Search results for "analytical" in Articles / App Notes
Article
Setting Up Bioprocessing Systems for Digital Transformation
Lenich says that with the increased complexity inherent in mAb manufacturing, there is a new focus on process analytical technology (PAT) to ensure that not only are measurements correct, complete, an…
Article
Driving Improved Access to Biosimilars
The agency also published draft guidance on the analytical methods to be used to establish biosimilar comparability and quality (12). According to reports on May 13 and May 21 in the Regulatory Affair…
Article
Development of Purification for Challenging Fc-Fusion Proteins
1]
Analytical techniques
Protein concentration was measured using a NanoDrop 2000 (Thermo Fisher Scientific). Microplate protein concentration analysis was measured using a S…
Article
Reconciling Sensor Communication Gaps
Process analytical technology (PAT), quality by design, and individual company- or process-centric quality initiatives are driving the development of bioprocess sensors and probes. Single-use systems …
Article
Lessons Learned Accelerate Vaccine Development
“The lack of true platforms, with a few exceptions, means that there is a lack of standard cell lines with associated process and analytical frameworks for the manufacturing and release of products,” …
Article
Ligand-Binding Assays and the Determination of Biosimilarity
“Only a functional assay, such as an LBA or CBA, can fully address this issue,” says Michael Sadick, senior manager for large molecule analytical chemistry with Catalent Pharma Solutions.
For mono…
Article
2014 Manufacturing Trends and Outlook
Process analytical technologies
More than half of the respondents reported using process analytical technology (PAT) in manufacturing operations. High-performance liquid chromatography was th…
Article
A Look Ahead at BioPharma Manufacturing and Regulation
…s manufacturing, novel manufacturing technologies, excipients and complex dosage forms, and process analytical technology (PAT) and quality-by-design (QbD) approaches. What does FDA and the industry …
Article
Moving Biosimilars Forward in a Hesitant Market
However, Gabrielson clarifies, what most people don’t realize is that the amount of data from a CMC perspective, and particularly data demonstrating analytical similarity, is the same or higher than w…
Article
Good Manufacturing Practices: Challenges with Compliance
Second, ensure that you have a strong analytical team working with you, whether that’s internally or through a partnership with a CDMO. The equipment and methods for biologics analytical work are very…