Search results for " potency" in Articles / App Notes
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
Techniques for Improving Process Development for Exosome-Derived Therapeutics
This tolerance can lead to greater potency and enhance unique tropisms, such as migration to tissues including the lymph nodes and pancreas that previously have been difficult to reach with traditiona…
Article
Reducing Cross-Contamination Risks in Process Chromatography
…hy systems are used in particular for the production of biologic drug substances with high cytotoxic potency, such as antibody-drug conjugates (ADCs), according to Morelli. In Lundström’s experience,…
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
Conclusion
Surface cleanliness is crucial in ensuring that process residue, cleaning agent residue, and bioburden do not adversely affect the safety, quality, and potency of the drug manufactured.…
Article
From Darwin to Recombinant Fc Multimers
At PPB 2017, Bosques presented data from preclinical studies and how the drug candidate M230 has demonstrated greater efficacy and 10–40 times greater potency than IVIg in three different animal model…
Article
Fusion Proteins Pose Manufacturability Challenges
“In particular, the level of N-acetylneuraminic acid or sialylation, which can impact plasma half-life and the potency of the candidate, is a key quality attribute and can be challenging to control wi…
Article
Biacore Concentration and Ligand-Binding Analyses
In this white
paper, the use of Biacore for active concentration measurements, target binding, and Fc receptor (FcR) analysis is reviewed along with the use of these assays for assessment of drug po…
Article
Cleaning of Dedicated Equipment: Why Validation is Needed
This article discusses cleaning validation of equipment dedicated to the production of a single API.
By Cristina Baccarelli, Paola Bernard, Teresa Cortellino, Oscar Cruciani, Rita Pacello, Chi…
Article
Robust Optimization, Simulation, and Effective Design Space
The effective design space is the region where no OOS events occur and/or the applicant will adjust to correct for processing conditions, raw material potency, and/or dose or formulation requirements.…
Article
Taking a “Development-by-Design” Approach to Cell Therapies
Have the end in mind
Such things as formulation issues, dosage potency, impurities, residuals, and microbial assurance need to be thought out clearly from the start, Hampson says, as well as indic…