Search results for " approval"
Article
Reliability Rooms and the Move to Proactive Supply Chain Management
This is based on a supply chain that can deliver these new products to customers following regulatory approvals and in the committed timeframe.
As RRs develop, they remain centered around four k…
Article
Roadmap Leads to Innovative Biomanufacturing Strategies
As a regulated industry, any solution will have to meet regulatory approval before it can be implemented.
Roadmap benefits
BioPharm: What are the major benefits of this roadmap?
Beri (Lon…
Article
Platform Technologies Improve Protein Expression
Regulatory approval of the STEP technology is expected in 2018 at the latest, according to Havenga, with first products on the market using STEP in 2024.
Plant-based expression
Ventria Bio…
Article
Development and Future of Protein A Chromatography Technology: Q&A with Jonathan Royce, Business Leader Chromatography Resins, Cytiva
This week Process Development Forum talks about Protein A with Jonathan Royce, business leader for Cytiva chromatography resins.
mAb purification platforms are very well established, and …
Article
Avoiding Investigational Failures and Discrepancies
Other investigation-centered benefits of EQMS software solutions include:
Automated routing, notification, delivery, escalation, and approval of CAPAs and all related documentation
…
Article
Critical Quality Attributes Challenge Biologics Development
BioPharm: What is the process for determining risk, specifically for biologics?
Das (BMS): Risk assessment is an evolving process from the discovery phase to clinical stages to product approval an…
Article
Single-use Bioreactors Have Reached the Big Time
The decision to use disposable bioreactors is now driven by commercial rather than technological considerations.
By Cynthia A. Challener
Single-use bioreactors available from various vendors…
Article
Managing Risk in Raw Material Sourcing
Vendor selection and materials testing are complex enough, but in today’s volatile environment, risk mapping and monitoring are also crucial.
By Agnes Shanley
Choosing excipients and supplie…
Article
Improving Process-Scale Chromatography
Advances in technology are increasing the productivity and efficiency of commercial-scale chromatography bioprocesses.
By Cynthia Challener, PhD
Chromatography is a crucial step in the purif…
Article
Design and Qualification of Single-Use Systems
The author provides a review of the concepts of design and qualification that apply to single-use systems.
By Jerold M. Martin
Single-use technologies (SUT) have made significant inroads in …