Search results for " safety"
Article
Defining Risk Assessment of Aseptic Processes
…ing it are properly maintained at all times to avoid product contamination that would impact patient safety.
Developing a risk-based approach
The first step in developing a risk-based approac…
Article
Establishing Acceptance Criteria for Analytical Methods
Generally, to control the quality of a product and to manage drug safety and efficacy, there are two key elements: cinical trials evaluting the pharmacokinetics (PK) response to drug product and dose …
Poster
Unlocking the potential for efficiency in downstream bioprocesses
In today's bioprocessing industry, there is a demand to cut manufacturing costs while maintaining product safety and quality. Additionally, flexibility needs to be increased and time to market reduc…
Article
A Q&A on Bioprocessing Trends and Technologies at INTERPHEX 2016
…d approach to evaluating single-use system components and conduct supplemental testing to ensure the safety of their process systems.
Did you see any trends in the consumables segment?
The qu…
Article
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Asking the right questions is crucial to establishing a facility design.
By Peter Genest, John Joseph
The benefits of adopting single-use technologies in the production of biopharmaceuticals…
Article
Vaccine Development Faces Urgency and Challenges
Meanwhile, testing continues on Ebola vaccine candidates that have produced evidence of safety and efficacy from “emergency use” and initial clinical studies. Merck announced advanced clinical trials …
Poster
Biacore™ systems in vaccine development and production
… and more flexible manufacturing principles to increase production efficiency while assuring vaccine safety and efficacy.
Article
Going Small to Achieve Success on the Commercial Scale
Unlike initial processes that are used during the discovery and early development phases to produce material for characterization, efficacy, safety, and other studies, scale-down models are intended t…
Article
Tools for Continuous Bioprocessing Development
These variations are translated into a set of design rules, which help ensure that designs will be manufactured successfully and meet safety and other regulatory requirements.
The ability to codify…
Article
Biopharma in 2015: A Year for Approvals and Innovations
Biosimilars have an exemplary safety track record in the EU, Japan, and Canada. The EU was the first geographic market to develop the process of authorization of biosimilars, setting an example for ma…