Search results for "quality" in Articles / App Notes
Article
Challenges in Analytical Method Development and Validation
The manufacture of biopharmaceuticals presents some unique challenges when ensuring product quality and patient safety. Analytical testing can provide the data needed to produce a safe and effective d…
Article
The Affordable Care Act's Impact on Innovation in Biopharma
Impact of Shifting Risk
With the ACA’s endorsement of ACOs, there is a clear emphasis on shifting risk associated with the quality and costs of healthcare to the provider. The focus on the ACO mod…
Article
Best Practices in Adopting Single-Use Systems
Numerous technical advances have contributed to the attractiveness of single-use equipment across the range of production scales, such as improvements in materials and quality of construction a…
Article
PDA's Technical Report for Biotech Cleaning Validation
LeBlanc
ABSTRACT
Quality by Design principles such as design space can also be applied to cleaning validation. As discussed in the recently published PDA Technical Report No. 49: Points to Consi…
Article
Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
“Proper training for operators on proper procedures and immersing them in the quality mindset is foundational,” he insists. “Investment in employee satisfaction and career development can help keep tu…
Article
Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
Balancing critical process parameters against competing requirements for critical quality attribute (CQA) specifications. We also touch upon continuous versus batch manufacturing.
Topics…
Article
Strategizing for Rapid Changeovers in Biologics Manufacturing
With the changing industry tide favoring multiproduct manufacturing facilities, methods to enhance efficiency without sacrificing quality or safety are needed,” he says.
Several activities must be…
Article
Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
Raw material quality control (QC) testing can also be reduced or eliminated by implementing single-use technologies, saving time from reduced process steps as well as labor costs.
The increa…
Article
Mapping a Route for Cell and Gene Therapy Process Development
The additional steps aim to increase the quality of the product, but may also reduce the quantity,” he observes.
Similar process development challenges
Early processes developed for cell ther…
Article
Leveraging Computational Models of Glycosylation for Biopharma QA
Due to its bioprocess-associated variability and impact on safety, pharmacokinetics, and pharmacodynamics, glycosylation is widely regarded as a critical quality attribute (CQA) of TGPs (1).
In th…