Companies are evolving from static reports to living models by strengthening their data backbone with advanced analytics and ...
SAN FRANCISCO--(BUSINESS WIRE)--ValGenesis, Inc., the market leader in enterprise Validation Lifecycle Management Systems (VLMS), has acquired Portugal-based 4Tune Engineering (4TE), a leader in ...
This article overviews some of the benefits and methods of state-based control as it applies to the models defined by the ISA106, Procedure Automation for Continuous Process Operations standards ...
ANSI/ISA-106.00.01, Procedure Automation for Continuous Process Operations, has been published by ISA. The standard sets forth models, styles, strategies, philosophies, and life cycle for the ...
In biopharmaceutical manufacturing, consistency is vital but hard to achieve. Turning raw materials into safe, high-quality medicines requires stable processes. However, the living cellular expression ...
Technological innovations throughout the past several decades have transformed the pharmaceutical manufacturing process from traditional batch production to ...
In the context of current good manufacturing practice (cGMP), a number of pharmaceutical manufacturers are incorporating Process Analytical Technologies (PAT), Quality by Design (QbD), or Process ...
The European Medicines Agency (EMA) has finalized guidance intended to help sponsors meet the data requirements for process validation for biotechnology-derived active substances. The guidance, which ...
A photo of technicians working in front of a process train. Novartis's continuous manufacturing center in Basel, Switzerland, replicates an end-to-end manufacturing process developed at the ...
The European Medicines Agency (EMA) has released a new draft guideline on process validation that brings EMA thinking in line with the International Conference on Harmonization of Technical ...
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