Search results for " glycosylate"
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
Cell-free Expression Systems Pose Cell Culture Alternative
Cell-free expression is promising in preclinical applications, but still presents challenges to scale up for commercial production.
Feliza Mirasol
Among the challenges in upstrea…
Article
Reimagining Affordable Biosimilars
Each glycosylated variant of the antibody can have different biological effects with respect to efficacy and safety. Thus, the complexity of biologics makes it near-impossible to study the effect of e…
Article
What’s in your media? How costly is variability of cell culture media to your manufacturing process?
Manufacturing
In this video, Christopher Woolstenhulme, Lead Analytical Scientist of Manufacturing Sciences at Cytiva, is interviewed by BioPharm International and provides insight into t…
Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
While the multiple attributes method gains ground and traditional lab methods improve, broad efforts are underway to determine biopharmaceuticals’ most significant critical quality attributes and en…
Article
Unifying Continuous Biomanufacturing Operations
The success of a truly integrated continuous processing platform relies on the collaborative efforts of upstream and downstream specialists.
By Randi Hernandez
When human cells travel throug…
Article
Digitalization: The Route to Biopharma 4.0
Industry 4.0, also known as the Fourth Industrial Revolution (4IR), will result in the digital transformation of the manufacturing sector. It is propelled by transformative trends such as the prolif…
Article
Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
Spivey and Lane
Click here to view more Q&As >>
Analytic considerations for upstream processing – covering Process Analytic Technology (PAT), time-savings versus off-line ana…
Article
Impurity Testing of Biologic Drug Products
…ht when the therapeutic protein does not present any major challenge for ionization (such as heavily glycosylated proteins)
• Amino-acid analysis and extinction coefficient estimation
…
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…