Search results for " process"
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
With the most recent FDA (1) and Inter-national Conference on Har-monization (ICH) guidances (2-4) advocating a new paradigm of process validation based on process understanding and control of paramet…
Article
QbD and PAT in Upstream and Downstream Processing
UPSTREAM PROCESSING
BioPharm: In implementing QbD, what would you identify as the critical quality attributes (CQAs) in a typical upstream bioprocess using cell-culture?
Vanden Boom (Hospi…
Article
Continuous Manufacturing: A Changing Processing Paradigm
…, managing partner, BioPlan Associates—are manufactured through perfusion or continuous downstream processing, the field is evolving (1). Most of these processes are done piecewise, however, and are …
Article
The Lifecycle Change of Process Validation and Analytical Testing
BioPharm International spoke with Hal Baseman, COO and principal at ValSource LLC and co-leader of the Parenteral Drug Association Process Validation Interest Group; Paul Smith, EMEAI laboratory compl…
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Mapping a Route for Cell and Gene Therapy Process Development
Challener
The regenerative medicine field is still quite young, and companies developing commercial processes for the production of cell and gene therapies face several hurdles. These product…
Article
Assessing Manufacturing Process Robustness
ICH guidelines Q8–Q12 (1–5) and those in development such as ICH Q14 (6) have applied science, risk management, and quality systems to enhance process and product quality.
In 2011, …
Article
Single-Use Technologies Prove Effective for Viral Vector Process Development
Challener
Upstream viral-vector processes can have significant impacts on downstream purification requirements. The presence of serum, culture harvest viability, turbidity, cell lysis r…
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Achieving Process Balance with Perfusion Bioreactors
The differences in processing conditions for batch and perfusion cell culture lead to different requirements for bioreactors used for these processes. Equipment suppliers are responding to needs for m…
Article
Continued Process Verification for Biopharma Manufacturing
48-52
Continued process verification (CPV) is the activity that provides ongoing verification of the performance of a manufacturing process. Guidance issued by FDA in 2011 (1) emphasized the impo…
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Science Focus Fuels Successful Process Development for Startups
They lack access to revenue streams from existing drug sales to fund their process development efforts, so money must be raised, which requires convincing investors that the ideas they are developing …