Search results for " sourcing" in Articles / App Notes
Article
Patenting Prospects for Cell-Based Therapies
Cell-based therapies are moving medical treatments forward, but intellectual property uncertainties may delay progress.
By Kevin Noonan
Treatment using cell-based therapies is a rapidl…
Article
Avoiding Investigational Failures and Discrepancies
Avoiding Investigational Failures and Discrepancies
Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.
By Walt Murray,…
Article
Unifying Continuous Biomanufacturing Operations
The success of a truly integrated continuous processing platform relies on the collaborative efforts of upstream and downstream specialists.
By Randi Hernandez
When human cells travel throug…
Article
Fusion Proteins Pose Manufacturability Challenges
The unique structures of fusion proteins lead to expression, heterogeneity, and stability issues.
By Cynthia A. Challener
Fusion proteins are engineered proteins that contain domains from di…
Article
Being Thorough When Transferring Technology
Communication and taking the time to develop the process are key to successful transfer and scale up of biologics.
By Susan Haigney
Editor's note: The following is an extended version of the…
Article
Evaluating E&L Studies for Single-Use Systems
Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
By Irene Cecchini, Daniele Mastroianni, Silvia Rocchi, Gabriella Angiuoni
Biop…
Article
Drug Quality Key to Innovation and Access
Expanded global sourcing of pharmaceutical ingredients and products will continue to build support for regulatory mutual reliance initiatives able to streamline agency oversight while assuring quality…
Article
The Tide Stays High
Robust venture capital investment gives CDMOs and CROs a positive outlook for 2017.
By Jim Miller
A year ago, the outlook for contract services was a little uncertain. Equity markets’ appeti…
Article
Establishing Acceptance Criteria for Analytical Methods
Knowing how method performance impacts out-of-specification rates may improve quality risk management and product knowledge.
By Thomas A. Little, PhD
To control the consistency and quality o…
Article
Modeling Bioreactor Performance
Model effectiveness is determined by the quality and composition of the data inputs.
By Cynthia A. Challener
Bioreactor design, including the geometry of the tank and impeller and the locati…