Paradigm
This decline in success rate, along with the increasing scrutiny of healthcare costs in developed economies, has resulted in unrelenting pressure on the pharmaceutical companies to control drug-develo…
Article
The Lifecycle Change of Process Validation and Analytical Testing
In the two years since the publication of FDA's final process validation guidance, how has this new lifecycle approach affected the way the industry performs validation? BioPharm Internati…
Article
A Look Ahead at BioPharma Manufacturing and Regulation
The FDA talks about the changing scope of regulatory science.
Regulatory science underpins innovation and practices in drug manufacturing. The most common definition of r…
Article
Quality by design for biotechnology products—part 1
… optimization can pave the way for less frequent dosing, increased efficacy, decreased manufacturing costs, and an improved safety profile.5–10
Using Laboratory, Nonclinical, and Clinical Studies…
Terms of Use
…uccessors, officers, directors and employees) harmless from and against any and all claims, demands, costs, liabilities, judgments, losses, expenses and damages (including attorneys' fees) arising ou…
Article
Sterilization Trends for Single-Use Consumables
Single-use (SU) technologies increasingly find use today at all phases of the drug development cycle from preclinical to commercial manufacturing. As the biopharmaceutical market continues to …
Article
Under pressure: exploring root causes of leaks in single-use mixers
Single-use technology offers huge benefits for both flexibility and efficiency. It reduces downtime by eliminating cleaning steps, helps avoid risk of cross-contamination, and enables modulari…
Article
From Bottlenecks to Breakthroughs: Mastering Buffer Management
Unlock innovation in manufacturing by optimizing your buffer production.
Agenda
- Options to intensify buffer preparation from using pre-made buffers or buffer concentrates to impl…
Webcast
Webinar: Building an Innovative Integrated Continuous Downstream Manufacturing Platform for the Production of Biologics
About this talk
Full title: Building an Innovative Integrated Continuous Downstream Manufacturing Platform for the Production of Biologics Presented by Irina Ramos, Director, Bioprocess Technology and…
Article
Explore ÄKTA pilot 600 in 3D
Cost and speed are critical components in biomanufacturing. See how ÄKTA pilot™ 600 supports scale-up from process development to GMP clinical scale.
Explore this ÄKTA™ system in…