Search results for " validation"
Article
Ensuring the Quality of Biologicals
standards have a role during the development of biosimilars as they are used for method qualification and validation. Where biosimilars have been approved for use in the European Union, there are corr…
Article
Modular Manufacturing Platforms for Biologics
…h a pod is replicated, we would always recommend to clone the system to reduce the qualification and validation burden.”
Current modular facilities
While there are numerous examples of facili…
Article
Continuous Chromatography: Trends, Definitions and Approaches
Process Development Forum speaks with Karol Lacki, Customer Collaborations Leader at Cytiva, about continuous chromatography.
There is a lot of attention being paid to continuous chromat…
Article
USP Publishes Monoclonal Antibody Guidelines
Mar 02, 2015
By Dale Schmidt, M.S., Anita Y. Szajek, PhD, Fouad Atouf, PhD, Tina S. Morris, PhD
BioPharm International
Volume 3, Issue 28
As FDA gears up towards approving biosimilar dru…
Article
Vaccine Development and Production Challenges Manufacturers
Mar 01, 2015
By Jill Wechsler
BioPharm International
Volume 3, Issue 28
Vaccines are front-page news these days. Researchers are advancing new vaccines for Ebola and other devastating di…
Article
Detecting Protein Aggregates and Evaluating their Immunogenicity
Mar 01, 2015
By Randi Hernandez
BioPharm International
Volume 3, Issue 28
Aggregation in biopharmaceuticals remains a major concern and threatens the stability of a product. Protein …
Article
SEC in the Modern Downstream Purification Process
The low-cost/low-complexity use of SEC resins in single-use technologies would be ideal to alleviate growing economic concerns and would reduce costs by eliminating some of the validation expenses ass…
Article
Ligand-Binding Assays and the Determination of Biosimilarity
…similars Action Program Committee published a whitepaper with recommendation for the development and validation of ligand-binding assays for PK assessments (2). Sadick notes that the AAPS whitepaper …
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
Application of Quality by Design to Viral Safety
A quality-by-design approach defines a range of potential viral contaminants of source materials and can be used to effectively achieve viral clearance.
Oct 1, 2014
BioPharm International
…