Search results for " process" in Articles / App Notes
Article
Selecting the Right Viral Clearance Technology
Several factors must be considered when making this selection: the clearance requirements, the properties of the target protein, the mechanism(s) of the clearance method(s), and the impact of process …
Article
Host-Cell Protein Measurement and Control
Risks Associated with HCPs
HCPs constitute a major group of process-related impurities in a drug product. The risks associated with HCPs are primarily immunogenicity. HCPs are complex mixtures wit…
Article
Challenges of Protein Aggregation During Purification
…able conditions are selected for downstream operations, aggregation can also occur during downstream processing.
Aggregation mechanisms
There are essentially two mechanisms leading to aggrega…
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
Cell therapy starting material—where does it feed into critical process points?
Donor recruitment: Necessary at each stage of clinical testing. Must have a strong donor netw…
Article
Ensuring Viral Safety of Viral Vaccines and Vectors
PCVs entered vaccine processes via porcine trypsin, a common cell-culture reagent. In 2014, using next-generation sequencing (NGS), FDA’s Center for Biologics Evaluation and Research (CBER) retrovirus…
Article
Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical change management processes extend to the materials and services employed to manufacture and test drug products, necessitating the need for an effective supplier-initiated change (SIC) …
Article
State of the Biopharmaceutical Industry: Lessons from 2018 Survey Data
…doption of continuous bioprocessing, but also expectations, hopes, and plans to implement continuous processing. This is despite the fact that available technologies in this area are mostly not yet r…
Article
Putting Viral Clearance Capabilities to the Test
When applying for regulatory approval, a drug license holder must demonstrate that its proposed manufacturing process can remove or inactivate potential viral contaminants.
Viral clearance studies…
Article
Critical Quality Attributes Challenge Biologics Development
By Susan Haigney
Critical quality attributes (CQAs) are used in biopharmaceutical development to gain an understanding of a product and the processes used to make that product. The International C…
Article
Biopharma Advances Demand Specialized Expertise
Regulatory and business trends
BioPharm: What regulatory changes have positively or negatively impacted biopharmaceutical development/manufacturing processes?
McNally (PPD Consulting): FDA estab…