Search results for " efficiency"
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
An approach for establishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment.
A critical quality attribute (CQA) has been defined as “a physical, chemical, …
Article
Q&As with Industry Leaders
Discovering the unknown: How does in silico process development change PD scientists’ work?
Jeanne Linke Northrop, BioPharm International
Nora Ketterer, Manager, Modeling Services…
Article
Biopharma Takes a Nervous Glance Over Its Shoulder
Changes are needed to maintain US biopharma innovation leadership.
The US biopharmaceutical industry’s status as the global leader in innovative biopharmaceutical R&D is not guaranteed. Both…
Article
Q&A with Industry Leader Konstantin Konstantinov, Genzyme Vice-President
This week we speak with Konstantin Konstantinov, Genzyme Vice-President Late Stage Process Development, about developments in continuous processing.
Q: You’re part of an upcoming sym…
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Design of Experiments for Analytical Method Development and Validation
Design of experiment is a powerful development tool for method characterization and method validation.
Design of experiments (DOE) is a well-proven characterization approach within product…
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Outsourcing Trends in Biopharmaceutical Manufacturing
Over the past decade, BioPlan has found that developing regions, including China, India, and Brazil, as well as the substantial investments in technologies that improve productivity and efficiency are…
Article
Predicting Progress in Protein Aggregation
Techniques to enable the design and formulation of stable, protein-based therapeutics.
In silico analysis and the evaluation of formulability, aided by new analytical tools such as hydrogen deut…
Article
Best Practices in Adopting Single-Use Systems
Conclusion
Choices made when specifying single-use equipment can have cascading and lifecycle-long effects on process throughput, cost, efficiency, and risk. Adopting disposable bioprocessing by ju…
Article
FDA Seeks Metrics to Define Drug Quality
Manufacturing standards are considered key to preventing drug recalls and shortages.
Critical drug shortages and contaminated compounding of sterile injectables have heightened public concern a…
Article
Essentials in Establishing and Using Design Space
Knowledge of product or process acceptance criterion is crucial in design space.
Design space is generally considered to be the areas where the product or process parameters can be run safe…