Search results for " reliability" in Articles / App Notes
Article
Understanding Validation and Technical Transfer, Part 3
Understanding Validation and Technical Transfer, Part 3
Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies. Part 1 |…
Article
Understanding Validation and Technical Transfer, Part I
Understanding Validation and Technical Transfer, Part I
This is the first of a series of three articles about validation and technical transfer in the bio-pharmaceutical industry. Part 1 || Part 2 |…
Article
Modern Manufacturing Key to More Effective Vaccines
Modern Manufacturing Key to More Effective Vaccines
Accelerated development of new preventives raises challenges for efficient CMC evaluation and production.
By Jill Wechsler
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Article
Transformative Medicines Challenge FDA and Manufacturers
Transformative Medicines Challenge FDA and Manufacturers
New gene therapies and combination products require innovative regulatory approaches.
By Jill Wechsler …
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
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
Reconciling Sensor Communication Gaps
By Angelo DePalma, Ph.D.
Process analytical technology (PAT), quality by design, and individual company- or process-centric quality initiatives are driving the development of bioprocess sensors …
Article
Platform Approach Speeds Process Development
A modular cell-culture platform demonstrates accelerated process development.
By Harald Bradl, Jan Bechmann, Benedikt Greulich, Markus Michael Mueller, Patrick Schulz, Thomas Wucherpfennig
C…
Article
Going Small to Achieve Success on the Commercial Scale
In many cases, that isn’t possible, and the feed may need to be frozen, which introduces a new variable that can impact the reliability of the model.
Specifically for chromatography operations, so…
Article
The Metrics of Quality Culture
Achieving a quality culture requires management and employees to establish an environment where responsibility, accountability, and reliability are paramount, and to understand the role each person pe…