Search results for " activity"
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
Setting Standards for Biotech Therapeutics in India
The authors take a look at the past and future impact of the Indian Pharmacopoeia Commission.
By: Anurag S. Rathore, PhD, Renu Jain, M. Kalaivani, Gunjan Narula, G. N. Singh
BioPharm Inter…
Article
The Lifecycle Change of Process Validation and Analytical Testing
All PAT applications need to have some assessment of 'is it working correctly' built in, as well as appropriate means of efficiently performing 'instrumental activity' such as maintenance and/or calib…
Article
How To Execute Successful Data Migrations
Successful migrations require careful planning to meet business needs and maintain data integrity.
By Art Meisler
Data migration is the unglamorous task of a system implementation. …
Article
Gene Therapies Push Viral Vector Production
In addition, it is important to maintain AAV vector biological activity when removing impurities and contaminates present in a feedstock that originates from host cells or culture media. Next to this,…
Article
Addressing the Complex Nature of Downstream Processing with QbD
Quality by design brings both challenges and benefits to the development of downstream processes.
By Susan Haigney
natali_mis/Stock.Adobe.com
Regulators have been en…
Article
Leveraging Computational Models of Glycosylation for Biopharma QA
Man5 may also enhance antibody-dependent cellular cytotoxicity (ADCC) (8), a mechanism that improves the oncolytic activity of mAbs.
• Tandem α-1,3 galactose is a non-human glycosylation motif tha…
Article
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
A major advantage of SPR-based analysis is its ability to estimate the association and dissociation rate constants, an …
Article
Modeling the Degradation of mAb Therapeutics
It can, either directly or indirectly, affect mAbs’ biological activity as well as toxicity (4).
The instabilities associated with mAbs can be broadly classified as either physical or chemical…
Article
The Challenge of Disruptive Technologies in Bioprocessing
The Challenge of Disruptive Technologies in BioprocessingIncreasing demand for biologics is driving the need for innovation in bioprocessing.
Jul 01, 2018
Increasing demand for biologics is drivin…