Search results for " cost"
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
The challenge for manufacturers is to meet the requirements of the guidelines in a cost effective manner, for legacy products.
BioPharm: Overall, how has the FDA process validation guidance chan…
Article
A Look Ahead at BioPharma Manufacturing and Regulation
With this higher level of product quality, the product failure rate is expected to drop, which in turn, will increase product availability, and reduce product cost. Therefore, by focusing on these sci…
Article
Quality by design for biotechnology products—part 1
It then addresses how to incorporate QbD into a regulatory filing and finally, how to facilitate efficient, cost-effective commercial processes and manufacturing change flexibility post licensure. Alt…
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…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
… that it is a similar ionizing radiation technology to gamma irradiation yet has a lower electricity cost.
X-ray irradiation has been well-recognized as a sterilization method, with a site intend…
Article
Under pressure: exploring root causes of leaks in single-use mixers
Equipment failures in large-scale bioprocess can be costly in terms of material loss and downtime. For large manufacturers, a batch failure (i.e., one that causes product loss) can cost millions of do…
Article
From Bottlenecks to Breakthroughs: Mastering Buffer Management
- Considerations for calculating the cost of different buffer intensification approaches and impact on sustainability goals.
- A case study presented by Johnson & Johnson Innovative Medicine to sh…
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…