Search results for " validation" in Articles / App Notes
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
…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Haury, “Applications of Failure Modes and Effects Analysis to Biotechnology Manufacturing Processes” in Process Validation in Manufacturing of Biopharmaceuticals, A.S. Rathore and G. Sofer, Eds.) Tayl…
Article
Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
Smith also notes that the adoption of single-use manufacturing technology accelerates process validation and analytical testing for Novavax’s vaccines and may allow for ultimate regulatory approval of…
Article
Biopharma Outsourcing Activities Update
Outsourcing activity remains strong and unlikely to abate, especially in more traditional areas.
Over the past 11 years, BioPlan’s annual report and survey of biopharmaceutical manufacturing ha…
Article
Outsourcing Trends in Biopharmaceutical Manufacturing
Beyond typically outsourced activities like fill-finish, validation services, and assays, companies are increasingly relying on their suppliers to address more challenging processes. From expertly pac…
Article
Predicting Progress in Protein Aggregation
Techniques to enable the design and formulation of stable, protein-based therapeutics.
In silico analysis and the evaluation of formulability, aided by new analytical tools such as hydrogen deut…