Search results for " raw materials"
Article
Application of Quality by Design to Viral Safety
Using this approach, products are developed with a thorough understanding of how the raw materials and manufacturing processes impact the eventual clinical performance of the final drug product. QbD f…
Article
Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
…ch as bovine sources, and also to require stringent testing and justification for any animal-sourced raw materials used in producing biopharmaceuticals, even for materials that are not associated wit…
Article
Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
Along with the time involved, there are many other challenges with this process (3):
Intrusive physical sampling of powder raw materials requires rapid material usage post-sampling to c…
Article
Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical manufacturers’ change-control systems are designed to ensure that any changes to raw materials, product contact materials, manufacturing methods, product tests, and production equipment…
Article
Applying GMPs to the BioPharma Supply Chain
Suppliers share a commensurate responsibility, as the quality of raw materials has a direct impact on these goals. There is an acknowledged gap between current capabilities of many suppliers and what …
Article
A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
By Satish Mallya, Benjamin Lay, Lihong McAleer, Alexandria Emory, Nataliya Afonina
Abstract
Cell-culture media are essential raw materials that are required for the manufacture of biotherapeut…
Article
Ensuring Viral Safety of Viral Vaccines and Vectors
…nbsp;• Preventing entry of contamination into production processes by ensuring the quality of raw materials
• Detecting contaminants by characterization of cell banks/virus seed stocks and by…
Article
Regulatory Challenges in the QbD Paradigm
Even for those drugs that are manufactured in the US, a significant portion of the raw materials and process intermediates is imported from manufacturers outside the US. It's no wonder that "Supply Ch…
Article
What’s in your media? How costly is variability of cell culture media to your manufacturing process?
We use the finest raw materials we can find compendial grade, which are 99.5% pure. However, if there are several different components then there is an additive effect for impurities that are present.…
Article
Eliminating Residual Impurities Starts with a Strategic Plan
Numerous risk factors
Residual impurities in biopharmaceutical processes can be traced back to raw materials or can form during upstream or downstream processing steps and upon storage. They can b…