Search results for " QbD"
Resource
DiPIA 2021 virtual conference
Real science, real interactions, real time
For the first time ever, the DiPIA conference will virtually connect you with researchers around the globe.
Get inspired by leading experts in academ…
Article
A Stepwise Approach to a Digital Transformation in Biopharma
Click here to read more >>
An interview on “smart” manufacturing—a paradigm shift towards digital transformation for improved safety and quality, optimized performance, and increased complianc…
Article
Track-and-Trace Progress Benefits Supply-Chain Security Efforts
By Agnes Shanley
The industry has made great strides in implementing serialization technologies, while technology developers are enabling more open access to real-time transportation data.
S…
Article
How to Optimize and Scale Up AAV Production
In this article from a roundtable discussion, four experts from academia and industry met to discuss challenges in refining and scaling up AAV production pipelines to meet the increasing demand for …
Article
Single-Use Technologies Prove Effective for Viral Vector Process Development
The benefits of single-use technologies for upstream viral-vector processes clearly outweigh their disadvantages.
Cynthia A. Challener
Upstream viral-vector processes can have sig…
Article
Setting Up Bioprocessing Systems for Digital Transformation
Digitalization of bioprocessing operations, equipment, and facilities can improve workflow and output, but maintaining data integrity is a concern.
By Feliza Mirasol
The advancement of digit…
Article
Process Development: Go Smarter, Go Faster! Available on Demand
Did you miss our virtual symposium? We heard from leaders at GlaxoSmithKline, Byondis, UCB, UCL, GoSilico, and Cytiva on how they balance innovation, speed, and robustness to accelerate their p…
Article
FDA Provides Guidance on Bispecific Antibody Development Programs
The final guidance document provides recommendations for regulatory, quality, nonclinical, and clinical considerations for bispecific antibody development programs.
FDA published final guidance …
Article
Regulatory Requirements for Safe and Efficient Biologic Drug Development
STEVE
Click here to view more Industry Leader Q&As >>
Steven Lynn, Executive Vice-President, Pharmaceuticals, Regulatory Compliance Associates, shares insight into regulatory require…
Article
Traceability in Western Blot Imaging: Considerations for GxP
LEARN MORE >>
Densitometry analysis of gels is a key part of quality control in the pharmaceutical drug release process. In regulated environments, electronic record-keeping can improve both tra…