Shape Up Before You Ship Out: Morphology as a Potential Critical Quality Attribute for Cellular Therapies

2021 ◽  
pp. 100352
Author(s):  
Kanupriya R. Daga ◽  
Priyanka Priyadarshani ◽  
Andrew M. Larey ◽  
Kejie Rui ◽  
Luke J. Mortensen ◽  
...  
Keyword(s):  
Quality Attribute ◽  
Critical Quality Attribute ◽  
Cellular Therapies

A Scale-up Approach for Film Coating Process Based on Surface Roughness as the Critical Quality Attribute

2018 ◽  
Vol 19 (3) ◽  
pp. 1243-1253 ◽  
Author(s):  
Hiroyuki Yoshino ◽  
Yuko Hara ◽  
Masafumi Dohi ◽  
Kazunari Yamashita ◽  
Tadashi Hakomori ◽  
...  
Keyword(s):  
Surface Roughness ◽  
Scale Up ◽  
Film Coating ◽  
Coating Process ◽  
Quality Attribute ◽  
Critical Quality Attribute

scholarly journals NONDESTRUCTIVE FIRMNESS MEASUREMENT OF KIWIFRUIT

HortScience ◽  
1992 ◽  
Vol 27 (6) ◽  
pp. 599b-599
Author(s):  
Judith A. Abbott ◽  
D. R. Massie
Keyword(s):  
Data Processing ◽  
Resonance Frequency ◽  
Vibrational Spectra ◽  
Storage Time ◽  
Maximum Force ◽  
Dynamic Force ◽  
Quality Attribute ◽  
Critical Quality Attribute ◽  
Resonance Frequencies ◽  
Highly Correlated

Firmness is a critical quality attribute for kiwifruit, as it is for most commodities. Firmness is related to flesh elasticity and rigidity which, along with geometry and density, determine vibrational behavior. Firmness changes in kiwifruit were followed during storage at 0C by three methods: sonic vibrational spectra from 0 to 2000 Hz, dynamic force/deformation (F/D) in the range 40 to 440 Hz, and Magness-Taylor puncture (MT) on an Instron. Frequencies of sonic resonances and dynamic F/D peaks, as well as MT maximum force, decreased as storage time increased. Sonic resonance frequencies were highly correlated with MT maximum force and apparent elasticity (r=0.79 and 0.88). Frequencies of peaks in the dynamic F/D traces were correlated with MT maximum force and apparent elasticity (r=0.68 and 0.72) and with resonance frequency (r=0.81). Further data processing improves the ability of the nondestructive vibrational measurements to estimate the destructive MT test values.

Effects of sialic acid linkage on antibody-fragment crystallizable receptor binding and antibody dependent cytotoxicity depend on levels of fucosylation/bisecting

Bioanalysis ◽  
2019 ◽  
Vol 11 (15) ◽  
pp. 1437-1449 ◽  
Author(s):  
Marco Thomann ◽  
Sebastian Malik ◽  
Felix Kuhne ◽  
Cecile Avenal ◽  
Friederike Plath ◽  
...  
Keyword(s):  
Sialic Acid ◽  
Receptor Binding ◽  
Antibody Fragment ◽  
Quality Attribute ◽  
Fcγ Receptor ◽  
Critical Quality Attribute ◽  
Cytotoxicity Activity ◽  
Terminal Galactose ◽  
The Impact ◽  
Different Levels

Aim: Fragment crystallizable (Fc) glycosylation of immunoglobulin G-type monoclonal antibodies applied to therapeutic applications is regarded a critical quality attribute and can influence bioactivity, pharmacokinetics and/or immunogenicity/safety. Investigating the impact of certain Fc N-glycans is therefore of importance to assess its criticality for a therapeutic product. This has been done for N-glycan types like fucosylation, galactosylation or sialylation. There were contradictory results reported for functionality especially with regard to sialylation. Material & methods: We elucidated the effect of terminal sialic acid residues on Fcγ receptor binding and antibody dependent cytotoxicity activity of two immunoglobulin G1 antibodies with different levels of fucosylation/bi-secting. Conclusion: We found the impact to be specific to the sialylation linkage type, in other words, α2,3- versus α2,6-linked sialic acid attached to the terminal galactose residues

scholarly journals Best practices in bioassay development to support registration of biopharmaceuticals

BioTechniques ◽  
2019 ◽  
Vol 67 (3) ◽  
pp. 126-137 ◽  
Author(s):  
John R White ◽  
Marla Abodeely ◽  
Sammina Ahmed ◽  
Gaël Debauve ◽  
Evan Johnson ◽  
...  
Keyword(s):  
Biological Activity ◽  
Best Practices ◽  
Mechanisms Of Action ◽  
Point Of View ◽  
Relative Potency ◽  
Quality Attribute ◽  
Critical Quality Attribute ◽  
Statistical Approaches ◽  
And Control

Biological activity is a critical quality attribute for biopharmaceuticals, which is accurately measured using an appropriate relative potency bioassay. Developing a bioassay is a complex, rigorous undertaking that needs to address several challenges including modelling all of the mechanisms of action associated with the biotherapeutic. Bioassay development is also an exciting and fast evolving field, not only from a scientific, medical and technological point of view, but also in terms of statistical approaches and regulatory expectations. This has led to an industry-wide discussion on the most appropriate ways to develop, validate and control the bioassays throughout the drug lifecycle.

scholarly journals Development and optimization of the activated charcoal suspension composition based on a mixture design approach

2015 ◽  
Vol 65 (1) ◽  
pp. 83-90 ◽  
Author(s):  
Joanna Ronowicz ◽  
Bogumiła Kupcewicz ◽  
Łukasz Pałkowski ◽  
Jerzy Krysiński
Keyword(s):  
Activated Charcoal ◽  
Marked Decrease ◽  
Drug Product ◽  
Mixture Design ◽  
Design Approach ◽  
Prognostic Models ◽  
Quality Attribute ◽  
Optimal Composition ◽  
Critical Quality Attribute ◽  
Selection Of

Abstract In this study, a new drug product containing activated charcoal was designed and developed. The excipient levels in the pharmaceutical formulation were optimized using a mixture design approach. The adsorption power of the activated charcoal suspension was selected as the critical quality attribute influencing the efficacy of medical treatment. Significant prognostic models (p < 0.05) were obtained to describe in detail the interrelations between excipient levels and the adsorption power of the formulation. Liquid flavour had a critical impact on the adsorption power of the suspension. Formulations containing the largest amount of liquid flavour showed the lowest adsorption power. Sorbitol was not adsorbed onto activated charcoal so strongly as liquid flavour. A slight increase in the content of carboxymethylcellulose sodium led to a marked decrease in adsorption power. The obtained mathematical models and response surface allowed selection of the optimal composition of excipients in a final drug product

scholarly journals Glycoengineering Chinese hamster ovary cells: a short history

2021 ◽  
Author(s):  
Roberto Donini ◽  
Stuart M. Haslam ◽  
Cleo Kontoravdi
Keyword(s):  
Chinese Hamster Ovary ◽  
Rapid Growth ◽  
Cho Cells ◽  
Chinese Hamster Ovary Cells ◽  
Chinese Hamster ◽  
Quality Attribute ◽  
Short History ◽  
Critical Quality Attribute ◽  
Future Directions ◽  
Ovary Cells

Biotherapeutic glycoproteins have revolutionised the field of pharmaceuticals, with new discoveries and continuous improvements underpinning the rapid growth of this industry. N-glycosylation is a critical quality attribute of biotherapeutic glycoproteins that influences the efficacy, half-life and immunogenicity of these drugs. This review will focus on the advances and future directions of remodelling N-glycosylation in Chinese hamster ovary (CHO) cells, which are the workhorse of recombinant biotherapeutic production, with particular emphasis on antibody products, using strategies such as cell line and protein backbone engineering.

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