Search results for " industry"
Article
Managing Risk in Biomanufacturing
With patients’ lives dependent on a continuous supply of high-quality drugs and vaccines, it is essential to have consistency within the industry on how to manage risks. Today’s business environment r…
Article
Fusion Proteins Pose Manufacturability Challenges
… half-life,” explains Steven Chamow, a principal with Chamow & Associates, a biopharmaceutical industry consultancy.
Specifically, two or more proteins are joined in one polypeptide chain, in som…
Article
Critical Quality Attributes Challenge Biologics Development
BioPharm: As biologics become more popular in the industry, are companies paying more attention to risk assessment and QbD for these products?
Das (BMS): Generally, yes. Risk assessment still diff…
Article
Speed and Flexibility Are Dual Goals for Biopharma Operations
To assist the adoption of single-use systems, industry organizations, such as the BioPhorum Operations Group and Bio-Process Systems Alliance, are addressing concerns about extractables and leachables…
Article
Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
The problem of copying biologics
Biologic drugs have revolutionized the pharmaceutical industry by attacking disease using the mechanisms of the cell and immune system. These therapies are fragile…
Article
Single-use Bioreactors Have Reached the Big Time
Norris agrees that in addition to longer life-times for new processes, the industry is actively seeking single-use sensors with better accuracy and precision. She does note, however, that the state of…
Article
Reconciling Sensor Communication Gaps
To manage these complexities, Emerson is betting on augmented reality—a technology under evaluation in the oil and gas industry—which the company believes could help the design and validation of bioma…
Article
Single-Use Extractables and Leachables: Cytiva's Alignment with the BPOG Protocol
Copious amounts of data have been generated by the industry, but most of it is held under confidentiality. Trade organizations, such as the Bio-Process Systems Alliance (BPSA) and suppliers have deriv…
Article
Establishing Acceptance Criteria for Analytical Methods
FDA, Analytical Procedures and Methods Validation for Drugs and Biologics, Guidance for Industry (CDER, July 2015).
7. T. Little, Accuracy to Precision (ATP) Profiler.
Article
Real Time Continuous Microbiological Monitoring
Conclusion
The pharmaceutical industry is moving toward continuous manufacturing and control to ensure full understanding of the aseptic manufacturing process and product quality. Envi…