Search results for " detection"
Article
Impurity Testing of Biologic Drug Products
…flight mass spectrometry (MALDI–TOF MS), LC–MS, and other liquid chromatography with ultraviolet detection (LC–UV) or high-pressure anion exchange chromatography coupled to pulsed amperometric detect…
Article
N-Glycan Analysis of Biotherapeutic Proteins
…e; RP=reverse-phase; HPAE-PAD=high performance anionexchange chromatography with pulsed amperometric detection.
To determine glycosylation site occupancy, glycoproteins may be broken down into…
Article
Application of Quality by Design to Viral Safety
The volume of raw material tested in an assay may be so small that detection of a viral contaminant is beyond the sensitivity of the assay. Adventitious viruses may not be detectable during sampling i…
Article
Quality by design for biotechnology products—part 1
The ability to detect a quality attribute during product development is required to assess its occurrence, thus necessitating the development of methods suitable for this detection and quantitation. T…
Article
Emerging Therapies Test Existing Bioanalytical Methods
Assay validation includes evaluation of intra- and inter-assay precision and accuracy, specificity and selectivity, limit of detection, and stability. Expression of the gene therapy product should als…
Article
Evaluating E&L Studies for Single-Use Systems
Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
By Irene Cecchini, Daniele Mastroianni, Silvia Rocchi, Gabriella Angiuoni
Biop…
Article
QbD and PAT in Upstream and Downstream Processing
To gain perspective on the implementation of quality by design (QbD) and process analytical technology (PAT) in biopharmaceutical processing, BioPharm International spoke with Clinton Weber, as…
Article
Virus-like Particles as Therapeutic Moieties of the Future
The high sensitivity of this technique facilitates detection of even single amino acid changes (15). PTMs such as glycosylation can also be analyzed using lectin-based glycan differentiation assay (16…
Article
A Look Ahead at BioPharma Manufacturing and Regulation
Studies are ongoing on sterilizing filtration, effects of terminal sterilization energies on classes of products, and methods for detection of elusive microorganisms in drug components and manufacturi…
Article
Best Practices for Data Integrity
Nelson (DataNinja): Detection of data manipulation has got to be built into the computerized system. Advanced computerized systems leverage MD5 hash encryption to verify that original data integrity r…