Search results for " extractables"
Article
Nurturing Knowledge from Disparate Data Streams
Leveraging vast quantities of analytical data requires digitalization and platform integration.
By Cynthia A. Challener
jijomathai/stock.Adobe.comAnalytical instrument…
Article
Supply Chain Challenges for Single-Use Systems
With new requirements for extractables and other testing, the time associated with the assessment and qualification of changes is increasing, which makes it more challenging to manage supply risks thr…
Article
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Analytical exoglycosidases are transitioning from being largely academic tools to being s…
Article
The Challenge of Disruptive Technologies in Bioprocessing
The Challenge of Disruptive Technologies in BioprocessingIncreasing demand for biologics is driving the need for innovation in bioprocessing.
Jul 01, 2018
Increasing demand for biologics is drivin…
Article
Biopharma Seeks Balance
For example, industry groups championed efforts to address technical issues related to materials specifications and extractables and leachables, helping to accelerate the adoption of single-use system…
Article
Industry Adoption of Single-Use Systems Remains Low
Single-use technologies are starting to gain ground as capacity needs change, but industrywide adoption remains low.
By Feliza Mirasol
zli…
Article
Preclinical Evaluation of Product Related Impurities and Variants
Preclinical Evaluation of Product Related Impurities and Variants
The approaches for sample preparation of preclinical evaluation of safety and efficacy are addressed taking into consideration the s…
Article
Best Practices for Data Integrity
Best Practices for Data Integrity
Optimize practices and meet requirements using electronic data integrity systems.
By Jennifer Markarian
Maintainin…
Article
The New World of Biopharmaceutical Manufacturing
Top concerns are the potential for breakage of bags/loss of production materials and leachables and extractables (L&E) issues. Part of this persistent concern for L&E issues is the increased use of di…
Article
Unifying Continuous Biomanufacturing Operations
Also, Klutz and team admitted the single-use equipment they used in the paper was meant for fed-batch, so no analysis of extractables and leachables was conducted; this analysis would typically be a n…