Search results for " drug"
Article
Use of Multivariate Data Analysis in Bioprocessing
… innovator and their biosimilar version, the regulatory authorities may consider the approval of the drug for market authorization with minimal clinical studies data.
A quantitative approach has be…
Article
Ensuring the Quality of Biologicals
The monographs are based on licensed specifications (for the drug substance or finished product) backed up by batch data.
Additionally, the Ph. Eur. monographs are supported by a large number of g…
Article
Re-use of Protein A Resin: Fouling and Economics
Hence, the resulting demand for the drug can be several hundred kilos of product per year or more (10).
Another important consideration for bioprocessing applications is throughput (11, 12). Becau…
Article
Detecting Protein Aggregates and Evaluating their Immunogenicity
Regulatory agencies are increasingly asking drug manufacturers to characterize particulate matter in biologics.
Unfortunately, there is little general agreement about how to handle the problem of …
Article
SEC in the Modern Downstream Purification Process
Because the drug is generally in the size range of 500 to 2000 Da, the conjugated form of the antibody, in excess of 150,000 Da, is easily separated using SEC. The cytotoxic payload molecule is genera…
Article
What Drove Biopharma Development in 2014?
…d rejects, minimize post-approval changes, streamline data flows across the entire life cycle of the drug, and improve overall efficacy and cost-efficacy for patients and manufacturers. So, it is no …
Article
Optimizing Resin Performance with Disposable Chromatography Solutions
The chromatography medium is the means by which protein purification is performed, and it must perform as expected, otherwise the purity of the drug can be impaired. Customers have expressed that they…
Article
DoE Provides Benefits, but Preparation Is Necessary
…ltivariate design space and the subsequent justification of formulation components when developing a drug product, according to Steven R. LaBrenz, scientific director, pharmaceutical development and …
Article
A Q&A With Dr. Anurag Rathore About the Future of QbD, Part 2
This two-part Q&A series with Anurag Rathore, PhD, Professor, Department of Chemical Engineering, Indian Institute of Technology, Delhi, reveals the evolution of QbD, the types of companies implementi…
Article
A Q&A With Dr. Anurag Rathore About the Future of QbD, Part I
This two-part Q&A series with Anurag Rathore, PhD, Professor, Department of Chemical Engineering, Indian Institute of Technology, Delhi, reveals the evolution of QbD, the types of companies implemen…