Search results for "regulatory"
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Biopharma Says It Has an Evolution in New Technologies and Processes
This week, the Process Development Forum interviews Rita Peters, editorial director of BioPharm International, about Interphex 2018.
At the 2018 Interphex trade show in New York City in April…
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NIST Spectroscopic Measurement Standards
NIST Spectroscopic Measurement Standards
The National Institute of Standards and Technology (NIST) has developed Standard Reference Material (SRM) 2082 as a pathlength standard for UV absorbance mea…
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Full Single-Use Downstream Process? Not Any Time Soon.
Single-use technologies (SUTs) are here to stay. But where we see full single-use upstream processes, downstream is often a hybrid solution. Here’s why SUTs will not completely replace reuse systems…
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Taking Prepacked Columns to Manufacturing Scale
Prepacked chromatography columns in biomanufacturing can save time, but also present concerns related to delivery lead times, capacity, and operational cost.
Learn more here about ways to address…
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Impurity Testing of Biologic Drug Products
Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.
By Adeline Siew, PhD
CA-SSIS/shutterstock.comIm…
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Exotoxin Clearance from mAb Samples in a Two-Step Chromatography Process
A heat-stable exotoxin can remain as a contaminant of a drug substance throughout the whole manufacturing process, with the risk of adversely affecting patients’ health. One such toxin is cereulide …
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QbD Improves Cell-Culture Process Control
QbD Improves Cell-Culture Process Control
A quality-by-design approach that implements PAT offers advantages in upstream cell-culture processing.
By Feliza Mirasol
Mar…
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What You Need to Know about Continuous Processing
There is a lot of interest around continuous biomanufacturing, and it is expected to have a significant impact on the biomanufacturing industry over the next few years. Continuous processing can hel…
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Performance of Single-Use Xcellerex™ XDR‑500 MO and XDR‑50 MO Stirred-Tank Fermentor Systems
This application note describes the performance of the XDR‑500 MO fermentor system in comparison with the XDR‑50 MO fermentor. Domain antibody production in E. coli was used as the model process. …
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ADC Development Robust Despite Lackluster Performance
The company plans to submit regulatory filings for these indications in 2020 or later (11).
In addition to these combination-use clinical trials, Roche is also conducting two Phase III clinical…