Search results for " raw materials"
Article
Use of Multivariate Data Analysis in Bioprocessing
This approach made it possible to fingerprint the raw materials and distinguish the performance between good and poor media lots.
Figure 3: Use of near-infrared spectroscopy (NIR-MVDA) for screeni…
Article
Securing the Single-Use Supply Chain
…SO 22301 and achieving conformance to this standard), including qualifying dual sources for critical raw materials and a significant investment in safety stock. These efforts have delivered supply-ch…
Article
Essentials in Establishing and Using Design Space
Knowledge of product or process acceptance criterion is crucial in design space.
Design space is generally considered to be the areas where the product or process parameters can be run safe…
Article
Optimizing Resin Performance with Disposable Chromatography Solutions
At its simplest, the answer requires a comparison of the tasks, labor time, labor rate, raw materials, and overhead to pack a glass column on site and prepare it for use in a GMP suite with a similar …
Article
Genetic Vaccine Platforms Demonstrate Their Potential
She highlights a need for the reduction of costs for raw materials and manufacturing processes and improvements in stability to reduce the need for storage at low or extremely low temperatures, which …
Article
The New World of Biopharmaceutical Manufacturing
Most significantly, biopharmaceutical companies need vendors to commit to providing a high level of assurance of consistent supply with robust supply chains and highly characterized processes and raw …
Article
Design and Qualification of Single-Use Systems
… same design requirement statement: “Equipment should be constructed so that surfaces that contact raw materials, intermediates, or APIs do not alter the quality of the intermediates and APIs beyond …
Article
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Asking the right questions is crucial to establishing a facility design.
By Peter Genest, John Joseph
The benefits of adopting single-use technologies in the production of biopharmaceuticals…
Article
Good Manufacturing Practices: Challenges with Compliance
WrightStudio/Stock.Adobe.com
The complexity of biologics and the use of new technologies present challenges for complying with CGMPs.
By Lauren Lavelle
…
Article
Optimizing Late-Stage and Commercial Cell-Culture Processes
The security of obtaining supply for raw materials with the desired profile of contaminants and impurities is one example.
“With raw materials becoming ever more purified, trace levels of impu…