Search results for " stability" in Articles / App Notes
Article
DoE Provides Benefits, but Preparation Is Necessary
Obtaining relevant data
In most DoE formulations studies, data related to the critical quality attributes and the stability of the API, such as the protein melting temperature, secondary or tertia…
Article
Single-Domain Antibodies for Brain Targeting
Thus, human single domains would be preferable for in-vivo applications provided problems of poor stability and solubility can be overcome.
Crystal and solution structures of several sdAbs adopt a…
Article
Unifying Continuous Biomanufacturing Operations
…ould eliminate scale-up altogether; test the consequences of continuous lines on product quality and stability; and consider what vendor gaps exist that could preclude a completely end-to-end continu…
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
Poor stability of monoclonal antibodies outside their natural environment, however, is one of the major challenges in product development (2–6). A number of non-optimal formulation, manufacturing, or …
Article
Quality by design for biotechnology products—part 1
A number of strategies are currently used by investigators to alter the properties of the molecule to achieve the desired balance among efficacy, stability, safety (such as immunogenicity), and manufa…
Article
Reviewing the Importance of Biosimilarity and Interchangeability
Among these criteria are comparability, biological activity, impurity assessment, and stability studies, Stamm notes. He explains that, for comparability, the biosimilar needs to demonstrate similarit…
Article
Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
…achable profiles of single-use systems and tanks)
Freezing points and temperature stability of solutions (necessary to mitigate issues post-shipping).
A simple failur…
Article
Can Vaccine Development Be Safely Accelerated?
Can Vaccine Development Be Safely Accelerated?
Biopharma companies responding to the COVID-19 outbreak think accelerating the development of vaccines is safe.
By Cynthia A. Ch…
Article
Emerging Therapies Test Existing Bioanalytical Methods
Assay validation includes evaluation of intra- and inter-assay precision and accuracy, specificity and selectivity, limit of detection, and stability. Expression of the gene therapy product should als…
Article
A Look at the Affinity Chromatography Landscape
To meet this need, in 2017 the company developed a new Protein A ligand that offers both greater caustic stability (up to 1 molar sodium hydroxide) and increased binding capacity for monoclonal antibo…