Search results for " data interpretation"
Article
Evaluating E&L Studies for Single-Use Systems
• Many artifacts and analytical interferences were generated by strong/reactive solutions (as NaOH/NaClO), causing difficulties in the analyses and data interpretation; the use of strong saline/reacti…
Article
The Affordable Care Act's Impact on Innovation in Biopharma
The biopharmaceutical industry contemplates product innovation within the changing landscape of healthcare.
The Affordable Care Act (ACA) has elicited intense national debate and sent biopharm…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle.
T…
Article
Being Thorough When Transferring Technology
Communication and taking the time to develop the process are key to successful transfer and scale up of biologics.
By Susan Haigney
Editor's note: The following is an extended version of the…
Article
The Metrics of Quality Culture
FDA’s proposed guidance for quality metrics raises questions about quantifying the tangibles and intangibles of quality culture.
By Andrew Harrison, Susan J. Schniepp
The long awaited, anxio…
Article
Quality by design for biotechnology products—part 1
A PhRMA Working Group's advice on applying QbD to biotech.
By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta,…
Article
Elucidating Biosimilars Characterization
The global market for biosimilar drugs has been forecasted to be $2.445 billion in 2013 according to a report by the British market-research firm, Visiongain (1). The growth corresponds to a …
Article
Reimagining Affordable Biosimilars
Advances in preclinical development play a crucial role in reducing cost for developing biosimilars.
By Anurag S. Rathore, Narendra Chirmule, and Himanshu Malani
Drug development is …
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…
Article
An Analytical Approach to Biosimilar Drug Development
In addition to simplifying data interpretation, it allowed for blinded study sample analysis without doubling the number of samples analyzed. The single assay approach became the standard in the indus…